A Prospective Randomized Study Comparing Two Different Degrees of Mandibular Advancement with a Dental Appliance in Treatment of Severe Obstructive Sleep Apnea Oral appliance therapy improves symptoms in obstructive sleep apnea: a randomized, controlled trial. Treatment of obstructive sleep apnea using a custom-made titratable duobloc oral appliance: a prospective clinical study Long-term oral appliance therapy in obstructive sleep apnea syndrome: a controlled study on dental side effects Effect of oral appliance therapy on neurobehavioral functioning in obstructive sleep apnea: a randomized controlled trial. A combination appliance for obstructive sleep apnea: the effectiveness of mandibular advancement and tongue retention. Accidents in obstructive sleep apnea patients treated with nasal continuous positive airway pressure: a prospective study. The Working Group ANTADIR, Paris and CRESGE, Lille, France. Association Nationale de Traitement à Domicile des Insuffisants Respiratoires. The effect of a mandibular advancement device on apneas and sleep in patients with obstructive sleep apnea. Nasopharyngoscopic evaluation of oral appliance therapy for obstructive sleep apnoea A short-term controlled trial of an adjustable oral appliance for the treatment of mild to moderate obstructive sleep apnoea. A crossover study comparing the efficacy of continuous positive airway pressure with anterior mandibular positioning devices on patients with obstructive sleep apnea. The effect of a mandibular advancement splint on electromyographic activity of the submental and masseter muscles in patients with obstructive sleep apnea. A randomized prospective long-term study of two oral appliances for sleep apnoea treatment. Effects of an oral appliance with different mandibular protrusion positions at a constant vertical dimension on obstructive sleep apnea Effects of a Mandibular Protruding Device on the Sleep of Patients with Obstructive Sleep Apnea and Snoring Problems: A 2-Year Follow-Up A randomised titrated crossover study comparing two oral appliances in the treatment for mild to moderate obstructive sleep apnoea/hypopnoea syndrome. A comparison of the Twin Block and Herbst mandibular advancement splints in the treatment of patients with obstructive sleep apnoea: a prospective study. Adjustable thermoplastic mandibular advancement device for obstructive sleep apnea: outcomes and practicability. The effects of 1-year treatment with a herbst mandibular advancement splint on obstructive sleep apnea, oxidative stress, and endothelial function. Efficacy of an oral appliance for the treatment of obstructive sleep apnea. Evidence of the effectiveness of continuous positive airway pressure in the treatment of sleep apnea/hypopnea syndrome. Comparison of a custom-made and a thermoplastic oral appliance for the treatment of mild sleep apnea. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
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 The aim of this study was to evaluate the effect of a m and ibular advancement splint ( MAS ) on daytime sleepiness and a range of other symptoms in obstructive sleep apnea ( OSA ) .  Using a r and omized crossover design , patients received 4 weeks of treatment with MAS and a control device ( inactive oral appliance ) , with an intervening 1-week washout . At the end of each treatment period , patients were reassessed by question naire , polysomnography , and multiple sleep latency test .  Fifty-nine men and 14 women with a mean ( + /- SD ) age of 48 + /- 11 years and proven OSA experienced a significantly improved mean ( + /- SEM ) sleep latency on the multiple sleep latency test ( 10.3 + /- 0.5 versus 9.1 + /- 0.5 minutes , p = 0.01 ) and Epworth sleepiness scale score ( 7 + /- 1 versus 9 + /- 1 , p < 0.0001 ) with the MAS compared with the control device after 4 weeks . The proportion of patients with normal subjective sleepiness was significantly higher with the MAS than with the control device ( 82 versus 62 % , p < 0.01 ) , but this was not so for objective sleepiness ( 48 versus 34 % , p = 0.08 ) . Other OSA symptoms were controlled in significantly more patients with the MAS than with the control device . MAS therapy improves a range of symptoms associated with OSA Purpose This prospect i ve clinical study investigates the efficacy of a specific custom-made titratable m and ibular advancement device ( MAD ) for the treatment of obstructive sleep apnea ( OSA ) . This MAD has attachments in the frontal teeth area that allow for progressive titration of the m and ible . Methods Sixty-one adult OSA patients were included ( age , 46.7 ± 9.0 years ; male/female ratio , 45/16 ; apnea – hypopnea index ( AHI ) , 23.2 ± 15.4 events/h sleep ; body mass index , 27.9 ± 4.1 kg/m² ) . After an adaptation period , titration started based on a protocol of symptomatic benefit or upon reaching the physiological limits of protrusion . As a primary outcome , treatment response was defined as an objective reduction in AHI following MAD treatment of ≥50 % compared to baseline , and treatment success as a reduction in AHI with MAD to less than 5 and 10 events/h sleep . Compliance failure was defined as an inability to continue treatment . Results A statistically significant decrease was observed in AHI , from 23.4 ± 15.7 at baseline to 8.9 ± 8.6 events/h with MAD ( p < 0.01 ) . Treatment response was achieved in 42 out of 61 patients ( 68.8 % ) , whereas 42.6 % met criteria of AHI < 5 and 63.9 % achieved an AHI < 10 events/h sleep , respectively . Four patients ( 6.6 % ) were considered as “ compliance failures . ” Conclusions The present study has evaluated the efficacy of a specific custom-made titratable MAD in terms of sleep apnea reduction 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 STUDY OBJECTIVES This study aim ed to assess the efficacy of a custom-made m and ibular advancement splint for the treatment of obstructive sleep apnea with respect to neuropsychological functioning and mood state . METHODS A r and omized controlled crossover design was used in which 73 participants ( mean age = 48.4 , SD = 11.0 , % men = 80.8 ) with at least 2 symptoms of obstructive sleep apnea and an apnea hypopnea index > or = 10 per hour underwent treatment with both m and ibular advancement splint and an inactive oral device .  Polysomnographic , neuropsychological and self-report measures were conducted at baseline and repeated after each of the two 4-week treatment phases . RESULTS MAS treatment was associated with improvements on the somatic component of the Beck Depression Inventory and the Vigor-Activity and Fatigue-Inertia scales of the Profile of Mood States . While there were no improvements within the neuropsychological domains of attention/working memory , verbal memory , visuospatial or executive functioning , treatment with the m and ibular advancement splint was associated with faster performance on a test of vigilance/psychomotor speed . These changes , however , did not correspond to the improved subjective sleepiness or apnea-hypopnea index during treatment . CONCLUSIONS Treatment with the m and ibular advancement splint results in improvements in self-reported sleepiness , fatigue/energy levels and vigilance/psychomotor speed in patients with obstructive sleep apnea STUDY OBJECTIVES The purpose of this study was to determine if subjects with moderate-to-severe obstructive sleep apnea would experience increasing treatment effect when a tongue retention component was added to a m and ibular repositioning appliance . DESIGN Cohort study . SETTING Sleep clinic . PATIENTS Forty-four sequentially recruited patients with moderate-to-severe obstructive sleep apnea . INTERVENTIONS Subjects were sleep tested at 4 treatment stages of oral appliance therapy . The 4 stages were : 6-mm m and ibular protrusion , 8-mm protrusion , 6-mm protrusion with a tongue retention bulb , and 8-mm protrusion with a tongue retention bulb . MEASUREMENTS AND RESULTS Forty-one of 44 subjects completed the protocol . There was a decrease in mean respiratory disturbance index from 33.5 events/h at baseline to 18.1 events/h at stage 4 ( p = 0.001 ) . Mean Epworth Sleepiness Scale ( ESS ) decreased from 12.3 at baseline to 9.0 at stage 4 ( p = 0.0001 . CONCLUSIONS A combined approach utilizing both m and ibular protrusion and tongue retention can provide effective treatment for moderate-to-severe obstructive sleep apnea . The addition of a tongue bulb may provide further treatment effect when m and ibular protrusion is limited . Appliance design s that allow for convenient combination therapy need to be developed for this purpose Many studies have shown a relationship between obstructive sleep apnea ( OSA ) and accidents , but to our knowledge , none have investigated prospect ively the effects of treatment with nasal continuous positive airway pressure ( CPAP ) . CPAP was proposed to 973 patients , of whom 893 patients actually underwent CPAP .  