RT Journal Article
SR Electronic
T1 Heat-moulded versus custom-made mandibular advancement devices for obstructive sleep apnoea: a randomised non-inferiority trial
JF Thorax
JO Thorax
FD BMJ Publishing Group Ltd and British Thoracic Society
SP 667
OP 674
DO 10.1136/thoraxjnl-2018-212726
VO 74
IS 7
A1 Jean Louis Pépin
A1 Nathalie Raymond
A1 Olivier Lacaze
A1 Nathalie Aisenberg
A1 Jérôme Forcioli
A1 Eric Bonte
A1 Arnaud Bourdin
A1 Sandrine Launois
A1 Renaud Tamisier
A1 Nicolas Molinari
YR 2019
UL http://thorax.bmj.com/content/74/7/667.abstract
AB Rationale Custom-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.Objective To 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).Methods We 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 results Of 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.Conclusion In 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 number NCT02348970.