Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial. A Prospective Randomized Study Comparing Two Different Degrees of Mandibular Advancement with a Dental Appliance in Treatment of Severe Obstructive Sleep Apnea Mandibular advancement devices in 630 men and women with obstructive sleep apnea and snoring: tolerability and predictors of treatment success. The Combination of Supplemental Oxygen and a Hypnotic Markedly Improves Obstructive Sleep Apnea in Patients with a Mild to Moderate Upper Airway Collapsibility. Propofol-induced sleep: Polysomnographic evaluation of patients with obstructive sleep apnea and controls Long-term oral appliance therapy in obstructive sleep apnea syndrome: a controlled study on dental side effects The occurrence of sleep-disordered breathing among middle-aged adults. The effects of Provent on moderate to severe obstructive sleep apnoea during continuous positive airway pressure therapy withdrawal: a randomised controlled trial Mandibular advancement titration for obstructive sleep apnea: optimization of the procedure by combining clinical and oximetric parameters. Increased prevalence of sleep-disordered breathing in adults. Upper-airway stimulation for obstructive sleep apnea. Effect of upper-airway stimulation for obstructive sleep apnoea on airway dimensions Mandibular advancement device and CPAP upon cardiovascular parameters in OSA Nerve monitoring-guided selective hypoglossal nerve stimulation in obstructive sleep apnea patients. A novel nasal expiratory positive airway pressure (EPAP) device for the treatment of obstructive sleep apnea: a randomized controlled trial. A crossover randomised controlled trial of oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea (TOMADO) Microvascular endothelial function in obstructive sleep apnea: Impact of continuous positive airway pressure and mandibular advancement. Effects of Oropharyngeal Exercises on Snoring: A Randomized Trial. Three-Year Outcomes of Cranial Nerve Stimulation for Obstructive Sleep Apnea Dose-dependent effects of mandibular advancement on pharyngeal mechanics and nocturnal oxygenation in patients with sleep-disordered breathing. Long-term use of a nasal expiratory positive airway pressure (EPAP) device as a treatment for obstructive sleep apnea (OSA). Effect of speech therapy as adjunct treatment to continuous positive airway pressure on the quality of life of patients with obstructive sleep apnea. Randomised sham-controlled trial of transcutaneous electrical stimulation in obstructive sleep apnoea Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome. Long-term oral appliance therapy in obstructive sleep apnea syndrome: a controlled study on temporomandibular side effects Efficacy of positive airway pressure and oral appliance in mild to moderate obstructive sleep apnea. CPAP for Prevention of Cardiovascular Events in Obstructive Sleep Apnea. A multicenter evaluation of oral pressure therapy for the treatment of obstructive sleep apnea.
RATIONALE Continuous positive airway pressure ( CPAP ) and m and ibular advancement device ( MAD ) therapy are commonly used to treat obstructive sleep apnea ( OSA ) . Differences in efficacy and compliance of these treatments are likely to influence improvements in health outcomes . OBJECTIVES To compare health effects after 1 month of optimal CPAP and MAD therapy in OSA . METHODS In this r and omized crossover trial , we compared the effects of 1 month each of CPAP and MAD treatment on cardiovascular and neurobehavioral outcomes . MEASUREMENTS AND MAIN RESULTS Cardiovascular ( 24-h blood pressure , arterial stiffness ) , neurobehavioral ( subjective sleepiness , driving simulator performance ) , and quality of life ( Functional Outcomes of Sleep Question naire , Short Form-36 ) were compared between treatments . Our primary outcome was 24-hour mean arterial pressure .  A total of 126 patients with moderate-severe OSA ( apnea hypopnea index [ AHI ] , 25.6 [ SD 12.3 ] ) were r and omly assigned to a treatment order and 108 completed the trial with both devices . CPAP was more efficacious than MAD in reducing AHI ( CPAP AHI , 4.5 ± 6.6/h ; MAD AHI , 11.1 ± 12.1/h ; P < 0.01 ) but reported compliance was higher on MAD ( MAD , 6.50 ± 1.3 h per night vs. CPAP , 5.20 ± 2 h per night ; P < 0.00001 ) . The 24-hour mean arterial pressure was not inferior on treatment with MAD compared with CPAP ( CPAP-MAD difference , 0.2 mm Hg [ 95 % confidence interval , -0.7 to 1.1 ] ) ; however , overall , neither treatment improved blood pressure . In contrast , sleepiness , driving simulator performance , and disease-specific quality of life improved on both treatments by similar amounts , although MAD was superior to CPAP for improving four general quality -of-life domains . CONCLUSIONS Important health outcomes were similar after 1 month of optimal MAD and CPAP treatment in patients with moderate-severe OSA . The results may be explained by greater efficacy of CPAP being offset by inferior compliance relative to MAD , result ing in similar effectiveness . Clinical trial registered with https://www.anzctr.org.au ( ACTRN 12607000289415 ) The objective of this study was to compare the effect of two different degrees of m and ibular advancement ( MA ) , 75 % versus 50 % , on somnographic variables after 6 months of dental appliance treatment in patients with severe obstructive sleep apnea ( OSA ) . A further purpose was to compare the number of adverse events on the stomatognathic system and the effects of dental appliance treatment on the presence of daytime sleepiness . Eighty-six males with severe OSA ( apnea index ≥ 20 ) were r and omly allocated to either 75 % or 50 % MA . Forty patients in the 75 % MA group and 37 patients in the 50 % MA group completed the 6-month follow-up . The effectiveness of treatment in terms of normalization ( apnea index < 5 and apnea/hypopnea index < 10 ) with 75 % MA was 52 % , which was significantly higher ( p = 0.04 ) than the 31 % achieved with 50 % MA . The dental appliance had few adverse events on the stomatognathic system regardless of group , and the number of adverse events did not differ between the two groups . Finally , the mean value of Epworth Sleepiness Scale scores decreased significantly from 11.6 at baseline to 8.0 at follow-up ( p < 0.001 ) . No significant difference was observed between the two groups . The results indicate that a dental appliance could be an alternative treatment for some patients with severe OSA STUDY OBJECTIVE To evaluate the tolerability and to find predictors of treatment success for an individually adjusted , one-piece m and ibular advancement device in patients with snoring and obstructive sleep apnea . DESIGN Prospect i ve study . SETTING Departments of Respiratory Medicine and Orthodontics , Umeå University . PATIENTS Six hundred nineteen of 630 patients ( 98 % ) , who consecutively received treatment for sleep apnea and snoring from February 1989 to August 2000 , were followed up . They had a mean apnea-hypopnea index of 16 ( range , 0.0 to 76 ) and a mean body mass index of 28 ( range , 19 to 42 ) . MEASUREMENTS Interviews , question naires , and  overnight sleep apnea recordings .  