Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial. Oral Appliance Therapy versus Nasal Continuous Positive Airway Pressure in Obstructive Sleep Apnea: A Randomized, Placebo-Controlled Trial Mandibular advancement appliance for obstructive sleep apnoea: results of a randomised placebo controlled trial using parallel group design. Randomised study of three non-surgical treatments in mild to moderate obstructive sleep apnoea Obstructive Sleep apnea Therapy Prospective evaluation of an oral appliance in the treatment of obstructive sleep apnea syndrome Mandibular advancement splint titration in obstructive sleep apnoea Effect of vertical dimension on efficacy of oral appliance therapy in obstructive sleep apnea. Continuous positive airway pressure treatment reduces mortality in patients with ischemic stroke and obstructive sleep apnea: a 5-year follow-up study. Oral appliances for obstructive sleep apnea: an evidence-based analysis.
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 ) Background : Previous r and omized controlled trials have addressed the efficacy of m and ibular advancement devices ( MADs ) in the treatment of obstructive sleep apnea ( OSA ) . Their common control condition , nasal continuous positive airway pressure ( nCPAP ) , was frequently found to be superior to MAD therapy . However , in most of these studies , only nCPAP was titrated objective ly but not MAD . To enable an unbiased comparison between both treatment modalities , the MAD should be titrated objective ly as well . Objective : The aim of the present study was to compare the treatment effects of a titrated MAD with those of nCPAP and an intra-oral placebo device . Methods : Sixty-four mild/moderate patients with obstructive sleep apnea ( OSA ; 52.0 ± 9.6 years ) were r and omly assigned to three parallel groups : MAD , nCPAP and placebo device . From all patients , two polysomnographic recordings were obtained at the hospital : one before treatment and one after approximately 6 months of treatment . Results : The change in the apnea-hypopnea index ( ΔAHI ) between baseline and therapy evaluation differed significantly between the three therapy groups ( ANCOVA ; p = 0.000 ) . No differences in the ΔAHI were found between the MAD and nCPAP therapy ( p = 0.092 ) , whereas the changes in AHI in these groups were significantly larger than those in the placebo group ( p = 0.000 and 0.002 , respectively ) . Conclusion : There is no clinical ly relevant difference between MAD and nCPAP in the treatment of mild/moderate OSA when both treatment modalities are titrated objective ly The aim of this trial was to evaluate the efficacy of a m and ibular advancement appliance ( MAA ) for obstructive sleep apnoea ( OSA ) . Ninety-three patients with OSA and a mean apnoea-hypopnoea index ( AHI ) of 34.7 were central ly r and omised into three , parallel groups : ( a ) MAA ; ( b ) m and ibular non-advancement appliance ( MNA ) ; and ( c ) no intervention . The appliances were custom made , in one piece . The MAAs had a mean protrusion of the m and ible of 74 % ( range 64 - 85 % ) . Outcome measures , assessed after continuous use for 4 weeks , were AHI ( polysomnography ) , daytime sleepiness ( Epworth ) and quality of life ( SF-36 ) . Eighty-one patients ( 87 % ) completed the trial . The MAA group achieved mean AHI and Epworth scores significantly lower ( P < 0.001 and P < 0.05 ) than the MNA group and the no-intervention group . No significant differences were found between the MNA group and the no-intervention group . The MAA group had a mean AHI reduction of 14.1 ( 95 % CI 7.4 - 20.8 ) , and a mean Epworth score reduction of 3.3 ( 95 % CI 1.8 - 4.8 ) . Eight MAA patients ( 30 % ) achieved a reduction in AHI > or = 75 % ending with an AHI < 5 , half of them having baseline AHI > 30 . Sensitivity analyses confirmed these results . MAA had a significant beneficial effect on the vitality domain of SF-36 . Four MAA patients ( 14.8 % ) and two MNA patients ( 8 % ) discontinued interventions because of adverse effects . Our conclusion is that MAA has significant beneficial effects on OSA , including cure in some cases of severe OSA . Protrusion of the m and ible is essential for the effect . MNA has no placebo effect . MAA may be a good alternative to CPAP in subsets of OSA patients Background : Patients with mild to moderate obstructive sleep apnoea ( OSA ) may be managed with different treatment options . This study compared the effectiveness of three commonly used non-surgical treatment modalities . Methods : Subjects with mild to moderate OSA were r and omised to one of three treatment groups for 10 weeks : conservative measures ( sleep hygiene ) only , continuous positive airways pressure ( CPAP ) in addition to conservative measures or an oral appliance in addition to conservative measures .  All overweight subjects were referred to a weight-reduction class . OSA  was assessed by polysomnography .  