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VOLUME 35, ISSUE 06

HOME VERSUS LABORATORY DIAGNOSIS AND TREATMENT OF OSA
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

http://dx.doi.org/10.5665/sleep.1870

Carol L. Rosen, MD1; Dennis Auckley, MD2; Ruth Benca, MD3; Nancy Foldvary-Schaefer, DO4; Conrad Iber, MD5; Vishesh Kapur, MD6; Michael Rueschman, MPH7; Phyllis Zee, MD8; Susan Redline, MD9

1University Hospitals-Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH; 2MetroHealth Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH; 3University of Wisconsin, Madison, WI; 4Cleveland Clinic, Case Western Reserve University, Cleveland, OH; 5Hennepin County Medical Center, University of Minnesota, Minneapolis, MN; 6Harborview Medical Center, University of Washington, Seattle, WA; 7Brigham and Women's Hospital, Boston, MA; 8Northwestern University, Feinberg School of Medicine, Chicago, IL; 9Brigham and Women's Hospital and Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA



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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.

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.

Setting:

Seven American Academy of Sleep Medicine (AASM) accredited sleep centers.

Participants:

Consecutive 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.

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).

Measurements:

CPAP acceptance, time to treatment, adherence at 1 and 3 mo; changes in ESS, and functional outcomes.

Results:

Of 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.

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.

Trial Registration:

http://www.ClinicalTrials.gov; Identifier: NCT: 00642486.

Citation:

Rosen CL; Auckley D; Benca R; Foldvary-Schaefer N; Iber C; Kapur V; Rueschman M; Zee P; Redline S. 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. SLEEP 2012;35(6):757-767.

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