Patients with an apnea-hypopnea index of > or=10 in the supine and /or lateral position were considered to have obstructive sleep apnea . A lateral apnea-hypopnea index of < 10 , together with a supine apnea-hypopnea index of > or= 10 , defined supine-dependent sleep apneas . RESULTS One hundred forty-eight of the 619 patients ( 24 % ) discontinued treatment . Female gender predicted treatment success , defined as an apnea-hypopnea index of < 10 in both the supine and lateral positions , with an odds ratio of 2.4 ( p = 0.01 ) . In the women , the odds ratios for treatment success were 12 for mild sleep apnea ( p = 0.04 ) , and 0.1 for complaints of nasal obstruction ( p = 0.03 ) . In the men , the odds ratios for treatment success were 6.0 for supine-dependent sleep apneas ( p < 0.001 ) , 2.5 for mild sleep apnea ( p = 0.04 ) , 1.3 for each millimeter of m and ibular advancement ( p = 0.03 ) , and 0.8 for each kilogram of weight increase ( p = 0.001 ) . CONCLUSIONS The m and ibular advancement device is recommended for women with sleep apnea , for men with supine-dependent sleep apneas defined by a lateral apnea-hypopnea index of < 10 , and for snorers without sleep apnea . Men who increase in weight during treatment reduce their chance of treatment success and are advised to be followed up with a new sleep apnea recording with the device STUDY OBJECTIVES Obstructive sleep apnea ( OSA ) results from the interaction of several physiological traits ; specifically a compromised upper airway anatomy and muscle function , and two key non-anatomical deficits : elevated loop gain and a low arousal threshold . Although continuous positive airway pressure ( CPAP ) is an efficacious treatment , it is often poorly tolerated . An alternative approach could involve administering therapies targeting the non-anatomic causes . However , therapies ( oxygen or hypnotics ) targeting these traits in isolation typically improve , but rarely resolve OSA . Therefore , our aim was to determine how the combination of oxygen and eszopiclone alters the phenotypic traits and OSA severity and to assess the baseline phenotypic characteristics of responders/nonresponders to combination therapy . METHODS In a single-blinded r and omized crossover study , 20 OSA patients received combination therapy ( 3 mg eszopiclone and 40 % oxygen ) versus placebo/sham air , with 1 w between conditions . Under each condition , we assessed the effects on OSA severity ( clinical polysomnography ) and the phenotypic traits causing OSA using CPAP manipulations ( research polysomnography ) . RESULTS Combination therapy reduced the apnea-hypopnea index ( 51.9 ± 6.2 vs. 29.5 ± 5.3 events/h ; P < 0.001 ) , lowered both the ventilation associated with arousal ( 5.7 ± 0.3 vs. 5.2 ± 0.3 L/min ; P = 0.05 ) and loop gain ( 3.3 ± 0.5 vs. 2.2 ± 0.3 ; P = 0.025 ) . Responders to therapy ( apnea-hypopnea index reduced by > 50 % to below 15 events/h ; n = 9/20 ) had less severe OSA ( P = 0.001 ) , a less collapsible upper airway ( P = 0.01 ) and greater upper airway muscle effectiveness ( P = 0.002 ) . CONCLUSIONS The combination of lowering loop gain and raising the arousal threshold is an effective therapy in patients whose anatomy is not severely compromised . Our work demonstrates that combining therapies that target multiple traits can resolve OSA in selected individuals . CLINICAL TRIAL REGISTRATION Clinical Trials.gov , ID : NCT01633827 Objective : The localization of upper airway obstruction in patients with obstructive sleep apnea ( OSA ) may optimize treatment . Nasoendoscopy during propofol sedation allows such an evaluation , but the effect of this drug on respiratory patterns and muscle relaxation is unknown . The objective of the present study was to determine through polysomnography whether propofol would change sleep parameters . Study Design : Prospect i ve study of subjects su bmi tted to polysomnography  under sedation with propofol . Setting : Tertiary referral center . Subjects and Methods : Fifteen non-obese subjects ( 4 controls/11 OSA patients ) were su bmi tted to two diurnal polysomnograms ( 90 - 120 minutes of sleep ) , with and without the use of propofol . The parameters presence of snoring , apnea-hypopnea index ( AHI ) , oxygen desaturation , and sleep architecture were compared . Results : The use of propofol did not induce snoring in the control subjects , whereas 100 percent of the OSA patients snored . AHI and mean oxygen saturation ( SaO2 ) did not differ significantly between examinations with and without sedation . However , minimum SaO2 differed significantly ( P < 0.05 ) with sedation , being lower during propofol sedation . Propofol also significantly changed the sleep architecture , with a significant increase in N3 sleep ( P < 0.005 ) and total abolishment of rapid eye movement sleep ( P < 0.0005 ) during propofol sedation . Conclusions : These preliminary results allow us to infer that sedation with propofol changes sleep architecture but permits respiratory evaluation , because the main respiratory parameters evaluated in OSA are maintained . These preliminary results support the view that nasoendoscopy under propofol sedation is a promising examination for management of this disease Objectives This study aim ed to assess possible dental side effects associated with long-term use of an adjustable oral appliance compared with continuous positive airway pressure ( CPAP ) in patients with the obstructive sleep apnea syndrome and to study the relationship between these possible side effects and the degree of m and ibular protrusion associated with oral appliance therapy . Material s and methods As part of a previously conducted RCT , 51 patients were r and omized to oral appliance therapy and 52 patients to CPAP therapy .  