NCT00642486

Portable Monitoring for Diagnosis and Management of Sleep Apnea

Portable Monitoring in the Diagnosis and Management of Obstructive Sleep Apnea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 373 (actual)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multi-site project compares compares the efficiency of a home-based portable monitoring strategy to a standard of care sleep laboratory-based strategy for the diagnosis and positive airway pressure treatment of obstructive sleep apnea in adults.

Detailed description

The study is a randomized, parallel group, unblinded, multicenter study that compares two approaches \[home-based, portable monitoring (PM) versus attended, laboratory-based polysomnography (PSG) (Lab)\] in adults, at least 18 years of age, with a moderate to high probability of obstructive sleep apnea (OSA) and who have been referred to sleep medicine specialists at AASM-accredited sleep centers for evaluation and/or management. The study is designed to compare the utility of the two approaches (PM group vs. Lab group) for the diagnosis and management of OSA in adults. Approximately 372 eligible adults will be randomized at screening to either the PM or Lab arm (186 per arm), undergo baseline OSA testing to confirm diagnosis and study eligibility, then receive positive airway pressure (PAP) titration studies to determine the level of pressure needed to treat their OSA. For qualifying participants, the titration study will be lab-based in the Lab group and be home-based using a commercially available portable, automatic PAP device (APAP) in the PM group. All qualifying study participants will have access to study CPAP equipment and supplies to treat their OSA. Primary outcomes (time from diagnosis to effective treatment, patient outcomes, and relative resource utilization) are determined at 1 and 3 months after starting CPAP treatment. Study participants who complete all of their study visits will keep their CPAP machine at the end of the study.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
OTHER	Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex)	portable, home-based using the Embla Embletta X30 system as the diagnostic device and the Respironic REMStar Auto M series with CFlex as the PAP titration device.
OTHER	Standard polysomnography (PSG)	laboratory-based testing

Timeline

• Start date: 2008-02-01
• Primary completion: 2009-07-01
• Completion: 2010-03-01
• First posted: 2008-03-25
• Last updated: 2025-08-05

Locations

1 site across 1 country: United States