Sleep · 2025
Patient-reported quality of life outcomes with mandibular advancement versus continuous positive airway pressure: insights from the CRESCENT trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеМногоцентровое исследованиеEquivalence TrialНазвание и аннотация: Перевод пока не подготовлен
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Colpani Juliana Tereza, Ou Yi-Hui, Thakumar Annushiah Vasan, Cheong Crystal S, Loke Weiqiang, Sia Ching-Hui, Teo Yao-Hao, Chan Siew-Pang, Chin Calvin W, Kojodjojo Pipin, Chan Mark Y, Cistulli Peter A, Luo Nan, Lee Chi-Hang
Аннотация
STUDY OBJECTIVES: We compared mandibular advancement device (MAD) versus continuous positive airway pressure (CPAP) on quality-of-life (QoL) in a prespecified analysis of the CRESCENT trial.
METHODS: Two hundred and twenty participants over age 40 with Obstructive sleep apnea (OSA), hypertension, and increased cardiovascular risk from three public hospitals were randomly assigned to MAD or CPAP (1:1). Multi-dimensional QoL questionnaires were administered at baseline, 6 months, and 12 months. Three sleep-related QoL questionnaires: Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and Sleep Apnea Quality of Life Index (SAQLI). Two generic QoL questionnaires: EuroQoL 5-D (EQ-5D) and Short Form 36 Health Survey (SF36).
RESULTS: MAD adherence was 5.5 (3.9-6.9) hours at 6 months and 5.0 (3.3-6.1) hours at 12 months. CPAP adherence was 4.9 (3.3-6.1) hours at 6 months and 4.8 (3.3-5.7) hours at 12 months. Both groups showed improvements in sleep-related QoL. ESS improved at 6 and 12 months (p < .001), with a between-group difference favoring CPAP at 6 months (Δ 1.45 [0.44 to 2.46], p = .005). FOSQ improved at 6 and 12 months (p < .001), with a between-group difference favoring CPAP at 12 months (Δ -0.91 [-1.77 to -0.05], p = .038). SAQLI improved at 6 and 12 months (p < .001) without between-group differences. For generic QoL questionnaires, SF-36 improved in most domains at 6 and 12 months, with the Social Functioning section favoring CPAP at 12 months (p = .013). EQ-5D improved at 12 months, with a trend favoring CPAP (p = .053).
CONCLUSIONS: MAD and CPAP effectively improved sleep-related QoL and some aspects of generic QoL. CPAP improved sleep-related QoL to a greater extent than MAD.
CLINICAL TRIAL NAME: The Cardiosleep Research Program on OSA, Blood Pressure Control and Maladaptive Myocardial Remodeling-Non-inferiority Trial (CRESCENT). URL: https://clinicaltrials.gov/study/NCT04119999?locStr=Singapore&country=Singapore&cond=Obstructive%20Sleep%20Apnea&aggFilters=ages:adult%20older,studyType:int&rank=6TRIAL REGISTRATION: NCT04119999.
METHODS: Two hundred and twenty participants over age 40 with Obstructive sleep apnea (OSA), hypertension, and increased cardiovascular risk from three public hospitals were randomly assigned to MAD or CPAP (1:1). Multi-dimensional QoL questionnaires were administered at baseline, 6 months, and 12 months. Three sleep-related QoL questionnaires: Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire (FOSQ), and Sleep Apnea Quality of Life Index (SAQLI). Two generic QoL questionnaires: EuroQoL 5-D (EQ-5D) and Short Form 36 Health Survey (SF36).
RESULTS: MAD adherence was 5.5 (3.9-6.9) hours at 6 months and 5.0 (3.3-6.1) hours at 12 months. CPAP adherence was 4.9 (3.3-6.1) hours at 6 months and 4.8 (3.3-5.7) hours at 12 months. Both groups showed improvements in sleep-related QoL. ESS improved at 6 and 12 months (p < .001), with a between-group difference favoring CPAP at 6 months (Δ 1.45 [0.44 to 2.46], p = .005). FOSQ improved at 6 and 12 months (p < .001), with a between-group difference favoring CPAP at 12 months (Δ -0.91 [-1.77 to -0.05], p = .038). SAQLI improved at 6 and 12 months (p < .001) without between-group differences. For generic QoL questionnaires, SF-36 improved in most domains at 6 and 12 months, with the Social Functioning section favoring CPAP at 12 months (p = .013). EQ-5D improved at 12 months, with a trend favoring CPAP (p = .053).
CONCLUSIONS: MAD and CPAP effectively improved sleep-related QoL and some aspects of generic QoL. CPAP improved sleep-related QoL to a greater extent than MAD.
CLINICAL TRIAL NAME: The Cardiosleep Research Program on OSA, Blood Pressure Control and Maladaptive Myocardial Remodeling-Non-inferiority Trial (CRESCENT). URL: https://clinicaltrials.gov/study/NCT04119999?locStr=Singapore&country=Singapore&cond=Obstructive%20Sleep%20Apnea&aggFilters=ages:adult%20older,studyType:int&rank=6TRIAL REGISTRATION: NCT04119999.