Blood pressure was recorded in the morning and evening in the sleep laboratory . Daytime sleepiness was assessed with the Epworth Sleepiness Scale . Health-related quality of life ( HRQOL ) was assessed with the 36-Item Short-Form Health Survey ( SF-36 ) and Sleep Apnoea Quality of Life Index ( SAQLI ) . Results : 101 subjects with a mean ( SEM ) apnoea – hypopnoea index ( AHI ) of 21.4 ( 1.1 ) were r and omised to one of the three groups . The severity of sleep-disordered breathing was decreased in the CPAP and oral appliance groups compared with the conservative measures group , and the CPAP group was significantly better than the oral appliance group . Relief from sleepiness was significantly better in the CPAP group . CPAP was also better than the oral appliance or conservative measures in improving the “ bodily pain ” domain , and better than conservative measures in improving the “ physical function ” domain of SF-36 . Both CPAP and the oral appliance were more effective than conservative measures in improving the SAQLI , although no difference was detected between the CPAP and oral appliance groups . CPAP and the oral appliance significantly lowered the morning diastolic blood pressure compared with baseline values , but there was no difference in the changes in blood pressure between the groups . There was also a linear relationship between the changes in AHI and body weight . Conclusion : CPAP produced the best improvement in terms of physiological , symptomatic and HRQOL measures , while the oral appliance was slightly less effective . Weight loss , if achieved , result ed in an improvement in sleep parameters , but weight control alone was not uniformly effective In clinical practice , oral appliances are used primarily for obstructive sleep apnea patients who do not respond to continuous positive airway pressure ( CPAP ) therapy . We hypothesized that an oral appliance is not inferior to CPAP in treating obstructive sleep apnea effectively . We r and omly assigned 103 individuals to oral-appliance or CPAP therapy .  Polysomnography after 8–12 weeks indicated that treatment was effective for 39 of 51 persons using the oral appliance ( 76.5 % ) and for 43 of 52 persons using CPAP ( 82.7 % ) . For the difference in effectiveness , a 95 % two-sided confidence interval was calculated . Non-inferiority of oral-appliance therapy  was considered to be established when the lower boundary of this interval exceeded −25 % . The lower boundary of the confidence interval was −21.7 % , indicating that oral-appliance therapy was not inferior to CPAP for effective treatment of obstructive sleep apnea . However , subgroup analysis revealed that oral-appliance therapy was less effective in individuals with severe disease ( apnea-hypopnea index > 30 ) . Since these people could be at particular cardiovascular risk , primary oral-appliance therapy appears to be supported only for those with non-severe apnea The purpose of this study was to investigate the effects of an oral appliance ( OA ) , with and without m and ible advance , in the treatment of  obstructive sleep apnea syndrome ( OSA ) . Twenty-four patients diagnosed with OSA agreed to participate in this study . The patients were treated for 3 months ( with a removable soft elastic silicone positioner customized with thermoplastic silicone and with a 5-mm opening ) . Patients were selected , using a r and omized design , to receive an OA model either with ( 12 patients ) or without advance ( 12 patients ) . Before treatment , a snoring question naire , the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) , the Functional Outcomes of Sleep Question naire ( FOSQ ) , the Epworth Sleepiness Scale ( ESS ) , and polysomnography  were completed . Fifteen subjects completed the protocol ( 13 men , two women ) . With respect to basal values , the m and ible-advanced OA group presented a decrease in the mean apnea – hypopnea index ( AHI ) ( 33.8±4.7 versus 9.6±2.1 ; p<0.01 ) , number of arousals per hour ( 33.8±13.9 versus 16.0±1.5 ; p<0.05 ) , ESS score ( 14.7±5.1 versus 5.1±1.9 ; p<0.05 ) , snoring score ( 15.4±1.9 versus 10.1±3.2 ; p<0.05 ) , and total FOSQ score ( 78.1±22.6 versus 99.3±14.4 ; p<0.05 ) . After treatment , the non-advanced group presented a decrease in the mean AHI ( 24.0±12.2 versus . 