• Sleep · Jun 2012

    Randomized Controlled Trial Multicenter Study

    A multisite randomized trial of portable sleep studies and positive airway pressure autotitration versus laboratory-based polysomnography for the diagnosis and treatment of obstructive sleep apnea: the HomePAP study.

    • Carol L Rosen, Dennis Auckley, Ruth Benca, Nancy Foldvary-Schaefer, Conrad Iber, Vishesh Kapur, Michael Rueschman, Phyllis Zee, and Susan Redline.
    • University Hospitals-Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA. carol.rosen@case.edu
    • Sleep. 2012 Jun 1;35(6):757-67.

    Study ObjectivesTo 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.DesignRandomized, 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.SettingSeven American Academy of Sleep Medicine (AASM) accredited sleep centers.ParticipantsConsecutive new referrals, age 18 yr or older with high probability of moderate to severe OSA (apnea-hypopnea index [AHI] ≥ 15) identified by clinical algorithm and Epworth Sleepiness Scale (ESS) score ≥ 12.InterventionsHome-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).MeasurementsCPAP acceptance, time to treatment, adherence at 1 and 3 mo; changes in ESS, and functional outcomes.ResultsOf 373 participants, approximately one-half in each study arm remained eligible (AHI ≥ 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 ≥ 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.ConclusionsA 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.Trial Registrationhttp://www.ClinicalTrials.gov; Identifier: NCT: 00642486.

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