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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.

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
ORCADES investigators
Source :
Sleep Medicine. Nov2019, Vol. 63, p64-74. 11p.
Publication Year :
2019

Abstract

<bold>Objective/background: </bold>Mandibular repositioning device (MRD) therapy is an alternative to continuous positive airway pressure (CPAP). The Orkney Complex Disease Study-ORCADES study is assessing the long-term efficacy and tolerability of MRD therapy in obstructive sleep apnoea syndrome (OSAS); two-year follow-up data are presented.<bold>Patients/methods: </bold>OSAS 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]).<bold>Results: </bold>Of 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.<bold>Conclusions: </bold>Two years' treatment with an MRD was effective and well tolerated in patients with mild to severe OSAS who refused or were intolerant of CPAP. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
13899457
Volume :
63
Database :
Academic Search Index
Journal :
Sleep Medicine
Publication Type :
Academic Journal
Accession number :
139676049
Full Text :
https://doi.org/10.1016/j.sleep.2019.04.021