title: A crossover randomised controlled trial of oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea (TOMADO).
abstract: BACKGROUND
  Mandibular 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.
  
  
  OBJECTIVE
  To compare clinical- and cost-effectiveness of a range of MADs against no treatment in mild to moderate OSAHS.
  
  
  METHODS
  This open-label, randomised, 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, resource use and cost.
  
  
  RESULTS
  90 patients were randomised 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 clinically important improvements in mild to moderate OSAHS and are cost-effective. Of those trialled, the semi-bespoke MAD is an appropriate first choice.
  
  
  BACKGROUND
  ISRCTN02309506.
authors.affiliation: Respiratory Support and Sleep Centre, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
authors.forename: Timothy G
authors.initials: TG
authors.lastname: Quinnell
authors.affiliation: Medical Research Council Biostatistics Unit, Institute of Public Health, University Forvie Site, Cambridge, UK.
authors.forename: Maxine
authors.initials: M
authors.lastname: Bennett
authors.affiliation: Health Economics Research Group, Brunel University, Uxbridge, Middlesex, UK.
authors.forename: Jake
authors.initials: J
authors.lastname: Jordan
authors.affiliation: Respiratory Support and Sleep Centre, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
authors.forename: Abigail L
authors.initials: AL
authors.lastname: Clutterbuck-James
authors.affiliation: Respiratory Support and Sleep Centre, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
authors.forename: Michael G
authors.initials: MG
authors.lastname: Davies
authors.affiliation: Respiratory Support and Sleep Centre, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
authors.forename: Ian E
authors.initials: IE
authors.lastname: Smith
authors.affiliation: Respiratory Support and Sleep Centre, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Oscroft
authors.affiliation: Respiratory Support and Sleep Centre, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
authors.forename: Marcus A
authors.initials: MA
authors.lastname: Pittman
authors.affiliation: Department of Oral and Maxillofacial Surgery, Addenbrooke's NHS Foundation Trust, Cambridge, UK.
authors.forename: Malcolm
authors.initials: M
authors.lastname: Cameron
authors.affiliation: Respiratory Support and Sleep Centre, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Chadwick
authors.affiliation: National Heart & Lung Institute, Royal Brompton Campus, Imperial College, London, UK.
authors.forename: Mary J
authors.initials: MJ
authors.lastname: Morrell
authors.affiliation: Health Economics Research Group, Brunel University, Uxbridge, Middlesex, UK.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Glover
authors.affiliation: Health Economics Research Group, Brunel University, Uxbridge, Middlesex, UK.
authors.forename: Julia A
authors.initials: JA
authors.lastname: Fox-Rushby
authors.affiliation: Respiratory Support and Sleep Centre, Papworth Hospital NHS Foundation Trust, Cambridge, UK Medical Research Council Biostatistics Unit, Institute of Public Health, University Forvie Site, Cambridge, UK Clinical Trials Research Unit, University of Leeds, Leeds, UK.
authors.forename: Linda D
authors.initials: LD
authors.lastname: Sharples
mesh_terms: D000328:Adult; D000368:Aged; D003362:Cost-Benefit Analysis; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D019186:Mandibular Advancement / Q000191:economics / Q000295:instrumentation*; D008875:Middle Aged; D017286:Polysomnography; D011788:Quality of Life; D012189:Retrospective Studies; D012720:Severity of Illness Index; D012890:Sleep / Q000502:physiology*; D020181:Sleep Apnea, Obstructive / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D016896:Treatment Outcome
keywords: Sleep apnoea