These patients were consecutively invited to enter a prospect i ve follow-up study including a question naire before treatment and after 6 and 12 months of treatment ; 547 patients completed the study ( 153 left the study , and only partial data were available for 193 ) . The baseline question naire included questions concerning accidents in the previous 12 months , asking whether patients had had an accident and , if so , whether they felt that the accident(s ) were related to sleepiness , and whether the patients felt that they had had near-miss accidents due to sleepiness . The question naires at 6 and 12 months included the same questions referring to the previous 6 months ; the accidents reported on each follow-up question naire were cumulated and compared with the accidents during the 1-year period before treatment . The number of patients having an accident decreased with treatment for real accidents ( from 60 to 36 ; p<0.01 ) , as well as for near-miss accidents ( from 151 to 32 ; p<0.01 ) . The average number of accidents per patient also decreased , for real accidents ( from 1.6+/-1.3 to 1.1+/-0.3 ; p<0.01 ) and for near-miss accidents ( from 4.5+/-6.5 to 1.8+/-1.4 ; p<0.01 ) . The cost , in terms of days in hospital related to accidents , decreased from 885 to 84 days . With caution due to the absence of a control group , it is suggested that treatment with CPAP decreases the number of accidents occurring in OSA patients . This result may have important implication s in the evaluation of the cost/benefit ratio when treating OSA patients OBJECTIVE To evaluate the effects of a m and ibular advancement device on  apneas and sleep in mild , moderate , and severe obstructive sleep apnea . DESIGN Prospect i ve study . SUBJECTS Forty-four of 47 patients included . INTERVENTION Individually adjusted m and ibular advancement devices . MEASUREMENTS Polysomnographic sleep recordings for 1 night without the device and 1 night with it , with a median of 1 day and no changes in weight , medication , or sleep position between the recordings . RESULTS The device reduced the median obstructive apnea-hypopnea index from 11 ( range , 7 to 19 ) to 5 ( range , 0 to 17 ) ( p<0.001 ) in 21 patients with mild sleep apnea , from 27 ( range , 20 to 38 ) to 7 ( range , 1 to 19 ) ( p<0.001 ) in 15 patients with moderate sleep apnea , and from 53 ( range , 44 to 66 ) to 14 ( range , 2 to 32 ) ( p<0.05 ) in 8 patients with severe sleep apnea . The arousal index decreased and the sleep stage patterns improved in all severity groups . Twenty-eight of 44 patients were successfully treated with an obstructive apnea-hypopnea index of below 10 and a subjective reduction in snoring . Nine of 16 patients with treatment failure still reported a reduction in snoring . The success rate correlated inversely to the disease severity ( r=-0.41 ; p<0.01 ) . CONCLUSIONS A m and ibular advancement device reduces apneas and improves sleep quality in patients with obstructive sleep apnea , especially in those with mild and moderate disease . A follow-up sleep recording during treatment is necessary because of the risk of silent obstructive apneas without subjective snoring with the device This study aim ed to explore the effect of m and ibular advancement splints ( MAS ) on upper airway anatomy during wakefulness in obstructive sleep apnoea ( OSA ) . Patients commencing treatment for OSA with MAS were recruited . Response to treatment was defined by a ≥50 % reduction in the apnoea/hypopnoea index .  Nasopharyngoscopy was performed in the supine position . Nasopharyngoscopy was performed in 18 responders and 17 nonresponders . M and ibular advancement caused an increase in the calibre of the velopharynx ( mean±sem + 40±10 % ) , with relatively minor changes occurring in the oropharynx and hypopharynx . An increase in cross-sectional area of the velopharynx with m and ibular advancement occurred to a greater extent in responders than nonresponders ( + 56±16 % versus + 22±13 % ; p<0.05 ) . Upper airway collapse during the Müller manoeuvre , relative to the baseline cross-sectional area , was greater in nonresponders than responders in the velopharynx ( -94±4 % versus -69±9 % ; p<0.01 ) and oropharynx ( -37±6 % versus -16±3 % ; p<0.01 ) . When the Müller manoeuvre was performed with m and ibular advancement , airway collapse was greater in nonresponders than responders in the velopharynx ( -80±11 % versus + 9±37 % ; p<0.001 ) , oropharynx ( -36±6 % versus -20±5 % ; p<0.05 ) and hypopharynx ( -64±6 % versus -42±6 % ; p<0.05 ) . These results indicate that velopharyngeal calibre is modified by MAS treatment and this may be useful for predicting treatment response BACKGROUND Although oral appliances are effective in some patients with obstructive sleep apnoea ( OSA ) , they are not universally effective . A novel anterior m and ibular positioner ( AMP ) has been developed with an adjustable hinge that allows progressive advancement of the m and ible . The objective of this prospect i ve crossover study was to compare efficacy , side effects , patient compliance , and preference