Efficacy and tolerability of a custom-made Narval mandibular repositioning device for the treatment of obstructive sleep apnea: ORCADES study 2-year follow-up data

• Published in: Sleep Medicine
• Main Authors: Attali, Valérie, Vecchierini, Marie-Françoise, Collet, Jean-Marc, d'Ortho, Marie-Pia, Goutorbe, Frederic, Kerbrat, Jean-Baptiste, Leger, Damien, Lavergne, Florent, Monaca, Christelle, Monteyrol, Pierre-Jean, Morin, Laurent, Mullens, Eric, Pigearias, Bernard, Martin, Francis, Tordjman, Fabienne, Khemliche, Hauria, Lerousseau, Lionel, Meurice, Jean-Claude
• Other Authors: CHU Pitié-Salpêtrière AP-HP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Neurophysiologie Respiratoire Expérimentale et Clinique (UMRS 1158), Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), Sorbonne Université (SU), Hôpital Hôtel-Dieu Paris, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre du Sommeil et de la Vigilance Paris, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Sorbonne Paris Cité (USPC), CIC - CHU Bichat, Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Diderot - Paris 7 (UPD7), Hôpital Charles Nicolle Rouen, CHU Rouen, Normandie Université (NU)-Normandie Université (NU), Service de neurophysiologie clinique (CHRU Lille), Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille), Hôpital Roger Salengro Lille, Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers La Milétrie )
• Format: Article in Journal/Newspaper
• Language: English
• Published: HAL CCSD 2019
• Subjects: mandibular advancement device; sleep disorder breathing; sleep apnea; [SDV]Life Sciences [q-bio]; narval
• Online Access: https://hal.sorbonne-universite.fr/hal-02297474; https://hal.sorbonne-universite.fr/hal-02297474/document; https://hal.sorbonne-universite.fr/hal-02297474/file/2019%20-%20Efficacy%20and%20tolerability%20of%20a%20custom-made%20Narval%20.pdf; https://doi.org/10.1016/j.sleep.2019.04.021

International audience Objective/BackgroundMandibular repositioning device (MRD) therapy is an alternative to continuous positive airway pressure (CPAP). The ORCADES study is assessing the long-term efficacy and tolerability of MRD therapy in OSAS; 2-year follow-up data are presented.Patients/MethodsOSAS patients who refused or were noncompliant with CPAP were fitted with a custom-made computer-aided design/computer-aided manufacturing (CAD/CAM) bi-block MRD (ResMed, Narval CC™); mandibular advancement was individually titrated. Sleep and respiratory parameters were determined at baseline, 3–6 months, and two years. The primary endpoint was treatment success (percentage of patients achieving a ≥50% reduction in the apnoea-hypopnoea index [AHI]).ResultsOf 315 enrolled patients, 237 remained on MRD treatment at two years, and 197 had follow-up data. The treatment success rate at two years was 67%; AHI <5/h, <10/h and <15/h was achieved in 30%, 56% and 72% of patients, respectively. On multivariate analysis, ≥50% decrease in AHI at 3–6 months and absence of nocturia at 3–6 months were significant predictors of MRD treatment continuation. Adverse events were generally mild, and the majority occurred in the first year of treatment.ConclusionsTwo years’ treatment with an MRD was effective and well tolerated in patients with mild to severe OSAS who refused or were intolerant of CPAP.