At baseline and after a 2-year follow-up , dental plaster study models in full occlusion were obtained which were thereupon analyzed with respect to relevant variables . Results Long-term use of an oral appliance result ed in small but significant dental changes compared with CPAP . In the oral appliance group , overbite and overjet decreased 1.2 ( ±1.1 ) mm and 1.5 ( ±1.5 ) mm , respectively . Furthermore , we found a significantly larger anterior – posterior change in the occlusion ( −1.3 ± 1.5 mm ) in the oral appliance group compared to the CPAP group ( −0.1 ± 0.6 mm ) . Moreover , both groups showed a significant decrease in number of occlusal contact points in the (pre)molar region . Linear regression analysis revealed that the decrease in overbite was associated with the mean m and ibular protrusion during follow-up [ regression coefficient ( β ) = −0.02 , 95 % confidence interval ( −0.04 to −0.00 ) ] . Conclusions Oral appliance therapy should be considered as a lifelong treatment , and there is a risk of dental side effects to occur . Clinical relevance Patients treated with the oral appliance need a thorough follow-up by a dentist or dental-specialist experienced in the field of dental sleep medicine BACKGROUND Limited data have suggested that sleep-disordered breathing , a condition of repeated episodes of apnea and hypopnea during sleep , is prevalent among adults . Data from the Wisconsin Sleep Cohort Study , a longitudinal study of the natural history of cardiopulmonary disorders of sleep , were used to estimate the prevalence of undiagnosed sleep-disordered breathing among adults and address its importance to the public health . METHODS A r and om sample of 602 employed men and women 30 to 60 years old were studied by overnight polysomnography to determine the frequency of episodes of apnea and hypopnea per hour of sleep ( the apnea-hypopnea score ) . We measured the age- and sex-specific prevalence of sleep-disordered breathing in this group using three cutoff points for the apnea-hypopnea score ( > or = 5 , > or = 10 , and > or = 15 ) ; we used logistic regression to investigate risk factors . RESULTS The estimated prevalence of sleep-disordered breathing , defined as an apnea-hypopnea score of 5 or higher , was 9 percent for women and 24 percent for men . We estimated that 2 percent of women and 4 percent of men in the middle-aged work force meet the minimal diagnostic criteria for the sleep apnea syndrome ( an apnea-hypopnea score of 5 or higher and daytime hypersomnolence ) . Male sex and obesity were strongly associated with the presence of sleep-disordered breathing . Habitual snorers , both men and women , tended to have a higher prevalence of apnea-hypopnea scores of 15 or higher . CONCLUSIONS The prevalence of undiagnosed sleep-disordered breathing is high among men and is much higher than previously suspected among women . Undiagnosed sleep-disordered breathing is associated with daytime hypersomnolence Objectives The aim of this study was to test the effectiveness of Provent , an expiratory nasal resistance valve , to prevent the recurrence of OSA following CPAP withdrawal . Design R and omised , partially blinded , parallel , placebo-controlled trial . Setting Outpatient sleep clinics in the UK ( Oxford ) and Switzerl and ( Zurich ) . Participants 67 patients with OSA receiving CPAP were r and omised to one of three groups for 2 weeks : continuing CPAP , Provent or placebo Provent . Main outcome measures Primary outcomes included for Provent versus placebo Provent , OSA severity ( oxygen desaturation index ( ODI ) , apnoea – hypopnoea index ( AHI ) ) and Epworth Sleepiness Scale ( ESS ) score . Secondary outcomes for Provent versus placebo Provent included ODI from ambulatory pulse oximetry and blood pressure ( BP ) . For CPAP versus Provent , or CPAP versus placebo Provent , secondary outcomes included ODI/AHI , ESS and BP . Results 63 patients were included in the per protocol analysis . OSA recurred in the Provent ( ODI 35.8 , SD 17.4 ) and placebo Provent ( ODI 28.2 , SD 18.3 ) groups , and there was no significant difference in ODI , AHI and ESS between Provent and placebo Provent at 2 weeks ( mean difference ODI −1.0 , 95 % CI −10.0 to + 12.0 , p=0.85 ; AHI + 3.2 , 95 % CI −7.7 to + 14.1 , p=0.52 ; and ESS −1.4 , 95 % CI −4.1 to + 1.4 , p=0.33 ) . ODI from ambulatory pulse-oximetry and BP at 2 weeks were not different in the Provent versus placebo Provent groups . ODI , AHI and BP , but not ESS , were significantly higher in the Provent and placebo Provent groups compared with CPAP . Conclusions Provent can not be recommended as an alternative short-term therapy for patients with moderate to severe OSA already on CPAP . TrialRegNo NCT01332175 BACKGROUND Oral appliances ( OAs ) have been used for the treatment of obstructive sleep apnea syndrome ( OSAS ) , with different degrees of effectiveness having been shown in previous studies . But , in the absence of a consensual recommendation , the method of the determination of effective m and ibular advancement varies from one study to another . STUDY OBJECTIVE We prospect ively evaluated an OA titration protocol based on a combined analysis of symptomatic benefit and oximetric recording to guide the progressive m and ibular advancement . SETTING University hospital sleep disorders center . PATIENTS Forty patients with OSAS ( mean [ + /-SD ] apnea-hypopnea index [ AHI ] , 46 + /- 21 events per hour ) found on baseline polysomnography , who were intolerant of nasal continuous positive airway pressure , completed all aspects of the study . METHODS Two acrylic appliances connected by Herbst attachments were constructed . The m and ible was advanced 1 mm every week until there was a resolution of the symptoms and a reduction in the oxygen desaturation index ( ie , the number of desaturations yielding a > 3 % fall in pulse oximetric saturation per hour of recording ) [ ODI ] of < 10 events per hour of recording or a maximum comfortable limit of advancement was obtained . The final response to OA was evaluated by full polysomnography recording . RESULTS A complete response ( ie , mean AHI , 5 + /- 3 events per hour ; mean snoring reduction [ SR ] , 91 + /- 13 % ; mean Epworth sleepiness scale [ ESS ] score , 5 + /- 3 ) was obtained in 63.6 % of patients , and a limited response ( ie , mean AHI , 21 + /- 11 events per hour ; mean SR , 88 + /- 15 % ; mean ESS , 6 + /- 3 ) was obtained in 18.2 % of patients . Twenty-five percent of m and ibular advancements were motivated by an abnormal ODI ( ie , 21 + /- 10 events per hour ) despite resolution of the symptoms , while 20 % were motivated by persistent symptoms with a normal ODI ( ie , 6 + /- 2 events per hour ) . After a mean duration of 17 + /- 4 months , 34 patients declared that they had used the OA 5 + /- 2 days a week for 89 + /- 19 % of their sleep time . CONCLUSIONS A combination of the patient 's subjective evaluation and oximetric score improves the effectiveness of the OA titration procedure Sleep-disordered breathing is a common disorder with a range of harmful sequelae . Obesity is a strong causal factor for sleep-disordered breathing , and because of the ongoing obesity epidemic , previous estimates of sleep-disordered breathing prevalence require updating . We estimated the prevalence of sleep-disordered breathing in the United States for the periods of 1988 - 1994 and 2007 - 2010 using data from the Wisconsin Sleep Cohort Study , an ongoing community-based study that was established in 1988 with participants r and omly selected from an employed population of Wisconsin adults . A total of 1,520 participants who were 30 - 70 years of age had baseline polysomnography studies to assess the presence of sleep-disordered breathing . Participants were invited for repeat studies at 4-year intervals . The prevalence of sleep-disordered breathing was modeled as a function of