11.7±7.9 ; p<0.05 ) . However , no significant differences were found in the number of arousals per hour , ESS score , snoring , and total FOSQ score in the non-advanced group . Neither study group showed significant difference in mean SF36 scores . Oral appliances , especially those that advance the m and ible , offer an effective treatment for OSA Introduction M and ibular advancement splints ( MAS ) allowing self-adjustment may be better tolerated , but the optimum titration protocol needs systematic study . Aim The aims of the study are to assess the effectiveness of a titratable MAS device in consecutive patients with body mass index ( BMI ) < 35 kg/m2 and obstructive sleep apnoea [ OSA , apnoea – hypopnoea index ( AHI ) 10–40/h ] and compare two methods of adjustment  [ self-adjustment  or adjustment after polysomnographic ( PSG ) feedback ] . Material s and methods Twenty-eight patients ( 24 M , mean age 49 years , mean BMI 27.6 kg/m2 ) with symptomatic ( Epworth Sleepiness score > 8/24 , snoring , choking or poor sleep quality ) OSA ( mean AHI 25.7/h , range 10–46/h ) had a MAS set at 70 % maximal protrusion and were r and omised to subjective self-adjustment for 6 weeks ( n = 16 ) or objective adjustment ( n = 12 ; fixed position for 3 weeks , then PSG based feedback at 3 weeks with self-adjustment instructions ) . Primary outcome variable ( AHI ) and OSA symptoms were compared by t tests and chi-squared tests at baseline and after 6 weeks . Resolution of apnoea was defined as AHI < 5/h ; improvement was defined as AHI decreased by > 50 % but still > 5/h . Results The groups had similar baseline demographics , OSA severity and occlusal type . MAS therapy improved or resolved OSA in 20 out of 28 ( 71 % ) and was reportedly used nightly by 91 % of the objective group and 63 % of the subjective group ( p = 0.04 ) . MAS were used all night by 75 % of the objective group and 69 % of the subjective group ( p > 0.05 ) . MAS adjustment following PSG feedback did not lower AHI further from 3 weeks ( baseline 26.5 ± 12.0/h , 3 weeks 15.3 ± 13.5/h p = 0.01 , 6 weeks 11.7 ± 10.0/h , p = 0.11 ) . The overall improvement was similar to that achieved with subjective adjustment ( baseline AHI 25.4 ± 7.4/h , 6 weeks 14.3 ± 10.7/h , p = 0.0002 ) . Symptomatic benefit was reported by both groups . Conclusion In selected patients , titratable MAS improved or resolved OSA in the majority of patients and was well tolerated . PSG-based feedback at 3 weeks allowed objective confirmation of efficacy and increased device use but did not result in greater improvement in AHI or symptoms . Neither titration method was significantly superior for us to provide firm endorsement . However , we recommend a follow-up sleep study to confirm MAS efficacy The aim of this study was to assess the effect of bite opening induced by a m and ibular advancement splint ( MAS ) on efficacy and side effects in the treatment of obstructive sleep apnea . In a r and omized crossover fashion , 23 adult patients received either MAS-1 ( 4 mm of interincisal opening ) or MAS-2 ( 14 mm of interincisal opening )  for 2 weeks , followed by the alternate treatment for 2 weeks , with an intervening 1-week washout . Complete response was defined as a resolution of symptoms and a reduction in apnea/hypopnea index ( AHI ) to less than 5 per hour . Partial response was defined as improved symptoms and a reduction in AHI of 50 % or more , with the AHI remaining at a value of 5 or more per hour . Both MAS-1 and MAS-2 produced similar reductions in mean ( + /- SEM ) AHI from baseline : 21 + /- 2 versus 8 + /- 1/hour and 21 + /- 2 versus 10 + /- 2/hour , respectively ( p < 0.001 ) . Either complete response or partial response occurred in 74 and 61 % of patients with MAS-1 and MAS-2 , respectively . Subjective improvements were reported with both appliances by the majority of patients . Patients preferred MAS-1 ( 78 versus 22 % , p = 0.007 ) . This study suggests that the amount of bite opening induced by MAS does not have a significant impact on treatment efficacy but does have an impact on patient acceptance RATIONALE Obstructive sleep apnea ( OSA ) is an independent risk factor for stroke , but little is known about the role of continuous positive airway pressure ( CPAP ) on mortality in patients with stroke . OBJECTIVES To analyze the independent impact of long-term CPAP treatment on mortality in patients with ischemic stroke . METHODS Prospect i ve observational study in 166 patients with ischemic stroke .  Sleep study was performed in all of them and CPAP treatment was offered in the case of moderate to severe cases . Patients were followed-up for 5 years to analyze the risk of mortality . MEASUREMENTS AND MAIN RESULTS Of 223 patients consecutively admitted for stroke , a sleep study  was performed on 166 of them ( 2 mo after the acute event ) . Thirty-one had an apnea-hypopnea index ( AHI ) of less than 10 ; 39 had an AHI between 10 and 19 , and 96 had an AHI of 20 or greater . CPAP treatment was offered when AHI was 20 or greater . Patients were followed up in our outpatient clinic at 1 , 3 , and 6 months , and for every 6 months thereafter for 5 years ( prospect i ve observational study ) . Mortality data were recorded from our computer data base and official death certificates . The mean age of subjects was 73.3 + /- 11 years ( 59 % males ) , and the mean AHI was 26 ( for all patients with a predominance of obstructive events ) . Patients with an AHI of 20 or greater who did not tolerate CPAP ( n = 68 ) showed an increase adjusted risk of mortality ( hazards ratio [ HR ] , 2.69 ; 95 % confidence interval [ CI ] , 1.32 - 5.61 ) compared with patients with an AHI of less than 20 ( n = 70 ) , and an increased adjusted risk of mortality ( HR , 1.58 ; 95 % CI , 1.01 - 2.49 ; P = 0.04 ) compared with patients with moderate to severe OSA who tolerated CPAP ( n = 28 ) . There were no differences in mortality among patients without OSA , patients with mild disease , and patients who tolerated CPAP . CONCLUSIONS Our results suggest that long-term CPAP treatment in moderate to severe OSA and ischemic stroke is associated with a reduction in excess risk of mortality OBJECTIVE The objective of this review was to determine the clinical effectiveness of oral appliances compared to ' no treatment ' , continuous positive airway pressure ( CPAP ) , or surgery for the management of  obstructive sleep apnea ( OSA ) . CLINICAL NEED CONDITION AND TARGET POPULATION OSA is characterized by repeated occurrences of upper airway collapse and obstruction during sleep . The condition leads to excessive daytime sleepiness , diminished quality of life , and increased risks of accidents , cardiovascular disease and death . In the general population , the prevalence of OSA is estimated to be 4 % in men and 2 % in women . Risk factors for OSA include obesity , male gender , increasing age , alcohol use , sedative use , and a family history of OSA . DESCRIPTION OF ORAL APPLIANCES : ORAL APPLIANCES FOR OSA FALL INTO TWO BROAD CATEGORIES : m and ibular advancement splints ( MAS ) , also known as m and ibular repositioning devices , and tongue repositioning or retaining devices . The aim of MAS devices is to advance the m and ible forward slightly to enlarge the upper airway and prevent it from collapsing . Similarly , tongue repositioning devices suction the tongue forward to prevent it from falling back and obstructing the airway during sleep . The alternatives to oral appliances include continuous positive airway pressure ( CPAP ) devices , surgery , drug therapy , positional devices , and lifestyle modification . CPAP is the gold st and ard of treatment , but despite its effectiveness , compliance rates for CPAP have declined because required systems are noisy and because wearing the mask can be uncomfortable , causing claustrophobia in some users . EVIDENCE -BASED ANALYSIS METHODS RESEARCH QUESTIONS Are oral appliances  effective in improving sleep-disordered breathing in patients with OSA compared to alternative treatments?Are there safety concerns with oral appliances?What is the evidence regarding patient preference , quality of life , and compliance for oral appliances?If effective , are oral appliances  cost effective ? LITERATURE SEARCH A literature search was conducted up to February 2009 . Systematic review s , meta-analyses and r and omized controlled trials ( RCTs ) with more than 20 adults with OSA were eligible for inclusion . The primary outcomes of interest were the Apnea Hypopnea Index ( AHI ) , measures of daytime sleepiness , patient preference , compliance , and adverse events . SUMMARY OF FINDINGS Five systematic review s and 16 RCTs that met the inclusion criteria were identified . The systematic review s consistently concluded that CPAP was more effective than oral appliances at improving sleep disordered breathing , although there may be a niche area for the latter , especially among those with mild OSA as CPAP is difficult to tolerate by some users . Based on the results of the RCTs analyzed for this review , MAS devices are less effective than CPAP when AHI is used as the outcome of interest . MAS devices were shown to decrease AHI levels , but whether this reduction is clinical ly meaningful is uncertain . The Epworth Sleepiness Scale ( ESS ) was not able to achieve statistical significance in comparisons of MAS versus CPAP and MAS versus placebo . Nonetheless , after treatment with either MAS or CPAP , patients seem to be able to achieve normal ESS levels . The ESS has substantial limitations including its subjective nature and low construct validity ( i.e. it is unclear if the scale is an accurate measure of sleepiness ) . Adverse events among patients with MAS  devices in the RCTs were common , but mostly mild and transient . Jaw discomfort was the most commonly reported adverse event . Based on the results of the RCTs , compliance does not seem to be better or worse with MAS or CPAP . Similarly , there is no clear patient preference for MAS or CPAP among the studies reporting preference and satisfaction . KEYWORDS Obstructive sleep apnea , oral appliances , m and ibular advancement splints , tongue repositioning devices
Oral appliances ( OAs ) have demonstrated efficacy in treating  obstructive sleep apnea ( OSA )  , but many different OA devices are available .
The Japanese Academy of Dental Sleep Medicine supported the use of OAs that advanced the m and ible forward and limited mouth opening and suggested an evaluation of their effects in comparison with untreated or CPAP .