between AMP and nasal continuous positive airway pressure ( nCPAP ) in patients with symptomatic mild to moderate OSA . METHODS Twenty four patients of mean ( SD ) age 44.0 ( 10.6 ) years were recruited with a mean ( SD ) body mass index of 32.0 ( 8.2 ) kg/m2 , Epworth sleepiness score 10.7 ( 3.4 ) , and apnoea/hypopnoea index 26.8 (11.9)/hour . There was a two week wash-in and a two week wash-out period and two treatment periods ( AMP and nCPAP ) each of four months . Efficacy , side effects , compliance , and preference were evaluated by a question naire and home sleep monitoring . RESULTS One patient dropped out early in the study and three refused to cross over so treatment results are presented on the remaining 20 patients . The apnoea/hypopnoea index ( AHI ) was lower with nasal CPAP 4.2 (2.2)/hour than with the AMP 13.6 (14.5)/hour ( p < 0.01 ) . Eleven of the 20 patients ( 55 % ) who used the AMP were treatment successes ( reduction of AHI to < 10/hour and relief of symptoms ) , one ( 5 % ) was a compliance failure ( unable or unwilling to use the treatment ) , and eight ( 40 % ) were treatment failures ( failure to reduce AHI to < 10/hour and /or failure to relieve symptoms ) . Fourteen of the 20 patients ( 70 % ) who used nCPAP were treatment successes , six ( 30 % ) were compliance failures , and there were no treatment failures . There was greater patient satisfaction with the AMP ( p < 0.01 ) than with nCPAP but no difference in reported side effects or compliance . CONCLUSIONS AMP is an effective treatment in some patients with mild to moderate OSA and is associated with greater patient satisfaction than nCPAP OBJECTIVE This study compared the efficacy of a removable anterior m and ibular positioning ( AMP ) device to continuous positive airway pressure ( CPAP ) in patients with obstructive sleep apnea ( OSA ) using a fully balanced crossover design . DESIGN Twenty-three male subjects with confirmed OSA were recruited from the Technion Sleep Laboratory in Haifa , Israel , from February 18 , 1991 to December 17 , 1992 . Twenty-one of the 23 subjects enrolled completed all aspects of the study . RESULTS The mean apnea-hypopnea index ( AHI ) before treatment was 33.86 + /- 14.30 . The mean AHI decreased with CPAP to 59.50 % , but decreased only 38.91 % with the AMP device . The lowest mean recorded oxygen saturation level for the 21 subjects was 84.30 before treatment , 91.10 after CPAP treatment , and 90.20 after AMP treatment . Sleep data revealed a significant decrease in stage 1 and 2 ( p=0.0088 ) and an increase in rapid eye movement percent ( p=0.0066 ) for both treatments when compared with baseline . Three- to 10-month posttreatment phone interviews showed that 1 subject was not using either device , 1 subject was using CPAP , and 2 subjects were using the AMP device intermittently due to occasional temporom and ibular joint pain symptoms . The remaining 17 subjects were all using the AMP device nightly . The symptoms of excessive daytime sleepiness also decreased significantly by both AMP and CPAP . CONCLUSIONS The AMP device achieved substantial success in most cases , but was less effective than CPAP , especially for the more severe cases . In general , the AMP device was strongly preferred over the CPAP by the subjects of this study PURPOSE The effectiveness of an appliance for the treatment of obstructive sleep apnea ( OSA ) shows inordinate interindividual differences . Also , its therapeutic effects still remain unresolved . This study examined and compared the effects of a m and ibular advancement splint ( MAS ) on the masseter and submental muscles of patients with mild and moderate OSA . MATERIAL S AND METHODS Twenty OSA patients ( 10 mild and 10 moderate ) who refused or did not tolerate nasal continuous positive airway pressure were r and omly selected among individuals whose apnea-hypopnea indices ( AHIs ) were determined at the sleep laboratory of the Department of Chest Diseases , Ege University , before the study . Two polysomnography ( PSG ) sessions were performed and evaluated : the first without an MAS for the first half of the night to determine baseline muscle activity and the second with an MAS for the other half of the night to follow the condition of muscle activity . Electromyograms ( EMGs ) of the sum of the submental musculature and masseter muscle were measured with PSGs . The highest EMG amplitudes of the muscles and their AHIs were recorded before and after use of the appliance . Data were analyzed statistically using a t test . RESULTS After insertion of the MAS device , EMG amplitudes increased significantly in the submental ( P < .05 ) and masseter muscles ( P < .05 ) of