age , sex , and body mass index , and estimates were extrapolated to US body mass index distributions estimated using data from the National Health and Nutrition Examination Survey . The current prevalence estimates of moderate to severe sleep-disordered breathing ( apnea-hypopnea index , measured as events/hour , ≥15 ) are 10 % ( 95 % confidence interval ( CI ) : 7 , 12 ) among 30 - 49-year-old men ; 17 % ( 95 % CI : 15 , 21 ) among 50 - 70-year-old men ; 3 % ( 95 % CI : 2 , 4 ) among 30 - 49-year-old women ; and 9 % ( 95 % CI : 7 , 11 ) among 50 - 70 year-old women . These estimated prevalence rates represent substantial increases over the last 2 decades ( relative increases of between 14 % and 55 % depending on the subgroup ) BACKGROUND Obstructive sleep apnea is associated with considerable health risks . Although continuous positive airway pressure ( CPAP ) can mitigate these risks , effectiveness can be reduced by inadequate adherence to treatment . We evaluated the clinical safety and effectiveness of upper-airway stimulation at 12 months for the treatment of moderate-to-severe obstructive sleep apnea . METHODS Using a multicenter , prospect i ve , single-group , cohort design , we surgically implanted an upper-airway stimulation device in patients with obstructive sleep apnea who had difficulty either accepting or adhering to CPAP therapy . The primary outcome measures were the apnea-hypopnea index ( AHI ; the number of apnea or hypopnea events per hour , with a score of ≥15 indicating moderate-to-severe apnea ) and the oxygen desaturation index ( ODI ; the number of times per hour of sleep that the blood oxygen level drops by ≥4 percentage points from baseline ) . Secondary outcome measures were the Epworth Sleepiness Scale , the Functional Outcomes of Sleep Question naire ( FOSQ ) , and the percentage of sleep time with the oxygen saturation less than 90 % . Consecutive participants with a response were included in a r and omized , controlled therapy-withdrawal trial . RESULTS The study included 126 participants ; 83 % were men . The mean age was 54.5 years , and the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 28.4 .  The median AHI score at 12 months decreased 68 % , from 29.3 events per hour to 9.0 events per hour ( P<0.001 ) ; the ODI score decreased 70 % , from 25.4 events per hour to 7.4 events per hour ( P<0.001 ) . Secondary outcome measures showed a reduction in the effects of sleep apnea and improved quality of life . In the r and omized phase , the mean AHI score did not differ significantly from the 12-month score in the nonr and omized phase among the 23 participants in the therapy-maintenance group ( 8.9 and 7.2 events per hour , respectively ) ; the AHI score was significantly higher ( indicating more severe apnea ) among the 23 participants in the therapy-withdrawal group ( 25.8 vs. 7.6 events per hour , P<0.001 ) . The ODI results followed a similar pattern . The rate of procedure-related serious adverse events was less than 2 % . CONCLUSIONS In this uncontrolled cohort study , upper-airway stimulation led to significant improvements in objective and subjective measurements of the severity of  obstructive sleep apnea . ( Funded by Inspire Medical Systems ; STAR Clinical Trials.gov number , NCT01161420 . ) Upper-airway stimulation ( UAS ) using a unilateral implantable neurostimulator for the hypoglossal nerve is an effective therapy for obstructive sleep apnoea patients with continuous positive airway pressure intolerance . This study evaluated stimulation effects on retropalatal and retrolingual dimensions during drug-induced sedation compared with wakefulness to assess mechanistic relationships in response to UAS . Patients with an implanted stimulator underwent nasal video endoscopy while awake and /or during drug-induced sedation in the supine position . The cross-sectional area , anterior – posterior and lateral dimensions of the retropalatal and retrolingual regions were measured during baseline and stimulation . 15 patients underwent endoscopy while awake and 12 underwent drug-induced sedation endoscopy .  Increased levels of stimulation were associated with increased area of both the retropalatal and retrolingual regions . During wakefulness , a therapeutic level of stimulation increased the retropalatal area by 56.4 % ( p=0.002 ) and retrolingual area by 184.1 % ( p=0.006 ) . During stimulation , the retropalatal area enlarged in the anterior – posterior dimension while retrolingual area enlarged in both anterior – posterior and lateral dimensions . During drug-induced sedation endoscopy , the same stimulation increased the retropalatal area by 180.0 % ( p=0.002 ) and retrolingual area by 130.1 % ( p=0.008 ) . Therapy responders had larger retropalatal enlargement with stimulation than nonresponders . UAS increases both the retropalatal and retrolingual areas . This multilevel enlargement may explain reductions of the apnoea – hypopnoea index in selected patients receiving this therapy . Upper-airway stimulation for OSA increases airway dimensions at both the tongue base and the palate Purpose This study aims to compare the effects of a m and ibular advancement device ( MAD ) with continuous positive airway pressure ( CPAP ) treatment for obstructive sleep apnea ( OSA ) on blood pressure ( BP ) , oxidative stress , and heart rate variability ( HRV ) in a r and omized , crossed-over , single-blind , and controlled trial . Methods Twenty-nine moderate-to-severe adult OSA patients underwent  MAD , CPAP , and placebo oral appliance treatment .  Polysomnography , Epworth sleepiness scale , 24-h ambulatory BP monitoring , oxidative stress parameters ( malondialdehyde , catalase , superoxide dismutase , vitamins C , E , B6 , B12 , folate , homocysteine , uric acid ) , and HRV were assessed at baseline and after 1 month of each treatment . Diaries were used to evaluate compliance for devices and a pressure – time meter for CPAP . Results Both active treatments result ed in decreases in apnea and hypopnea index and Epworth sleepiness scale ; CPAP showed a greater effect . Frequency of diastolic BP dipping was higher in the MAD group compared with the CPAP group . A significant drop from baseline levels for catalase activity was observed after MAD . For HRV , there was a significant decrease in total power at night with CPAP and MAD compared with POA , and a decrease in index of sleep autonomic variation with MAD compared with baseline levels . Compliance rates were higher with MAD rather than CPAP . Conclusions Even though CPAP proved to be more effective at attenuating OSA , better compliance with MAD favored the reduction of one of the enzymes which participates in oxidative stress and better autonomic modulation during sleep OBJECTIVE /HYPOTHESIS Selective stimulation of the upper airway is a new therapy for obstructive sleep apnea . The aim of the study was to determine if a selective nerve integrity monitoring ( NIM ) system could aid in precise placement of the cuff electrode in selective upper-airway stimulation . STUDY DESIGN Single-center , prospect i ve clinical trial . METHODS Twenty patients who received a selective upper-airway stimulation system ( Inspire Medical Systems , Maple Grove , MN ) were implanted by using a NIM system . The tongue motions were recorded during surgery and 2 months postoperatively from the transoral view and by transnasal endoscopy . RESULTS All patients exhibited consistent protrusion at tongue front and tongue base . The nerve monitoring system helped to place the cuff electrode around the protrusion and stiffening branches , while excluding the retractor branches of the hypoglossal nerve . CONCLUSION This report demonstrated a novel use of a NIM system to identify the functional separation between inclusion and exclusion branches of the hypoglossal nerve for implantation of a selective upper-airway stimulation system . LEVEL OF EVIDENCE 4 . Laryngoscope , 126:2852 - 2858 , 2016 STUDY OBJECTIVES Investigate the efficacy of a novel nasal expiratory positive airway pressure ( EPAP ) device as a treatment for obstructive sleep apnea ( OSA ) . DESIGN A prospect i ve , multicenter , sham-controlled , parallel-group , r and omized , double-blind clinical trial . SETTING 19 sites including both academic and private sleep disorder centers PATIENTS Obstructive sleep apnea with a pre- study AHI ≥10/hour INTERVENTIONS Treatment with a nasal EPAP device ( N=127 ) or similar appearing sham device ( N=123 ) for 3 months . Polysomnography ( PSG ) was performed on 2 non-consecutive nights ( r and om order : device-on , device-off ) at week 1 and after 3 months of treatment . Analysis of an intention to treat group ( ITT ) ( patients completing week 1 PSGs ) ( EPAP N=119 , sham N=110 ) was performed . MEASUREMENTS AND RESULTS At week 1 , the median AHI value ( device-on versus device-off ) was significantly lower with EPAP ( 5.0 versus 13.8 events/h , P<0.0001 ) but not sham ( 11.6 versus 11.1 events/h , P = NS ) ; the decrease in the AHI ( median ) was greater ( -52.7 % vs. -7.3 % , P<0.0001 ) for the ITT group . At month 3 , the percentage decrease in the AHI was 42.7 % ( EPAP ) and 10.1 % ( sham ) , P<0.0001 . Over 3 months of EPAP  treatment the Epworth Sleepiness Scale decreased ( 9.9 ± 4.7 to 7.2 ± 4.2 , P<0.0001 ) , and the median percentage of reported nights used ( entire night ) was 88.2 % . CONCLUSIONS The nasal EPAP device significantly reduced the AHI and improved subjective daytime sleepiness compared to the sham treatment in patients with mild to severe OSA with excellent adherence . CLINICAL TRIAL INFORMATION REGISTRATION S Clinical Trials.gov . Trial name : R and omized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea ( AERO ) . URL : http://www . clinical trials.gov/ct2/show/NCT00772044?term=Ventus&rank=1 . REGISTRATION NUMBER NCT00772044 Rationale M and ibular advancement devices ( MADs ) are used to treat obstructive sleep apnoea-hypopnoea syndrome ( OSAHS ) but evidence is lacking regarding their clinical and cost-effectiveness in less severe disease . Objectives To compare clinical - and cost-effectiveness of a range of MADs against no treatment in mild to moderate OSAHS . Measurements and methods This open-label , r and omised , controlled , crossover trial was undertaken at a UK sleep centre . Adults with Apnoea-Hypopnoea Index ( AHI ) 5–<30/h and Epworth Sleepiness Scale ( ESS ) score ≥9 underwent 6 weeks of treatment with three non-adjustable MADs : self-moulded ( SleepPro 1 ; SP1 ) ; semi-bespoke ( SleepPro 2 ; SP2 ) ; fully-bespoke MAD ( bMAD ) ; and 4 weeks no treatment . Primary outcome was AHI scored by a polysomnographer blinded to treatment . Secondary outcomes included ESS , quality of life , re source use and cost . Main results 90 patients were r and omised and 83 were analysed . All devices reduced AHI compared with no treatment by 26 % ( 95 % CI 11 % to 38 % , p=0.001 ) for SP1 , 33 % ( 95 % CI 24 % to 41 % ) for SP2 and 36 % ( 95 % CI 24 % to 45 % , p<0.001 ) for bMAD . ESS was 1.51 ( 95 % CI 0.73 to 2.29 , p<0.001 , SP1 ) to 2.37 ( 95 % CI 1.53 to 3.22 , p<0.001 , bMAD ) lower than no treatment ( p<0.001 for all ) . Compliance was lower for SP1 , which was the least preferred treatment at trial exit . All devices were cost-effective compared with no treatment at a £ 20 000/ quality -adjusted life year ( QALY ) threshold . SP2 was the most cost-effective up to £ 39 800/QALY . Conclusions Non-adjustable MADs achieve clinical ly important improvements in mild to moderate OSAHS and are cost-effective . Of those trialled , the semi-bespoke MAD is an appropriate first choice . Trial registration number IS RCT N02309506 OBJECTIVES Endothelial dysfunction has been proposed as a potential mechanism implicated in the pathogenesis of cardiovascular complications of obstructive sleep apnea syndrome ( OSAS ) . This study aim ed to evaluate the microvascular endothelial function ( MVEV ) in OSAS and the impact on MVEF of 2 months of treatment with continuous positive airway pressure ( CPAP ) and m and ibular advancement device ( MAD ) . METHODS Microvascular reactivity was assessed using laser Doppler flowmetry combined with acetylcholine ( Ach ) and sodium nitroprusside ( SNP ) iontophoresis in 24 OSAS patients and 9 control patients . In 12 of the 24 OSAS patients , microvascular reactivity was reassessed after 2 months of CPAP and MAD using a r and omized cross-over design . RESULTS Ach-induced vasodilation was significantly lower in OSAS patients than in matched controls and correlated negatively with apnea hypopnea index ( r=-0.49 , p<0.025 ) and nocturnal oxygen desaturations ( r=-0.63 , p<0.002 ) . Ach-induced vasodilation increased significantly with both CPAP and MAD . The increase in Ach-induced vasodilation under OSAS treatment correlated with the decrease in nocturnal oxygen desaturations ( r=0.48 , p=0.016 ) . CONCLUSION Our study shows an impairment of MVEF in OSAS related to OSAS severity . Both CPAP and MAD treatments were associated with an improvement in MVEF that could contribute to improve cardiovascular outcome in OSAS patients BACKGROUND Snoring is extremely common in the general population and may indicate OSA . However , snoring is not objective ly measured during polysomnography , and no st and ard treatment is available for primary snoring or when snoring is associated with mild forms of OSA . This study determined the effects of oropharyngeal exercises on snoring in minimally symptomatic patients with a primary complaint of snoring and diagnosis of primary snoring or mild to moderate OSA . METHODS Patients were r and omized for 3 months of treatment with nasal dilator strips plus respiratory exercises ( control ) or daily oropharyngeal exercises ( therapy ) . Patients were evaluated at study entry and end by sleep question naires ( Epworth Sleepiness Scale , Pittsburgh Sleep Quality Index ) and