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Effect of continuous positive airway pressure versus placebo continuous positive airway pressure on sleep quality in obstructive sleep apnea
Loredo JS, Ancoli-Israel S, Dimsdale JE
Chest 1999 Dec;116(6):1545-1549
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: No; 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*

STUDY OBJECTIVES: Continuous positive airway pressure (CPAP) therapy has become the treatment of choice for obstructive sleep apnea (OSA). However, the efficacy of CPAP therapy has not been evaluated against a suitable control. We investigated the effectiveness of CPAP therapy in improving sleep quality in patients with OSA. We hypothesized that CPAP improves sleep quality. PATIENTS: Forty-eight CPAP-naive OSA patients were evaluated. None were receiving antihypertensive-medications, and none had major medical illnesses. DESIGN: Patients were randomized to receive either CPAP or placebo CPAP (CPAP at an ineffective pressure) for 7 days in a double-blind fashion. Forty-one patients completed the protocol. Sleep quality variables, arousals, sleep arterial oxygen saturation (Sao2), and respiratory disturbance index (RDI) were assessed at baseline, after 1 day of treatment, and after 7 days of treatment. Repeated measures analysis of variance was used to evaluate the effects of treatment, time, and the interaction of the two. RESULTS: As expected, CPAP lowered RDI and number of arousals, and increased Sao2 overtime (p = 0.001). Contrary to expectations, both CPAP and placebo CPAP had comparable effects on sleep quality as, assessed by, sleep architecture, sleep efficiency, total sleep time, and wake after sleep onset time. CONCLUSIONS: This study confirms the effectiveness of CPAP in lowering the number of arousals and the RDI, and in raising Sao2. However, our data suggest that short-term CPAP is no different than placebo in improving sleep architecture. Further evaluation of the effectiveness of CPAP using a suitable placebo CPAP in prospective randomized studies is needed.

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