Frédéric Gagnadoux1, Xuan-Lan Nguyen2, Marc Le Vaillant3, Pascaline Priou4, Nicole Meslier4, Audrey Eberlein5, Jean-Daniel Kun-Darbois6, Cyril Chaufton2, Bruno Villiers7, Maguy Levy7, Wojciech Trzépizur4, Sandrine Launois8. 1. Université Bretagne Loire, Département de Pneumologie, CHU, Angers, France; Université Bretagne Loire, INSERM UMR 1063, SOPAM, Angers, France. Electronic address: frgagnadoux@chu-angers.fr. 2. Unité de Somnologie et Fonction Respiratoire, Hôpital Saint-Antoine, Paris, France. 3. Centre de Recherche Médecine, Sciences, Santé, Santé mentale, Société, CNRS UMR 8211, INSERM UMR U988-EHESS, Villejuif, France. 4. Université Bretagne Loire, Département de Pneumologie, CHU, Angers, France; Université Bretagne Loire, INSERM UMR 1063, SOPAM, Angers, France. 5. Université Bretagne Loire, Département de Pneumologie, CHU, Angers, France. 6. Université Bretagne Loire, Service de Stomatologie et Chirurgie Maxillo-Faciale, CHU, Angers, France. 7. Service de Stomatologie, Hôpital Saint-Antoine, Paris, France. 8. Unité de Somnologie et Fonction Respiratoire, Hôpital Saint-Antoine, Paris, France; Sorbonne Universités, UPMC Université Paris 06, INSERM UMR_S 1158, Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.
Abstract
BACKGOUND AND OBJECTIVES: The disadvantages of custom-made mandibular advancement devices (MAD) for obstructive sleep apnoea (OSA) therapy are the cost and delay required to manufacture the device. This study aimed to evaluate the efficacy of a titrable, thermoplastic MAD compared to a custom-made MAD for OSA therapy. METHODS: In this prospective nonrandomized study, 158 patients with OSA from two French sleep centers were treated for 6 months with a titrable thermoplastic MAD (n = 86) or a custom-made MAD (n = 72). The primary outcome was the change in sleep-disordered breathing (SDB) severity. RESULTS: After adjustment for baseline values, age, body mass index and study site, no significant intergroup differences were observed between thermoplastic and custom-made MAD for the outcome of apnoea, hypopnoea and oxygen desaturation indices. No between treatment differences were observed for the outcome of subjective sleepiness, symptoms of snoring and fatigue, depressive symptoms, and quality of life. Thermoplastic MAD therapy was associated with higher side effects scores for tooth pain (p < 0.0001) and self-reported occlusal changes (p = 0.0069). Mean (SD) reported compliance was lower in the thermoplastic MAD group than in the custom-made MAD group (6.4 [0.2] vs 7.1 [0.1] h/night; p = 0.035). CONCLUSIONS: This study demonstrates the efficacy of a titrable thermoplastic MAD in reducing SDB and related symptoms in patients with mild to severe OSA. Reported compliance at 6 months was high despite more dental discomfort than with custom-made MAD.
BACKGOUND AND OBJECTIVES: The disadvantages of custom-made mandibular advancement devices (MAD) for obstructive sleep apnoea (OSA) therapy are the cost and delay required to manufacture the device. This study aimed to evaluate the efficacy of a titrable, thermoplastic MAD compared to a custom-made MAD for OSA therapy. METHODS: In this prospective nonrandomized study, 158 patients with OSA from two French sleep centers were treated for 6 months with a titrable thermoplastic MAD (n = 86) or a custom-made MAD (n = 72). The primary outcome was the change in sleep-disordered breathing (SDB) severity. RESULTS: After adjustment for baseline values, age, body mass index and study site, no significant intergroup differences were observed between thermoplastic and custom-made MAD for the outcome of apnoea, hypopnoea and oxygen desaturation indices. No between treatment differences were observed for the outcome of subjective sleepiness, symptoms of snoring and fatigue, depressive symptoms, and quality of life. Thermoplastic MAD therapy was associated with higher side effects scores for tooth pain (p < 0.0001) and self-reported occlusal changes (p = 0.0069). Mean (SD) reported compliance was lower in the thermoplastic MAD group than in the custom-made MAD group (6.4 [0.2] vs 7.1 [0.1] h/night; p = 0.035). CONCLUSIONS: This study demonstrates the efficacy of a titrable thermoplastic MAD in reducing SDB and related symptoms in patients with mild to severe OSA. Reported compliance at 6 months was high despite more dental discomfort than with custom-made MAD.