J Clin Sleep Med. 2021 May 3. doi: 10.5664/jcsm.9308. Online ahead of print.
ABSTRACT
STUDY OBJECTIVES: Mandibular advancement devices (MADs) are an alternative to continuous positive airway pressure (CPAP) for the management of obstructive sleep apnea (OSA). The ORCADES study is investigating the long-term effectiveness of MAD therapy in OSA patients who refused or were intolerant with CPAP. Five-year follow-up data are presented.
METHODS: Data were available in 172/331 patients treated with a custom-made computer-aided design/computer-aided manufacturing bi-block MAD (Narval CCTM; ResMed). The primary endpoint was treatment success (≥50% decrease in apnea-hypopnea index from baseline).
RESULTS: Five-year treatment success rates were 52% overall, and 25%, 52% and 63%, respectively, in patients with mild, moderate or severe OSA. This reflects a decline over time versus 3-6 months (79% overall) and 2 years (68%). Rates declined in all patient subgroups, but to the greatest extent in mild OSA patients. The slight worsening of respiratory parameters over time was not associated with any relevant changes in sleepiness and symptoms. Moderate or severe OSA at baseline, treatment success at 3-6 months, and no previous CPAP use were significant independent predictors of 5-year treatment success on multivariate analysis. No new safety signals emerged during long-term follow-up. The proportion of patients using their MAD for ≥4 h/night on ≥4 days/week was 93.3%; 91.3% of patients reported device usage of ≥6 h/night at 5 years. At 5-year follow-up, 96.5% of patients reported that they wanted to continue MAD therapy.
CONCLUSIONS: Long-term MAD therapy remained effective after 5 years in >50% of patients, with good levels of patient satisfaction and adherence.
PMID:34165074 | DOI:10.5664/jcsm.9308
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