摘要

Study Objectives: To test the utility of an integrated clinical pathway for obstructive sleep apnea (OSA) diagnosis and continuous positive airway pressure (CPAP) treatment using portable monitoring devices. %26lt;br%26gt;Design: Randomized, open-label, parallel group, unblinded, multicenter clinical trial comparing home-based, unattended portable monitoring for diagnosis and autotitrating CPAP (autoPAP) compared with in-laboratory polysomnography (PSG) and CPAP titration. %26lt;br%26gt;Setting: Seven American Academy of Sleep Medicine (AASM) accredited sleep centers. %26lt;br%26gt;Participants: Consecutive new referrals, age 18 yr or older with high probability of moderate to severe OSA (apnea-hypopnea index [AHI] %26gt;= 15) identified by clinical algorithm and Epworth Sleepiness Scale (ESS) score %26gt;= 12. %26lt;br%26gt;Interventions: Home-based level 3 testing followed by 1 wk of autoPAP with a fixed pressure CPAP prescription based on the 90% pressure from autotitration of PAP therapy (autoPAP) device (HOME) compared with attended, in-laboratory studies (LAB). %26lt;br%26gt;Measurements: CPAP acceptance, time to treatment, adherence at 1 and 3 mo; changes in ESS, and functional outcomes. %26lt;br%26gt;Results: Of 373 participants, approximately one-half in each study arm remained eligible (AHI %26gt;= 15) to continue in the study. At 3 mo, PAP usage (nightly time at pressure) was 1 hr greater: 4.7 +/- 2.1 hr (HOME) compared with 3.7 +/- 2.4 hr (LAB). Adherence (percentage of night used %26gt;= 4 hr) was 12.6% higher: 62.8 +/- 29.2% compared with 49.4 +/- 36.1% in the HOME versus LAB. Acceptance of PAP therapy, titration pressures, effective titrations, time to treatment, and ESS score change did not differ between arms. %26lt;br%26gt;Conclusions: A home-based strategy for diagnosis and treatment compared with in-laboratory PSG was not inferior in terms of acceptance, adherence, time to treatment, and functional improvements.