Portable Monitoring for Diagnosis and Management of Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

— HomePAP  

Official title:

Portable Monitoring in the Diagnosis and Management of Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642486
• Other study ID #: ASMF 38-PM-07
• Status: Completed
• Phase: N/A
• First received: March 24, 2008
• Last updated: May 25, 2010
• Start date: February 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2008
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: March 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Intermediate to high probability of having OSA based on an adjusted neck circumference > 43 cm (17 inches)

• Presence of excessive daytime sleepiness (Epworth sleepiness scale = 12) Apnea-hypopnea index >= 15 on diagnostic testing to continue in study

Exclusion Criteria:

• Severe chronic insomnia, other condition with < 4 hrs of sleep per night

• Unstable medical conditions

• Major psychiatric diagnosis

• Unable to undergo home testing

• Concerns about unsafe driving

• Severe COPD or restrictive lung disease

• Chronic narcotic use

• Alcohol abuse

• History of cataplexy

• Moderate to severe restless legs syndrome symptoms

• Pre-existing diagnosis of sleep apnea

• Prior experience with positive airway pressure treatment of sleep apnea

• Anticipated upper airway surgery or gastric bypass surgery in 4 months

• Decisional impairment for consenting

• Hypoventilation syndrome, identified in the medical record

• Waking oxygen saturation < 92%

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• Standard polysomnography (PSG)
laboratory-based testing

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (8)

Lead Sponsor	Collaborator
Case Western Reserve University	MetroHealth Medical Center, Northwestern University, The Cleveland Clinic, University Hospital Case Medical Center, University of Minnesota - Clinical and Translational Science Institute, University of Washington, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance of CPAP treatment		from diagnosis to effective treatment	No
Secondary	Compliance with CPAP therapy		1 and 3 month post acceptance	No