Format

Send to

Choose Destination
Sleep. 2012 Jun 1;35(6):757-67. doi: 10.5665/sleep.1870.

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.

Author information

1
University Hospitals-Case Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA. carol.rosen@case.edu

Abstract

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00642486.

KEYWORDS:

OSA; autotitration; diagnosis; portable monitoring; randomized clinical trial

PMID:
22654195
PMCID:
PMC3353048
DOI:
10.5665/sleep.1870
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Silverchair Information Systems Icon for PubMed Central
Loading ...
Support Center