Objective: The mandibular advancement appliance (MAA) is now recognized as a first-line therapy option for mild to moderate obstructive sleep apnea syndrome (OSAS). The aim of this follow-up study was to re-assess the long-term efficacy of MAAs provided to patients in a previous comparative study.
Methods: Sixteen subjects had participated in a previous comparative study in which the efficacy and compliance of two MAAs (Klearway - K and Silencer - S) were compared in a randomized cross-over design. At the end of the previous comparative study, subjects selected the MAA they preferred. Nine chose the K and seven the S. Fifteen subjects were available for a follow-up interview and 14 (4 women and 10 men; mean ± SEM: 51.9 ± 1.7 y.o.) agreed to participate in an overnight sleep recording at a hospital sleep laboratory from January to February 2009. The mean time lag between the end of the previous comparative study and the follow-up was 40.9 ± 2.1 months (range of 2.5-4.5 years). Comparisons were made across the three polysomnographic evaluations (PSGE): baseline, the night with the appliance of their choice at the end of the previous comparative study, and the follow-up night. Subjects completed the Epworth sleepiness scale (ESS), the fatigue severity scale (FSS), and a quality of life questionnaire (FOSQ).
Results: At the follow-up, the respiratory disturbance index (RDI) remained significantly lower than baseline (p<0.001). Questionnaire responses revealed that ESS, FSS, and FOSQ remained improved at follow-up (p<0.02). Body mass index (BMI) increased slightly from baseline to follow-up (p<0.05). Diastolic and systolic blood pressure and cardiac rhythm decreased significantly from baseline to follow-up.
Conclusions: The MAAs remained effective in improving RDI, sleepiness, blood pressure, cardiac rhythm, fatigue, sleep quality, and quality of life over a period of 2.5-4.5 years. The rise in BMI is a concern that merits further examination.
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