Oral mandibular advancement devices (MAD) for obstructive sleep apnoea-hypopnoea (OSAH)

2012 ◽  
Author(s):  
Tim Quinnell
2014 ◽  
Vol 18 (67) ◽  
pp. 1-296 ◽  
Author(s):  
Linda Sharples ◽  
Matthew Glover ◽  
Abigail Clutterbuck-James ◽  
Maxine Bennett ◽  
Jake Jordan ◽  
...  

BackgroundObstructive sleep apnoea–hypopnoea (OSAH) causes excessive daytime sleepiness (EDS), impairs quality of life (QoL) and increases cardiovascular disease and road traffic accident risks. Continuous positive airway pressure (CPAP) treatment is clinically effective but undermined by intolerance, and its cost-effectiveness is borderline in milder cases. Mandibular advancement devices (MADs) are another option, but evidence is lacking regarding their clinical effectiveness and cost-effectiveness in milder disease.Objectives(1) Conduct a randomised controlled trial (RCT) examining the clinical effectiveness and cost-effectiveness of MADs against no treatment in mild to moderate OSAH. (2) Update systematic reviews and an existing health economic decision model with data from the Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea–hypopnoea (TOMADO) and newly published results to better inform long-term clinical effectiveness and cost-effectiveness of MADs and CPAP in mild to moderate OSAH.TOMADOA crossover RCT comparing clinical effectiveness and cost-effectiveness of three MADs: self-moulded [SleepPro 1™ (SP1); Meditas Ltd, Winchester, UK]; semibespoke [SleepPro 2™ (SP2); Meditas Ltd, Winchester, UK]; and fully bespoke [bespoke MAD (bMAD); NHS Oral-Maxillofacial Laboratory, Addenbrooke’s Hospital, Cambridge, UK] against no treatment, in 90 adults with mild to moderate OSAH. All devices improved primary outcome [apnoea–hypopnoea index (AHI)] compared with no treatment: relative risk 0.74 [95% confidence interval (CI) 0.62 to 0.89] for SP1; relative risk 0.67 (95% CI 0.59 to 0.76) for SP2; and relative risk 0.64 (95% CI 0.55 to 0.76) for bMAD (p < 0.001). Differences between MADs were not significant. Sleepiness [as measured by the Epworth Sleepiness Scale (ESS)] was scored 1.51 [95% CI 0.73 to 2.29 (SP1)] to 2.37 [95% CI 1.53 to 3.22 (bMAD)] lower than no treatment (p < 0.001), with SP2 and bMAD significantly better than SP1. All MADs improved disease-specific QoL. Compliance was lower for SP1, which was unpopular at trial exit. At 4 weeks, all devices were cost-effective at £20,000/quality-adjusted life-year (QALY), with SP2 the best value below £39,800/QALY.Meta-analysisA MEDLINE, EMBASE and Science Citation Index search updating two existing systematic reviews (one from November 2006 and the other from June 2008) to August 2013 identified 77 RCTs in adult OSAH patients comparing MAD with conservative management (CM), MADs with CPAP or CPAP with CM. MADs and CPAP significantly improved AHI [MAD −9.3/hour (p < 0.001); CPAP −25.4/hour (p < 0.001)]. Effect difference between CPAP and MADs was 7.0/hour (p < 0.001), favouring CPAP. No trials compared CPAP with MADs in mild OSAH. MAD and CPAP reduced the ESS score similarly [MAD 1.6 (p < 0.001); CPAP 1.6 (p < 0.001)].Long-term cost-effectivenessAn existing model assessed lifetime cost–utility of MAD and CPAP in mild to moderate OSAH, using the revised meta-analysis to update input values. The TOMADO provided utility estimates, mapping ESS score to European Quality of Life-5 Dimensions three-level version for device cost–utility. Using SP2 as the standard device, MADs produced higher mean costs and mean QALYs than CM [incremental cost-effectiveness ratio (ICER) £6687/QALY]. From a willingness to pay (WTP) of £15,367/QALY, CPAP is cost-effective, although the likelihood of MADs (p = 0.48) and CPAP (p = 0.49) being cost-effective is very similar. Both were better than CM, but there was much uncertainty in the choice between CPAP and MAD (at a WTP £20,000/QALY, the probability of being the most cost-effective was 47% for MAD and 52% for CPAP). When SP2 lifespan increased to 18 months, the ICER for CPAP compared with MAD became £44,066. The ICER for SP1 compared with CM was £1552, and for bMAD compared with CM the ICER was £13,836. The ICER for CPAP compared with SP1 was £89,182, but CPAP produced lower mean costs and higher mean QALYs than bMAD. Differential compliance rates for CPAP reduces cost-effectiveness so MADs become less costly and more clinically effective with CPAP compliance 90% of SP2.ConclusionsMandibular advancement devices are clinically effective and cost-effective in mild to moderate OSAH. A semi-bespoke MAD is the appropriate first choice in most patients in the short term. Future work should explore whether or not adjustable MADs give additional clinical and cost benefits. Further data on longer-term cardiovascular risk and its risk factors would reduce uncertainty in the health economic model and improve precision of effectiveness estimates.Trial registrationThis trial is registered as ISRCTN02309506.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 18, No. 67. See the NIHR Journals Library website for further project information.


