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

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.

Figures

Figure 1

(A) Simplified illustration of the protocol for participants randomized to the lab-based trial arm. (B) Simplified illustration of the protocol for participants randomized to the home-based trial arm. *Decisions for split, repeat, or cross-back studies per protocol for negative or unacceptable studies. AHI, apnea-hypopnea index; PSG, polysomnography; CPAP, continuous positive airway pressure; PAP positive airway pressure; APAP, autotitrating positive airway pressure.

Figure 2

Cohort diagram of participants randomized to the HOME versus LAB management pathways summarizing study flow. CPAP, continuous positive airway pressure, AHI, apnea-hypopnea index.