full polysomnography with objective measurements of snoring . RESULTS We studied 39 patients ( age , 46 ± 13 years ; BMI , 28.2 ± 3.1 kg/m2 ; apnea-hypopnea index ( AHI ) , 15.3 ± 9.3 events/h ; Epworth Sleepiness Scale , 9.2 ± 4.9 ; Pittsburgh Sleep Quality Index , 6.4 ± 3.3 ) . Control ( n = 20 ) and therapy ( n = 19 ) groups were similar at study entry . One patient from each group dropped out . Intention-to-treat analysis was used . No significant changes occurred in the control group . In contrast , patients r and omized to therapy experienced a significant decrease in the snore index ( snores > 36 dB/h ) , 99.5 ( 49.6 - 221.3 ) vs 48.2 ( 25.5 - 219.2 ) ; P = .017 and total snore index ( total power of snore/h ) , 60.4 ( 21.8 - 220.6 ) vs 31.0 ( 10.1 - 146.5 ) ; P = .033 . CONCLUSIONS Oropharyngeal exercises are effective in reducing objective ly measured snoring and are a possible treatment of a large population suffering from snoring . TRIAL REGISTRY Clinical Trials.gov ; No. : NCT01636856 ; URL : www . clinical trials.gov Objective To describe the 36-month clinical and polysomnography ( PSG ) outcomes in an obstructive sleep apnea ( OSA ) cohort treated with hypoglossal cranial nerve upper airway stimulation ( UAS ) . Study Design A multicenter prospect i ve cohort study . Setting Industry-supported multicenter academic and clinical setting . Subjects Participants ( n = 116 ) at 36 months from a cohort of 126 implanted participants . Methods Participants were enrolled in a prospect i ve phase III trial evaluating the efficacy of UAS for moderated to severe OSA . Prospect i ve outcomes included apnea-hypopnea index , oxygen desaturation index , other PSG measures , self-reported measures of sleepiness , sleep-related quality of life , and snoring . Results Of 126 enrolled participants , 116 ( 92 % ) completed 36-month follow-up evaluation per protocol ; 98 participants additionally agreed to a voluntary 36-month PSG . Self-report daily device usage was 81 % . In the PSG group , 74 % met the a priori definition of success with the primary outcomes of apnea-hypopnea index , reduced from the median value of 28.2 events per hour at baseline to 8.7 and 6.2 at 12 and 36 months , respectively . Similarly , self-reported outcomes improved from baseline to 12 months and were maintained at 36 months . Soft or no snoring reported by bed partner increased from 17 % at baseline to 80 % at 36 months . Serious device-related adverse events were rare , with 1 elective device explantation from 12 to 36 months . Conclusion Long-term 3-year improvements in objective respiratory and subjective quality -of-life outcome measures are maintained . Adverse events are uncommon . UAS is a successful and appropriate long-term treatment for individuals with moderate to severe OSA STUDY OBJECTIVES To examine dose-dependent effects of m and ibular advancement on collapsibility of the passive pharynx and sleep-disordered breathing ( SDB ) . DESIGN Prospect i ve , r and omized study . SETTING University hospital . PATIENTS Thirty-seven adult patients with SDB . INTERVENTIONS Oral appliances with 2- , 4- , and 6-mm advancement of the m and ible . MEASUREMENTS AND RESULTS Overnight oximetry was performed with and without oral appliances . Each 2-mm m and ibular advancement coincided with approximately 20 % improvement in number and severity of nocturnal desaturations . Percentages of patients producing a > 50 % improvement rate of the number of desaturations were 25 % , 48 % , and 65 % with use of oral appliances with 2- , 4- , and 6-mm m and ibular advancement , respectively . Static pharyngeal mechanics were evaluated in six completely paralyzed patients with SDB under general anesthesia with and without the oral appliances . Advancement of m and ibular position was found to produce dose-dependent closing pressure reduction of all pharyngeal segments . Normalization of nocturnal oxygenation was associated with negative closing pressure , especially at the velopharynx . CONCLUSIONS We conclude that improvement of both nocturnal oxygenation and pharyngeal collapsibility significantly depends on the m and ibular position STUDY OBJECTIVES Evaluate the long-term durability of treatment response and safety of a nasal expiratory positive airway pressure ( EPAP ) device used to treat obstructive sleep apnea ( OSA ) . DESIGN A prospect i ve , multicenter , single-arm , open-label extension to a 3-month EPAP vs sham r and omized clinical trial SETTING 13 sites including both academic and private sleep disorder centers PATIENTS OSA patients in the EPAP arm of the EPAP vs sham r and omized study who used the EPAP device ≥ 4 h per night , ≥ 5 nights per week on average during months 1 and 2 of the 3-month trial and had ≥ 50 % reduction in AHI or AHI reduction to < 10 documented by polysomnography , comparing the 3-month device-on PSG to the week-one device-off PSG . INTERVENTIONS Treatment with a nasal EPAP device  ( N = 41 ) for 12 months . Polysomnography ( PSG ) on the patients wearing the device was performed after 12 months of treatment . The month 12 device-on PSG data from the analyzable subject cohort ( N = 34 ) was compared to the week 1 device-off PSG from the EPAP vs sham trial . MEASUREMENTS AND RESULTS Of the 51 patients eligible , 34 were still using the EPAP device at the end of 12 months . Median AHI was reduced from 15.7 to 4.7 events/h ( week 1 device-off versus month 12 device-on ) . The decrease in the AHI ( median ) was 71.3 % ( p < 0.001 ) . The median proportion of sleep time with snoring was reduced by 74.4 % ( p < 0.001 ) . Over 12 months of EPAP  treatment , the Epworth Sleepiness Scale decreased ( 11.1 ± 4.2 to 6.0 ± 3.2 , p < 0.001 ) , and the median percentage of reported nights used ( entire night ) was 89.3 % . CONCLUSIONS Nasal EPAP  significantly reduced the AHI , improved subjective daytime sleepiness and reduced snoring after 12 months of treatment . Long-term adherence to EPAP was excellent in those who had a positive clinical response at month 3 of the EPAP vs sham study . CLINICAL TRIAL REGISTRATION Clinical Trials.gov TRIAL NAME : Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea ( AERO C009E ) . URL : http:// clinical trials.gov/ct2/show/NCT00849043?term=Ventus+Medical&rank=2 . REGISTRATION NUMBER NCT00849043 BACKGROUND Patients with obstructive sleep apnea ( OSA ) exhibit reduced quality of life ( QoL ) due to their daytime symptoms that restricted their social activities . The available data for QoL after treatment with continuous positive airway pressure ( CPAP ) are inconclusive , and few studies have assessed QoL after treatment with speech therapy or other methods that increase the tonus of the upper airway muscles or with a combination of these therapies . The aim of our study was to assess the effect of speech therapy alone or combined with CPAP on QoL in patients with OSA using three different question naires . METHODS Men with OSA were r and omly