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Original article
Heat-moulded versus custom-made mandibular advancement devices for obstructive sleep apnoea: a randomised non-inferiority trial
  1. Jean Louis Pépin1,2,
  2. Nathalie Raymond3,
  3. Olivier Lacaze4,
  4. Nathalie Aisenberg5,
  5. Jérôme Forcioli6,
  6. Eric Bonte7,
  7. Arnaud Bourdin8,
  8. Sandrine Launois9,10,
  9. Renaud Tamisier9,10,
  10. Nicolas Molinari11
  1. 1 HP2 (Hypoxia Pathopysiologies) Laboratory, Universite Grenoble Alpes, Saint-Martin-d'Heres 38400, France
  2. 2 Rééducation et Physiologie, Pôle Locomoteur, Grenoble Alpes University Hospital (CHU), Grenoble, France
  3. 3 Sleep Apnoea Centre, New Bel-Air Clinic, Bordeaux, France
  4. 4 Perpignan Sleep Medicine Practice, Perpignan, France
  5. 5 Les Pavillons sous Bois ENT Practice, Les Pavillons sous Bois, France
  6. 6 Ear, Nose and Throat Department, New Bel-Air Clinic, Bordeaux, France
  7. 7 Odontology Department, Hôpital Bretonneau, AP-HP, Paris, French Polynesia
  8. 8 Department of Pneumology, CHRU Montpellier, Montpellier, France
  9. 9 HP2 (Hypoxia Pathopysiologies) Laboratory, INSERM U1042 Unit, University Grenoble Alpes, Grenoble, France
  10. 10 EFCR (cardio-respiratory function explorations) Laboratory, Pole Thorax and Vessels, Grenoble Alpes University Hospital (CHU), Grenoble, France
  11. 11 Medical Information, CHRU Montpellier, UMR 729 MISTEA, University of Montpellier I, Montpellier, France
  1. Correspondence to Professor Jean Louis Pépin, Universite Grenoble Alpes, Saint-Martin-d'Heres, France; jpepin{at}chu-grenoble.fr

Abstract

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.

  • obstructive sleep apnoea
  • treatment
  • mandibular advancement device
  • heat-moulded
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Footnotes

  • JLP and NR contributed equally.

  • Contributors JLP reviewed the literature, designed the study, interpreted the results, wrote and revised the article and approved the submitted version. NR reviewed the literature, designed the study, included patients and collected data, interpreted the results, revised the manuscript and approved the submitted version. OL included patients and collected data, participated in interpreting the results, revised the manuscript and approved the submitted version. AB included patients and collected data, participated in interpreting the results, revised the manuscript and approved the submitted version. JF included patients and collected data, participated in interpreting the results, revised the manuscript and approved the submitted version. EB included patients and collected data, participated in interpreting the results, revised the manuscript and approved the submitted version. AB included patients and collected data, participated in interpreting the results, revised the manuscript and approved the submitted version. SL included patients and collected data, participated in interpreting the results, revised the manuscript and approved the submitted version. RT reviewed the literature, designed the study, included patients and collected data, interpreted the results, revised the manuscript and approved the submitted version. NM reviewed the literature, designed the study, included patients and collected data, interpreted the results, critically revised the article and approved the submitted version.

  • Funding This study was funded by ONIRIS (France). Data collection, quality control, management and analysis of the data were performed by the contract research organisation Euraxi (France). This work was also supported by the French National Research Agency (Agence Nationale de la Recherche) in the framework of the 'Investissements d’avenir' program (ANR-15-IDEX-02). The funding sources had no role in the study design, realisation, analyses, data interpretation, in writing the manuscript or in the decision to submit it for publication.

  • Competing interests Drs. Pépin and Raymond received honoraria from ONIRIS for participation in the steering committee, participation in the study and travel expenses to present the results at meetings; Dr Molinari received honoraria for participation in the steering committee and participation in the study; Dr Forcioli received travel expenses to present the results at meetings. Investigators’ institutions (for JLP, NR, OL, NA, JF, EB, AB, SL, RT and NM) were remunerated for study visits by ONIRIS.

  • Patient consent for publication Not Required

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement De-identified participant data on baseline characteristics and study outcomes will be shared for justified clinical research purposes only, on written request to the study sponsor: Mr Thibault Vincent ONIRIS France (thibault.vincent@oniris-ronflement.fr). The data will be available after publication of the article describing and analysing it. Access will be for clinical researchers affiliated to a recognised university, clinical research centre or hospital, for the purpose of meta-analyses, etc.

  • Executive steering committee Nathalie Raymond (Principal Investigator), Jean Louis Pépin and Nicolas Molinari (Scientific Advisors). The scientific Steering Committee designed the study and was responsible for its clinical and scientific conduct, and publication of the results. The Steering Committee and in particular first and last authors had full access to all of the data and take responsibility for the integrity and accuracy of the data analysis.

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