both mild and moderate OSA patients . However , the increase in muscle activity in the mild OSA group was significantly different from the moderate OSA group ( P < .05 ) . Accordingly , the mean EMG amplitude during moderate apnea episodes was lower than mild both with and without the appliance . After insertion of the MAS , the mean AHI in both mild and moderate OSA patients decreased significantly from baseline recordings ( P < .05 ) . Patients reported a favorable sleeping pattern and no dislodgement of the appliance during sleep . CONCLUSION The MAS activated the masseter and submental muscles during sleep and prevented the upper airway from collapsing . The prosthetic appliance was useful in the treatment of both mild and moderate OSA syndrome Various types of m and ibular protrusive appliances have revealed different treatment success in mild-to-moderate obstructive sleep apnoea ( OSA ) . The present study compared the long-term effect of two different appliances in the treatment of OSA . A total of 103 patients with OSA were r and omized and treated with an IST((R ) ) or Thornton Anterior Positioner ( TAP ( ) ) appliance . They were followed-up after a short-term treatment period of 6 months and long-term treatment period of over 24 months . Sleep studies in the sleep laboratory were conducted with and without the appliances , and various question naires assessing subjective daytime sleepiness , sleep quality , quality of life and symptom scores were administered at each time interval . Quality of life , sleep quality , sleepiness , symptoms and sleep outcome showed significant improvement in the short-term evaluation with both appliances , but the TAP ( ) appliance revealed a significantly greater effect . After more than 2 years of treatment , sleep outcomes revealed an equal effect with both appliances . The subjective benefits achieved initially lessened significantly . This study illustrates that both the IST((R ) ) and the TAP ( ) appliances are effective therapeutic devices for OSA after a period of over 24 months . Lack of compliance may be due to insufficient improvement in anticipated subjective symptoms and /or a recurrence of symptoms over time The aim of the study was to assess the influence of four m and ibular protrusion positions , at a constant vertical dimension , on  obstructive sleep apnea ( OSA ) . Seventeen OSA patients ( 49.2 ± 8.5 years ) received an adjustable m and ibular advancement device ( MAD ) . The patients underwent four polysomnographic recordings with their MAD in situ at , in r and om order , 0 % , 25 % , 50 % , and 75 % of the maximum protrusion . The mean apnea – hypopnea index ( AHI ) values of the patients differed significantly between the protrusion positions ( P < 0.000 ) . The 25 % protrusion position result ed in a significant reduction of the AHI with respect to the 0 % position , while in the 50 % and 75 % positions , even lower AHI values were found . The number of side effects was larger starting at the 50 % protrusion position . We therefore recommend coming to a weighted compromise between efficacy and side effects by starting a MAD treatment in the 50 % protrusion position Objectives : To evaluate subjective discomfort and somnographic measures of patients with obstructive sleep apnea and snoring problems who had been treated for 2 years with a m and ibular protruding device ( MPD ) . Methods : The study population comprised 65 patients with a pretreatment diagnosis of obstructive sleep apnea ( OSA ) ( n = 44 ) or habitual snoring without apnea ( n = 21 ) . After a baseline medical and somnographic examination , a functional examination of the stomatognathic system , and a question naire focused on sleep-related qualities , each patient received an MPD . Two follow-ups were made 6 months and 2 years after MPD treatment had been initiated , and all initial examinations were repeated . Results : At the 2-year follow-up , significant subjective improvements were registered in 90 % of the patients regarding a reduction of snoring and apneas , in 76 % regarding a reduction in daytime tiredness , and in 84 % regarding an improvement in the quality of the night sleep ( change of ≥ 50 % from baseline data ) . At the 2-year follow-up of the OSA group , the oxygen desaturation index ( ODI ) had dropped significantly from a mean value of 14.7 ( SD , 12.7 ) to 3.1 ( SD , 4.2 ) ( P < 0.001 ) , and the mean SaO2 nadir rose from 78.2 % ( SD , 8.1 ) to 89.0 % ( SD , 4.7 ) ( P < 0.001 ) . Only one of the snorers increased his ODI value ; the others retained their initial healthy values . The OSA patients significantly reduced the amount of time they snored during their sleep . Conclusion : MPD treatment is associated with a significant reduction in subjective complaints such as disturbing snoring , apneas , daytime tiredness , and poor quality of night sleep , and with a significant reduction in ODI values in the OSA group . In addition , favorable 6-month results were unchanged after 2 years The objective of this study was to compare the efficiency of two oral appliances in patients with mild to moderate obstructive sleep apnoea/hypopnoea syndrome ( OSAHS ) by the analysis of objective and subjective evaluations and measurement of upper airway parameter . A r and omised crossover design trial was carried out on 16 patients with OSAHS . Two different types of oral appliances were tested in each patient , a one-piece monoblock and the SILENT NITE ( ® ) ( GlideWell Laboratories , Newport Beach , CA , USA ) , a two-piece appliance . Each oral appliance needed to be worn for two 3-month periods separated by a 2-week wash-out period in between . The objective and subjective efficiency and upper airway parameters associated with the oral appliances were assessed . One-way analysis of variance ( anova ) test was performed to compare the changes in upper airway morphology and the treatment efficiency between the appliances . The monoblock and SILENT NITE ( ® ) ( GlideWell Laboratories ) appliances reduced Apnoea Hypopnoea Index ( AHI ) from 26·38 ± 4·13 to 7·58 ± 2·28 ( P < 0·001 ) and 8·87 ± 2·88 ( P < 0·001 ) , respectively . The monoblock appliance was statistically more efficient in reducing AHI and Apnoea Index ( AI ) than the SILENT NITE ( ® ) ( GlideWell Laboratories ) ( P < 0·05 ) . The scores on Epworth 's Sleepiness Scale ( ESS ) and Snoring Scale ( SS ) were improved significantly by both appliances . The upper airway spaces showed considerable enlargement by both m and ibular advancement appliances ( MAAs ) ( P < 0·05 ) , while no significant differences were found between the two appliances ( P > 0·05 ) . Both MAAs showed good efficacy in the treatment for mild to moderate OSAHS . Use of the monoblock appliance should be considered when patients with OSAHS choose MAA treatment , as it was more efficient in reducing the AHI and AI compared to the two-piece appliance and was preferred by most patients . Long-term efficiency should be evaluated in future prospect i ve studies This prospect i ve , r and omized , crossover study of 16 patients with obstructive sleep apnoea ( OSA ) [ 12 males , four females ; median body mass index ( BMI ) 29.2 kg/m(2 ) ( range 23.8 - 51.1 ) ; median age 44.8 years ( range 24.0 - 68.4 ) ] analysed the efficacy of the Twin Block ( TB ) in relation to the Herbst appliance as a m and ibular advancement splint ( MAS ) . Each subject was fitted with a TB and Herbst MAS in a r and om order with a washout period of 2 weeks between appliances . Once each patient was subjectively happy with the performance of each appliance , question naires and a visual analogue scale ( VAS ) were used to determine differences in snoring , daytime sleepiness , quality of life , side-effects of the appliances and patient preference . All patients underwent overnight domiciliary sleep recordings prior to and after fitting each appliance in order to objective ly assess sleep quality in terms of the apnoea-hypopnoea index ( AHI ) , snoring frequency and arterial oxygen saturation . The results suggested that there was no difference in the treatment performance of the TB and Herbst MAS for AHI ( P = 0.71 ) , snoring frequency ( P = 0.49 ) , arterial blood oxygen saturation ( P = 0.97 ) , quality of life and side-effects . The Herbst MAS proved to be the more effective appliance for reducing daytime sleepiness ( P = 0.04 ) and was the more popular appliance among the patients . Side-effects with both appliances were minor and improved in the longer term . The TB MAS represents a viable alternative to the Herbst MAS in the treatment of patients with OSA OBJECTIVES /HYPOTHESIS To assess outcomes including efficacy , adverse effects , and quality of life ( QOL ) of an adjustable thermoplastic m and ibular advancement device ( AT-MAD ) fitted by an otolaryngologist for obstructive sleep apnea ( OSA ) treatment . STUDY DESIGN Prospect i ve , nonr and omized , before-after study . METHODS Sixty-four adult patients ( 40 men and 24 women ) were recruited . Inclusion criteria were OSA patients who had failed or refused treatment with continuous positive airway pressure and surgery . Exclusion criteria were insufficient teeth , active intraoral disease , and temporom and ibular joint ( TMJ ) disorders . Outcomes were measured using polysomnography , symptom question naires , Epworth Sleepiness Scale ( ESS ) , and