allocated to four treatment groups : placebo , 24 patients had sham speech therapy ; speech therapy , 27 patients had speech therapy ; CPAP , 27 patients had treatment with CPAP ; and combination , 22 patients had treatment with CPAP and speech therapy . All patients were treated for 3 months . Participants were assessed before and after treatment and after 3 weeks of a washout period using QoL question naires ( Functional Outcomes of Sleep Question naire [ FOSQ ] , World Health Organization Quality of Life [ WHOQoL-Bref ] , and Medical Outcomes Study 36-Item Short-Form Health Survey [ SF-36 ] ) . Additional testing measures included an excessive sleepiness scale ( Epworth sleepiness scale [ ESS ] ) , polysomnography ( PSG ) , and speech therapy assessment . RESULTS A total of 100 men aged 48.1±11.2 ( mean±st and ard deviation ) years had a body mass index ( BMI ) of 27.4±4.9 kg/m(2 ) , an ESS score of 12.7±3.0 , and apnea-hypopnea index ( AHI ) of 30.9±20.6 . After treatment , speech therapy and combination groups showed improvement in the physical domain score of the WHOQoL-Bref and in the functional capacity domain score of the SF-36 . CONCLUSIONS Our results suggest that speech therapy alone as well as in association with CPAP might be an alternative treatment for the improvement of  QoL  in patients with OSA Introduction Obstructive sleep apnoea ( OSA ) is characterised by a loss of neuromuscular tone of the upper airway dilator muscles while asleep . This study investigated the effectiveness of transcutaneous electrical stimulation in patients with OSA . Patients and methods This was a r and omised , sham-controlled crossover trial using transcutaneous electrical stimulation of the upper airway dilator muscles in patients with confirmed OSA . Patients were r and omly assigned to one night of sham stimulation and one night of active treatment . The primary outcome was the 4 % oxygen desaturation index , responders were defined as patients with a reduction > 25 % in the oxygen desaturation index when compared with sham stimulation and /or with an index < 5/hour in the active treatment night . Results In 36 patients ( age mean 50.8 ( SD 11.2 ) years , male/female 30/6 , body mass index median 29.6 ( IQR 26.9–34.9 ) kg/m2 , Epworth Sleepiness Scale 10.5 ( 4.6 ) points , oxygen desaturation index median 25.7 (16.0–49.1)/hour , apnoea-hypopnoea index median 28.1 (19.0–57.0)/hour ) the primary outcome measure improved when comparing sham stimulation ( median 26.9 (17.5–39.5)/hour ) with active treatment ( median 19.5 (11.6–40.0)/hour ; p=0.026 ) , a modest reduction of the mean by 4.1 ( 95 % CI −0.6 to 8.9)/hour . Secondary outcome parameters of patients ' perception indicated that stimulation was well tolerated . Responders ( 47.2 % ) were predominantly from the mild-to-moderate OSA category . In this subgroup , the oxygen desaturation index was reduced by 10.0 ( 95 % CI 3.9 to 16.0)/hour ( p<0.001 ) and the apnoea-hypopnoea index was reduced by 9.1 ( 95 % CI 2.0 to 16.2)/hour ( p=0.004 ) . Conclusion Transcutaneous electrical stimulation of the pharyngeal dilators during a single night in patients with OSA improves upper airway obstruction and is well tolerated . Trial registration number NCT01661712 RATIONALE Upper airway muscle function plays a major role in maintenance of the upper airway patency and contributes to the genesis of obstructive sleep apnea syndrome ( OSAS ) . Preliminary results suggested that oropharyngeal exercises derived from speech therapy may be an effective treatment option for patients with moderate OSAS . OBJECTIVES To determine the impact of oropharyngeal exercises in patients with moderate OSAS . METHODS Thirty-one patients with moderate OSAS were r and omized to 3 months of daily ( approximately 30 min ) sham therapy ( n = 15 , control ) or a set of oropharyngeal exercises ( n = 16 ) , consisting of exercises involving the tongue , soft palate , and lateral pharyngeal wall . MEASUREMENTS AND MAIN RESULTS Anthropometric measurements , snoring frequency ( range 0 - 4 ) , intensity ( 1 - 3 ) , Epworth daytime sleepiness ( 0 - 24 ) and Pittsburgh sleep quality ( 0 - 21 ) question naires , and full polysomnography were performed at baseline and at study conclusion . Body mass index and abdominal circumference of the entire group were 30.3 + /- 3.4 kg/m(2 ) and 101.4 + /- 9.0 cm , respectively , and did not change significantly over the study period . No significant change occurred in the control group in all variables . In contrast , patients r and omized to oropharyngeal exercises had a significant decrease ( P < 0.05 ) in neck circumference ( 39.6 + /- 3.6 vs. 38.5 + /- 4.0 cm ) , snoring frequency ( 4 [ 4 - 4 ] vs. 3 [ 1.5 - 3.5 ] ) , snoring intensity ( 3 [ 3 - 4 ] vs. 1 [ 1 - 2 ] ) , daytime sleepiness ( 14 + /- 5 vs. 8 + /- 6 ) , sleep quality score ( 10.2 + /- 3.7 vs. 6.9 + /- 2.5 ) , and OSAS severity ( apnea-hypopnea index , 22.4 + /- 4.8 vs. 13.7 + /- 8.5 events/h ) . Changes in neck circumference correlated inversely with changes in apnea-hypopnea index ( r = 0.59 ; P < 0.001 ) . CONCLUSIONS Oropharyngeal exercises significantly reduce OSAS severity and symptoms and represent a promising treatment for moderate OSAS . Clinical trial registered with www . clinical trials.gov ( NCT 00660777 ) The objective of this study was to assess variations in the occurrence of temporom and ibular disorders ( TMDs ) and the risk of developing pain and function impairment of the temporom and ibular complex in obstructive sleep apnea syndrome ( OSAS ) patients treated with either an oral appliance ( m and ibular advancement device )  or continuous positive airway pressure ( CPAP )  in a 2-year follow-up study . In addition , we assessed the relationship between the mean m and ibular protrusion and the frequency of wearing the appliance during follow-up with the occurrence of pain and function impairment of the temporom and ibular complex . Fifty-one patients were r and omized to oral appliance therapy and 52 patients to CPAP therapy .  