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A randomized crossover trial of a pressure relief technology (SensAwake) in continuous positive airway pressure to treat obstructive sleep apnea |
Bogan RK, Wells C |
Sleep Disorders 2017 Dec 19;(3978073):Epub |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVES/BACKGROUND: Improving adherence to CPAP devices is crucial to reduce the long-term morbidity associated with OSA. SensAwake is a unique pressure relief technology that aims to promptly reduce the pressure upon sensing irregular respiration indicative of wakefulness. The purpose of this study was to compare adherence and sleep-quality outcomes in patients treated by CPAP with and without SensAwake technology. METHODS: Participants with moderate-to-severe OSA were randomized to use CPAP devices with or without SensAwake (4 weeks) before crossing over. RESULTS: Sixty-five patients completed both arms of the trial. There were no statistically significant differences in CPAP adherence with or without SensAwake over the study period (SensAwake ON 272.67 +/- 17.06 versus SensAwake OFF 289.09 +/- 15.24; p = 0.180). SensAwake reported a significantly lower system leak, 90th percentile leak, and time spent with excessive (> 60 L/min) leak. Subgroup analysis suggested a trend towards improved adherence in patients with moderate-to-severe insomnia when using SensAwake. CONCLUSIONS: Using SensAwake incurred benefit in terms of reduced leaks; however, SensAwake did not improve CPAP adherence or objective sleep quality. Further studies should investigate the accuracy of observed trends towards increased adherence using SensAwake among patients with OSA and insomnia.
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