Functional Outcomes of Sleep Question naire ( FOSQ ) before treatment and 4 to 6 months thereafter . RESULTS Mean apnea-hypopnea index ( AHI ) and ESS scores decreased from 17.7 ± 14.6 to 7.5 ± 10.9 and from 8.7 ± 4.9 to 6.5 ± 4.4 , respectively , after treatment ( P < .001 ) . Thirty-nine patients ( 60.9 % ) achieved post-treatment AHI of < 5 , with the highest success rate in those with mild OSA ( 75 % ) . FOSQ global scores increased from 16.4 ± 2.8 to 17.7 ± 3.0 ( P < .05 ) , along with most FOSQ subscale scores . Thirty-four patients ( 53.1 % ) regularly used the device for ≥5 nights per week . Adverse effects include TMJ discomfort , dry mouth , and excessive salivation , which were largely tolerable . Only four patients withdrew from the study because of adverse effects . CONCLUSIONS This is the first study in Asians demonstrating that an AT-MAD , if done properly , is a practical short-term treatment of OSA , with good outcomes including improved QOL . Its advantages are its low cost and ready-to-use nature . However , further r and omized controlled trials are required BACKGROUND Obstructive sleep apnea ( OSA ) is associated with endothelial dysfunction . In the current study , we assessed the effect of long-term modified Herbst m and ibular advancement splint ( MAS ) treatment on OSA , oxidative stress markers , and on endothelial function ( EF ) . METHODS A total of 16 subjects participated ( 11 men and 5 women ; mean [ + /- SD ] age , 54.0 + /- 8.3 years ; mean body mass index , 28.0 + /- 3.1 kg/m(2 ) ) , 12 of whom completed the 1-year evaluation .  Apnea severity , levels of oxidative stress markers , and EF were assessed after 3 months and 1 year of receiving treatment . For comparison , 6 untreated patients underwent two evaluations 9 months apart , and 10 non-OSA individuals were assessed once as a reference group . The results are presented as the mean + /- SD . RESULTS The mean apnea-hypopnea index ( AHI ) decreased significantly from 29.7 + /- 18.5 events/h before treatment to 17.7 + /- 11.1 events/h after 3 months of treatment and 19.6 + /- 11.5 events/h after 1 year of treatment ( p < 0.005 for both ) . The mean Epworth sleepiness scale score decreased significantly from 12.4 + /- 6.0 before treatment to 10.2 + /- 6.6 after 3 months of treatment and 7.8 + /- 3.8 after 1 year of treatment ( p < 0.001 for both ) . The mean EF improved significantly from 1.77 + /- 0.4 before treatment to 2.1 + /- 0.4 after 3 months of treatment ( p < 0.05 ) and 2.0 + /- 0.3 after 1 year of treatment ( p = 0.055 ) , which were similar to the values of the reference group . Thiobarbituric acid-reactive substance ( TBARS ) levels decreased from 18.8 + /- 6.2 nmol malondialdehyde (MDA)/mL before treatment to 15.8 + /- 3.9 MDA/mL after 3 months of treatment ( p = 0.09 ) and 15.5 + /- 3.2 nmol MDA/mL after 1 year of treatment ( p < 0.05 ) . There was a correlation between the improvement in AHI and in EF or TBARS levels ( r = 0.55 ; p = 0.05 ) . The untreated control group remained unchanged . CONCLUSIONS The Herbst MAS may be a moderately effective long-term treatment for patients with OSA . EF improved to levels that were not significantly different than reference levels , even though apneic events were not completely eliminated . We think that these data are encouraging and that they justify the performance of larger r and omized controlled studies PURPOSE The aim of this study was to vali date the use of a m and ibular repositioner appliance ( MRA ) to treat obstructive sleep apnea ( OSA ) and primary snoring , comparing polysomnographic and Epworth Sleepiness Scale ( ESS ) data obtained prior to and during MRA treatment . MATERIAL S AND METHODS Sixty-three patients who presented with different degrees of OSA severity or primary snoring were fitted to a PM positioner between 2009 and 2011 . The diagnosis was established by a polysomnogram ( PSG ) prior to treatment and after 6 months to verify the efficacy of MRA therapy . Subjective daytime sleepiness was evaluated by ESS question naire prior to treatment and at the follow-up . RESULTS Patients were divided into primary snoring and OSA groups . For the primary snoring group , PSG variables did not show significant results , except for a decrease in snoring . For the OSA group , the mean apnea-hypopnea index ( AHI ) was reduced from 23.0 ± 11 to 5.3 ± 4.0 and median ESS reduced significantly from 13.0 to 8.5 . Complete response ( AHI < 5 ) was found in 25 ( 40 % ) patients and partial response ( AHI ≤ 10 ) in 27 ( 43 % ) patients . CONCLUSION The findings vali date the efficacy of the adjustable PM positioner for the safe treatment of OSA Continuous positive airway pressure ( CPAP ) is worldwide considered as the st and ard treatment of sleep apnea/hypopnea syndrome ( SAHS ) although studies on the effectiveness of this treatment are limited . The aim of our study was to evaluate the effectiveness of CPAP in improving SAHS-related symptoms , daytime function , perceived health status , and quality of life in patients with moderate to severe SAHS . The effect of conservative treatment ( CT ) measures -sleep hygiene and weight loss- was compared with CT + CPAP . We included 105 consecutive patients ( 13 females , age 53 + /- 10 yr , body mass index [ BMI ] = 32 + /- 6 kg/m2 , apnea/hypopnea index [ AHI ] = 56 + /- 20 , Epworth sleepiness scale [ ESS ] = 12 + /- 5 ) who met our criteria for CPAP treatment . Patients were r and omly allocated in two groups of similar characteristics . Group 1 ( n = 37 ) was asked to improve sleep hygiene and started a weight loss program . Group 2 ( n = 68 ) received , in addition , treatment with CPAP . Both groups were followed through weekly telephone calls and appointments . Sleepiness , other symptoms related to SAHS , daytime function , perceived health status , and quality of life were assessed through question naires at inclusion and after 3 mo of treatment . The relief of sleepiness and other SAHS-related clinical symptoms and improvement in perceived health status was much greater in Group 2 receiving CT + CPAP compared with Group 1 , only receiving CT . The odds of experiencing a treatment response with CPAP + CT compared with CT alone was 6.52 ( odds ratio [ OR ] = 2.51 to 17.6 , 95 % confidence interval [ 95 % CI ] ) . CPAP is currently the treatment of choice . At this time , the indication of CPAP treatment in moderate to severe SAHS is adequately supported RATIONALE The efficacy of immediate adaptation of m and ibular advancement devices made of thermoplastic material as a treatment option for sleep-disordered breathing ( SDB ) has been demonstrated in clinical studies . To date , there have been no studies comparing the efficacy of such prefabricated devices with custom-made devices . OBJECTIVES Our purpose was to compare the efficacy of both types of devices in patients with SDB . METHODS A r and omized controlled cross-over trial , comprising 4 months of treatment with a thermoplastic and a custom-made device , with a 1-month washout interval . MEASUREMENTS AND MAIN RESULTS A total of 35 patients ( 29 males ; age , 49 + /- 9 yr ; apnea-hypopnea index [ AHI ] , 13 + /- 11 events/h ; body mass index , 28 + /- 4 kg/m(2 ) ) completed the protocol . AHI was only reduced with the custom-made device ( P = 0.005 ) . In addition , this device reduced snoring to a greater extent than the thermoplastic device . The success rate was higher with the custom-made device ( 60 vs. 31 % ; P = 0.02 ) . One-third of the patients demonstrated compliance failure with the thermoplastic device , mainly because of insufficient overnight retention . Total failure rate with the thermoplastic device was 69 % , whereas the majority ( 63 % ) of these were successfully treated with the custom-made device . At the end of the study , 82 % of the patients preferred the custom-made device , and 9 % had no preference ( P < 0.0001 ) . CONCLUSIONS In this study , a custom-made device turned out to be more effective than a thermoplastic device in the treatment of SDB . Our results suggest that the thermoplastic device can not be recommended as a therapeutic option nor can it be used as a screening tool to find good c and i date s for m and ibular advancement therapy The CONSORT statement is used worldwide to improve the reporting of r and omised controlled trials . Kenneth Schulz and colleagues describe the latest version , CONSORT 2010 , which up date s the reporting guideline based on new method ological evidence and accumulating experience . To encourage dissemination of the CONSORT 2010 Statement , this article is freely accessible on bmj.com and will also be published in the Lancet , Obstetrics and Gynecology , PLoS Medicine , Annals of Internal Medicine , Open Medicine , Journal of Clinical Epidemiology , BMC Medicine , and Trials
OBJECTIVES /HYPOTHESIS M and ibular advancement devices are an alternative to continuous positive airway pressure for patients with mild or moderate obstructive sleep apnea/hypopnea syndrome ( OSAHS ) .
The main aim of this review was to assess the effectiveness of different devices in treating OSAHS , based on polysomnographic measurements such as the apnea/hypopnea index ( AHI ) and oxygen saturation , and on changes in the upper airway and improvements in the most common symptoms : snoring and somnolence .
Their adverse effects were also noted .