Clinical effectiveness and cost-effectiveness results from the randomised controlled Trial of Oral Mandibular Advancement Devices for Obstructive sleep apnoea-hypopnoea (TOMADO) and long-term economic analysis of oral devices and continuous positive airway pressure

• Published in: Health technology assessment (Winchester, England) England), 2014-10, Vol.18 (67), p.1-296
• Main Authors: Sharples, Linda, Glover, Matthew, Clutterbuck-James, Abigail, Bennett, Maxine, Jordan, Jake, Chadwick, Rebecca, Pittman, Marcus, East, Clare, Cameron, Malcolm, Davies, Mike, Oscroft, Nick, Smith, Ian, Morrell, Mary, Fox-Rushby, Julia, Quinnell, Timothy
• Format: Article
• Language: English
• Subjects: Adult; Aged; Cardiovascular Diseases - economics; Cardiovascular Diseases - etiology; Comorbidity; continuous positive airway pressure; Continuous Positive Airway Pressure - economics; Continuous Positive Airway Pressure - instrumentation; Continuous Positive Airway Pressure - methods; Cost-Benefit Analysis; Cross-Over Studies; Disorders of Excessive Somnolence - etiology; economic analysis; England; Female; Humans; Male; Mandibular Advancement - economics; Mandibular Advancement - instrumentation; Mandibular Advancement - methods; mandibular advancement device; Middle Aged; obstructive sleep apnoea-hypopnoea; Patient Compliance - statistics & numerical data; Quality-Adjusted Life Years; randomised controlled trial; Regression Analysis; Risk Assessment; Sleep Apnea, Obstructive - complications; Sleep Apnea, Obstructive - economics; Sleep Apnea, Obstructive - therapy; State Medicine - economics
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/hta18670

Obstructive 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. (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. A 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