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A crossover randomised controlled trial of oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea (TOMADO)

Quinnell, TG, Bennett, M, Jordan, J, Clutterbuck-James, AL, Davies, MG, Smith, IE, Oscroft, N, Pittman, MA, Cameron, M, Chadwick, R , Morrell, MJ, Glover, Matthew J, Fox-Rushby, JA and Sharples, LD (2014) A crossover randomised controlled trial of oral mandibular advancement devices for obstructive sleep apnoea-hypopnoea (TOMADO) Thorax, 69. pp. 938-945.

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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.


To compare clinical- and cost-effectiveness of a range of MADs against no treatment in mild to moderate OSAHS.

Measurements and 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.

Main 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.


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.

Item Type: Article
Divisions : Faculty of Health and Medical Sciences > School of Biosciences and Medicine
Authors :
Quinnell, TG
Bennett, M
Clutterbuck-James, AL
Davies, MG
Smith, IE
Oscroft, N
Pittman, MA
Cameron, M
Chadwick, R
Morrell, MJ
Glover, Matthew
Fox-Rushby, JA
Sharples, LD
Date : 12 September 2014
Funders : National Institute for Health Research (NIHR)
DOI : 10.1136/thoraxjnl-2014-205464
Grant Title : Health Technology Assessment Programme
Uncontrolled Keywords : Science & Technology; Life Sciences & Biomedicine; Respiratory System
Related URLs :
Depositing User : Symplectic Elements
Date Deposited : 16 May 2017 15:35
Last Modified : 30 Apr 2020 13:58

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