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Thorax. 2014 Oct;69(10):938-45. doi: 10.1136/thoraxjnl-2014-205464. Epub 2014 Jul 17.

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

Author information

1
Respiratory Support and Sleep Centre, Papworth Hospital NHS Foundation Trust, Cambridge, UK.
2
Medical Research Council Biostatistics Unit, Institute of Public Health, University Forvie Site, Cambridge, UK.
3
Health Economics Research Group, Brunel University, Uxbridge, Middlesex, UK.
4
Department of Oral and Maxillofacial Surgery, Addenbrooke's NHS Foundation Trust, Cambridge, UK.
5
National Heart & Lung Institute, Royal Brompton Campus, Imperial College, London, UK.
6
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.

Abstract

RATIONALE:

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.

OBJECTIVES:

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.

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.

TRIAL REGISTRATION NUMBER:

ISRCTN02309506.

KEYWORDS:

Sleep apnoea

PMID:
25035126
DOI:
10.1136/thoraxjnl-2014-205464
[Indexed for MEDLINE]

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