Thorax ◽  
2019 ◽  
Vol 74 (7) ◽  
pp. 667-674 ◽  
Author(s):  
Jean Louis Pépin ◽  
Nathalie Raymond ◽  
Olivier Lacaze ◽  
Nathalie Aisenberg ◽  
Jérôme Forcioli ◽  
...  

RationaleCustom-made mandibular advancement devices (MADs) are reported as providing higher efficacy rates compared with thermoplastic heat-moulded MADs but at the price of higher costs and treatment delays.ObjectiveTo determine whether a thermoplastic heat-moulded titratable MAD (ONIRIS; ONIRIS SAS, Rueil Malmaison, France) is non-inferior to a custom-made acrylic titratable MAD (TALI; ONIRIS SAS, Rueil Malmaison, France) for obstructive sleep apnoea (OSA).MethodsWe conducted a multicentre, open, randomised controlled trial of patients with OSA refusing or not tolerating continuous positive airway pressure (CPAP). Participants were randomly assigned to a thermoplastic heat-moulded titratable device or a custom-made acrylic device for 2 months with stratification by centre and OSA severity. The non-inferiority primary outcome was a ≥50% reduction in apnoea–hypopnoea index (AHI) or achieving AHI <10 events/hour at 2 months. The non-inferiority margin was preset as a difference between groups of 20% for the primary outcome in the per-protocol analysis.Main resultsOf 198 patients (mean age 51 [SD, 12] years; 138 [72.6%] men; mean body mass index 26 [SD, 2.7] kg/m2; mean AHI 26.6/hour [SD, 10.4]), 100 received TALI and 98 ONIRIS. In per-protocol analysis, the response rate was 51.7% in the TALI group versus 53.6% in the ONIRIS group (absolute difference 1.9%; 90% CI: 11% to 15%, within the non-inferiority margin). Effectiveness was the same for severity, symptoms, quality of life and blood pressure reduction. Patients in ONIRIS group reported more side effects and adherence was slightly better with TALI.ConclusionIn patients with OSA refusing or not tolerating CPAP, the thermoplastic heat-moulded titratable MAD was non-inferior in the short-term to the custom-made acrylic MAD.Trial registration numberNCT02348970.


Thorax ◽  
2014 ◽  
Vol 69 (10) ◽  
pp. 938-945 ◽  
Author(s):  
Timothy G Quinnell ◽  
Maxine Bennett ◽  
Jake Jordan ◽  
Abigail L Clutterbuck-James ◽  
Michael G Davies ◽  
...  

10.3823/2502 ◽  
2017 ◽  
Vol 10 ◽  
Author(s):  
Cauby Maia Chaves Junior ◽  
Cibele Dal Fabbro ◽  
Marco Antonio Cardoso Machado ◽  
Veralice Meireles Sales de Bruin ◽  
Pedro Felipe Carvalhedo de Bruin ◽  
...  

ABSTRACT Introduction: This article is based on Clinical Guidelines for obstructive sleep apnoea (OSA) established by a taskforce coordinated by the Brazilian Sleep Association. Objective: The aim of this article is to evaluate the available scientific evidence regarding the efficacy, adherence and safety of using mandibular advancement devices (MAD) as a therapeutic course for treating obstructive sleep apnoea in adult patients. Method: Active searches were performed in the PubMed/MEDLINE, EMBASE, Scielo/LILACS and Cochrane Library databases.  Methodological aspects were used to rank the levels of evidence according to the criteria of the Centre for Evidence-Based Medicine at Oxford. Results: Mandibular advancement devices offer the best results for patients with primary snoring, upper airway resistance syndrome and mild or moderate OSA (Levels of Evidence I and II).  Patients seem to exhibit greater adherence to oral appliances (MAD) than to continuous positive airway pressure (CPAP) devices, although the latter are more effective in controlling OSA (Level of Evidence I).  The long-term side effects most observed after the use of MADs are related to changes in the mandibular and dental positions (Levels of Evidence I and II).   Conclusion: MAD constitute a therapeutic alternative for OSA and promote favourable results with good efficacy and adherence to treatment.  Side effects can arise in the short, medium or long term.  Patients must be informed about the possible occurrence of these adverse effects, and the orthodontist must be able to manage any side effects that occur due to the use of these devices.


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