TMDs ( diagnosed according to the Axis I Research Diagnostic Criteria for TMD ) , pain intensity and disability and m and ibular function impairment were recorded at baseline , after 2 months , 1 year and 2 years of therapy . Only in the initial period of treatment the occurrence of pain-related TMDs was considerably higher ( 24 % ) in the oral appliance group compared to CPAP ( 6 % ) . Oral appliance therapy furthermore result ed in more temporom and ibular pain compared to CPAP ( odds ratio 2.33 , 95 % confidence interval ( 1.22–4.43 ) ) . However , there were no limitations in m and ibular function in both groups during the ( entire ) follow-up period . Although generally not serious and of transient nature , oral appliance therapy results in more pain-related TMDs in the initial period of use compared with CPAP therapy . Oral appliance therapy is associated with increased pain in the temporom and ibular complex in the initial period of use . Because of the transient nature , this pain is not a reason to contra-indicate an oral appliance in OSAS patients . Moreover , TMDs and the risk of developing pain and function impairment of the temporom and ibular complex appear limited with long-term oral appliance use The efficacy of currently recommended treatments is uncertain in patients with mild to moderate obstructive sleep apnea ( apnea-hypopnea index [ AHI ] , 5 - 30 ) . A group of 114 sleep clinic patients with an AHI of 5 - 30 have participated in a r and omized controlled crossover trial of 3 months of treatment with each of nasal continuous positive airway pressure ( CPAP ) , a m and ibular advancement splint , and a placebo tablet . Outcomes were sleep fragmentation and hypoxemia , daytime sleepiness , quality of life , neurobehavioral function , and blood pressure . Both active treatments improved sleep outcomes , but positive airway pressure had a greater effect . The quality of life , symptoms , and subjective but not objective sleepiness improved to a similar degree with both treatments ; however , many of the improvements seen in neuropsychologic function and mood were not better than the placebo effect . Some aspects of nocturnal blood pressure were improved with the splint but not with CPAP . This study has shown that although both CPAP and m and ibular advancement splint effectively treated sleep-disordered breathing and sleepiness , the expected response in neurobehavioral function was incomplete . This may be due to the splint having a lesser therapeutic effect and CPAP being poorly tolerated and therefore used less in this patient group BACKGROUND Obstructive sleep apnea is associated with an increased risk of cardiovascular events ; whether treatment with continuous positive airway pressure ( CPAP ) prevents major cardiovascular events is uncertain . METHODS After a 1-week run-in period during which the participants used sham CPAP , we r and omly assigned 2717 eligible adults between 45 and 75 years of age who had moderate-to-severe obstructive sleep apnea and coronary or cerebrovascular disease to receive CPAP treatment plus usual care ( CPAP group ) or usual care alone ( usual-care group ) . The primary composite end point was death from cardiovascular causes , myocardial infa rct ion , stroke , or hospitalization for unstable angina , heart failure , or transient ischemic attack . Secondary end points included other cardiovascular outcomes , health-related quality of life , snoring symptoms , daytime sleepiness , and mood . RESULTS Most of the participants were men who had moderate-to-severe obstructive sleep apnea and minimal sleepiness . In the CPAP group , the mean duration of adherence to  CPAP  therapy was 3.3 hours per night , and the mean apnea-hypopnea index ( the number of apnea or hypopnea events per hour of recording ) decreased from 29.0 events per hour at baseline to 3.7 events per hour during follow-up . After a mean follow-up of 3.7 years , a primary end-point event had occurred in 229 participants in the CPAP group ( 17.0 % ) and in 207 participants in the usual-care group ( 15.4 % ) ( hazard ratio with CPAP , 1.10 ; 95 % confidence interval , 0.91 to 1.32 ; P=0.34 ) . No significant effect on any individual or other composite cardiovascular end point was observed . CPAP significantly reduced snoring and daytime sleepiness and improved health-related quality of life and mood . CONCLUSIONS Therapy with CPAP plus usual care , as compared with usual care alone , did not prevent cardiovascular events in patients with moderate-to-severe obstructive sleep apnea and established cardiovascular disease . ( Funded by the National Health and Medical Research Council of Australia and others ; SAVE Clinical Trials.gov number , NCT00738179 ; Australian New Zeal and Clinical Trials Registry number , ACTRN12608000409370 . ) OBJECTIVE We aim ed to evaluate the impact of a novel noninvasive oral pressure therapy ( OPT ) ( Winx ® , ApniCure ) system on polysomnographic measures of sleep-disordered breathing , sleep architecture , and sleep stability in obstructive sleep apnea ( OSA ) . SUBJECTS AND METHODS A 4-week , multicenter , prospect i ve , open-label , r and omized , crossover , first-night order of control vs treatment , single-arm trial was conducted in five American Academy of Sleep Medicine ( AASM ) - accredited sleep clinics and one research laboratory . Sixty-three subjects ( analysis cohort ) were studied from a screening cohort of 367 subjects . The analysis cohort was 69.8 % men , ages 53.6±8.9 years ( mean±SD ) , body mass index of 32.3±4.5kg/m(2 ) , with mild to severe OSA . At treatment initiation , subjects received r and om assignment to one night with and one without ( control ) treatment , and they were assessed again following 28 nights of  treatment . Breathing and sleep architecture were assessed each night based on blind scoring by a single central ized scorer using AASM criteria . RESULTS Average nightly usage across the take-home period was 6.0±1.4h . There were no severe or serious device-related adverse events ( AEs ) . Median apnea-hypopnea index ( AHI ) was 27.5 events per hour on the control night , 13.4 events per hour on the first treatment night , and 14.8 events per hour after 28days of treatment . A clinical ly significant response ( treatment AHI ⩽10/h and ⩽50 % of control values ) was seen in 20 of the 63 subjects evaluated . Rapid eye movement percentage ( REM% ) was significantly increased , and N1 % , stage shifts to N1 sleep , overall stage shifts , total awakenings , and arousals per hour were all significantly reduced at both treatment nights compared to controls . Mean Epworth sleepiness scale ( ESS ) was significantly reduced from 12.1 to 8.6 ( Cohen d effect size , 0.68 ) in those untreated for two or more weeks prior to OPT study participation and remained unchanged in subjects who directly switched from continuous positive airway pressure ( CPAP ) therapy to OPT . CONCLUSION Clinical ly significant improvements in sleep quality and continuity , AHI , ODI , ESS , and overall clinical status were achieved in an easily identified  subgroup . OPT was safe and well-tolerated and nightly usage was high
Continuous positive airway pressure ( CPAP ) is the st and ard treatment for moderate-to-severe obstructive sleep apnoea ( OSA ) .
However , adherence to CPAP is limited and non-CPAP therapies are frequently explored .
Oral appliance ( OA ) therapy is currently widely used for the treatment of snoring , mild , moderate and severe OSA .
The most commonly used and studied OA consists of a maxillary and m and ibular splint which hold the lower jaw forward during sleep .
Upper airway stimulation augments neural drive by unilaterally stimulating the hypoglossal nerve .
Oropharyngeal exercises consist of a set of isometric and isotonic exercises involving the tongue , soft palate and lateral pharyngeal wall .