Sleep Apnea, ObstructiveHomePAPNCT00642486
Portable Monitoring for Diagnosis and Management of Sleep Apnea
A study testing Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex) and Standard polysomnography (PSG) in people with Sleep Apnea, Obstructive, run by Case Western Reserve University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex) and Standard polysomnography (PSG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 373 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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%
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: 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.
Read the 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
- Being tested
- Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex), Standard polysomnography (PSG)
- Keywords
- treatment, positive airway pressure, compliance, cost effectiveness, clinical trial
- Medical subject headings
- Sleep Apnea, Obstructive, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex)Other
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)Other
laboratory-based testing
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | laboratory-based testing Receives: Other: Standard polysomnography (PSG) |
| 2 | Active comparator | home-based testing Receives: Other: Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance of CPAP treatment
Measured: from diagnosis to effective treatment
Secondary outcomes (1)
Compliance with CPAP therapy
Measured: 1 and 3 month post acceptance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center, The Cleveland Clinic, MetroHealth Medical Center, University of Washington, University of Minnesota, Northwestern University, University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Carol L Rosen, MD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642486
- Sponsor's protocol ID
- ASMF 38-PM-07
- Acronym
- HomePAP
- Status last verified
- Mar 2008
- First submitted
- 24 Mar 2008
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 34870587Kim 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.
PubMed 26118558Billings 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.
PubMed 25325491Billings 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.
PubMed 23372269Rosen 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.
PubMed 22654195Billings 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.
PubMed 22131602
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portable Monitoring in the Diagnosis and Management of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00642486
- Acronym / sponsor ID
- HomePAP / ASMF 38-PM-07
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- treatment, positive airway pressure, compliance, cost effectiveness, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center, The Cleveland Clinic, MetroHealth Medical Center, University of Washington, University of Minnesota, Northwestern University, University of Wisconsin, Madison
- Study start
- Feb 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Standard polysomnography (PSG)laboratory-based testing |
| 2 | Active comparator | Other: Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex)home-based testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 2 |
| Standard polysomnography (PSG)laboratory-based testing | Other | 1 |
Primary outcome
Acceptance of CPAP treatment
Time frame: from diagnosis to effective treatment
1 secondary outcome
Compliance with CPAP therapy
Time frame: 1 and 3 month post acceptance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Derived from this study: PubMed 34870587Pascoe 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.
- Derived from this study: PubMed 26118558Kim 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.
- Derived from this study: PubMed 25325491Billings 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.
- Derived from this study: PubMed 23372269Billings 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.
- Derived from this study: PubMed 22654195Rosen 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.
- Derived from this study: PubMed 22131602Billings 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol L Rosen, MD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable (Embla Embletta X30 system and Respironic REMStar Auto M series with CFlex) and Standard polysomnography (PSG) in people with Sleep Apnea, Obstructive, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance of CPAP treatment (time frame: from diagnosis to effective treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00642486, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.