Portable Monitoring for Diagnosis and Management of Sleep Apnea (HomePAP)
July 31, 2025 updated by: Case Western Reserve University
Portable Monitoring in the Diagnosis and Management of Obstructive Sleep Apnea
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
373
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- University Hospitals Case Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
laboratory-based testing
|
laboratory-based testing
|
|
Active Comparator: 2
home-based testing
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Acceptance of CPAP treatment
Time Frame: from diagnosis to effective treatment
|
from diagnosis to effective treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Compliance with CPAP therapy
Time Frame: 1 and 3 month post acceptance
|
1 and 3 month post acceptance
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Carol L Rosen, MD, Case Western Reserve University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pascoe M, Bena J, Andrews ND, Auckley D, Benca R, Billings ME, Kapur VK, Iber C, Zee PC, Redline S, Rosen CL, Foldvary-Schaefer N. Dose-response relationship between positive airway pressure therapy and excessive daytime sleepiness: the HomePAP study. J Clin Sleep Med. 2022 Apr 1;18(4):1027-1034. doi: 10.5664/jcsm.9792.
- Kim RD, Kapur VK, Redline-Bruch J, Rueschman M, Auckley DH, Benca RM, Foldvary-Schafer NR, Iber C, Zee PC, Rosen CL, Redline S, Ramsey SD. An Economic Evaluation of Home Versus Laboratory-Based Diagnosis of Obstructive Sleep Apnea. Sleep. 2015 Jul 1;38(7):1027-37. doi: 10.5665/sleep.4804.
- Billings ME, Rosen CL, Auckley D, Benca R, Foldvary-Schaefer N, Iber C, Zee PC, Redline S, Kapur VK. Psychometric performance and responsiveness of the functional outcomes of sleep questionnaire and sleep apnea quality of life instrument in a randomized trial: the HomePAP study. Sleep. 2014 Dec 1;37(12):2017-24. doi: 10.5665/sleep.4262.
- Billings ME, Rosen CL, Wang R, Auckley D, Benca R, Foldvary-Schaefer N, Iber C, Zee P, Redline S, Kapur VK. Is the relationship between race and continuous positive airway pressure adherence mediated by sleep duration? Sleep. 2013 Feb 1;36(2):221-7. doi: 10.5665/sleep.2376.
- 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 Jun 1;35(6):757-67. doi: 10.5665/sleep.1870.
- Billings ME, Auckley D, Benca R, Foldvary-Schaefer N, Iber C, Redline S, Rosen CL, Zee P, Kapur VK. Race and residential socioeconomics as predictors of CPAP adherence. Sleep. 2011 Dec 1;34(12):1653-8. doi: 10.5665/sleep.1428.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
March 24, 2008
First Submitted That Met QC Criteria
March 24, 2008
First Posted (Estimated)
March 25, 2008
Study Record Updates
Last Update Posted (Actual)
August 5, 2025
Last Update Submitted That Met QC Criteria
July 31, 2025
Last Verified
March 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASMF 38-PM-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.