Obstructive Sleep ApneamPAPNCT06039865
Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP) Trial
A study testing Immediate Intervention in people with Obstructive Sleep Apnea, run by VA Greater Los Angeles Healthcare System at 1 site in United States.
Trial summary
The goal of this clinical trial in adults with obstructive sleep apnea prescribed positive airway pressure therapy is to test the effects of a new patient-facing consumer wearable-based program (that involves provision of a consumer wearable that measures oxygen levels during sleep plus customized weekly reports to… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Immediate Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2023to 21 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prescribed PAP therapy from the sleep center for > 1 week
- Have an active profile in our Center's ResMed AirView or Respironics Care Orchestrator accounts for > 1 week
- Non-adherent with PAP therapy
- Willing to continue using current PAP device for 28 days continuously
- Have an electronic device compatible with the wearable app
Who cannot join
- Diagnosis of heart failure, chronic lung disease, dementia, active substance use disorder
- Use home oxygen
- Unstable medical or psychiatric illness
- Planned non-use of PAP therapy (e.g., waiting for replacement of recalled PAP device)
- Planned surgery or hospitalization during study period
- Planned extensive travel during study period
- History of repeated non-attendance at clinic visits
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System
North Hills, California, 91343
About this study
Official title: Augmenting Obstructive Sleep Apnea Chronic Care Management With Consumer Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy
The goal of this clinical trial in adults with obstructive sleep apnea prescribed positive airway pressure therapy is to test the effects of a new patient-facing consumer wearable-based program (that involves provision of a consumer wearable that measures oxygen levels during sleep plus customized weekly reports to participants). The main question is to learn whether participants' use of positive airway pressure therapy will differ between the participants who receive the new program immediately versus delayed. Participants assigned to the delayed program will receive usual care while waiting for the program to begin.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized to immediate versus waitlist control in a 1:1 ratio.
Our project is at the forefront of consumer wearable research, leveraging the recent capabilities of consumer wearables to provide pulse oximetry data during sleep, to uncover new ways to promote PAP usage among patients with obstructive sleep apnea.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Immediate Intervention, Waitlist control
- Keywords
- Wearable, Pulse oximetry, Sleep apnea, Treatment adherence
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate InterventionBehavioural
Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.
Waitlist controlBehavioural
Participants only receive usual care from the sleep center.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks. Receives: Behavioral: Immediate Intervention |
| Waitlist control | Other | Participants will receive usual care from the sleep center for 6 weeks and then be provided with a consumer wearable to wear for 4 weeks. Receives: Behavioral: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PAP Adherence (Minutes) From Baseline to Post-treatment (T3)
Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3), which was 35 days after randomization.
Measured: 5 weeks
Secondary outcomes (1)
Change in PAP Adherence (Days Used >= 4 Hours) From Baseline to Post-treatment (T3)
Change in the days PAP was used >= 4 hours from baseline (T1) to post-treatment (T3), which occurred 35 days after randomization.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start20 Oct 2023
- Primary completion21 Jan 2025
- Study completion21 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Greater Los Angeles Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- University of California, Los Angeles
- Responsible party
- Principal investigator, Constance Fung, VA Greater Los Angeles Healthcare System
- Investigators
- Constance H. Fung, MD, MSHS, Principal investigator, VA Greater Los Angeles Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039865
- Sponsor's protocol ID
- 20233750
- Acronym
- mPAP
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2023
- Last updated
- 3 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mak S, Ash G, Liang LJ, Der-McLeod E, Ghadimi S, Kewalramani A, Naeem S, Zeidler M, Fung C. Testing a Consumer Wearables Program to Promote the Use of Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 19;13:e60769. doi: 10.2196/60769.
PubMed 39207912
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Obstructive Sleep Apnea Chronic Care Management With Consumer Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy
- ClinicalTrials.gov ID
- NCT06039865
- Acronym / sponsor ID
- mPAP / 20233750
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Wearable, Pulse oximetry, Sleep apnea, Treatment adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- VA Greater Los Angeles Healthcare SystemUS federal agency
- Collaborators
- University of California, Los Angeles
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 21 Jan 2025 (actual)
- First posted
- 15 Sep 2023 (actual)
- Results
- Posted 3 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial in adults with obstructive sleep apnea prescribed positive airway pressure therapy is to test the effects of a new patient-facing consumer wearable-based program (that involves provision of a consumer wearable that measures oxygen levels during sleep plus customized weekly reports to participants). The main question is to learn whether participants' use of positive airway pressure therapy will differ between the participants who receive the new program immediately versus delayed. Participants assigned to the delayed program will receive usual care while waiting for the program to begin.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized to immediate versus waitlist control in a 1:1 ratio.
Our project is at the forefront of consumer wearable research, leveraging the recent capabilities of consumer wearables to provide pulse oximetry data during sleep, to uncover new ways to promote PAP usage among patients with obstructive sleep apnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Behavioral: Immediate InterventionParticipants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks. |
| Waitlist control | Other | Behavioral: Waitlist controlParticipants will receive usual care from the sleep center for 6 weeks and then be provided with a consumer wearable to wear for 4 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Prescribed PAP therapy from the sleep center for > 1 week
- Have an active profile in our Center's ResMed AirView or Respironics Care Orchestrator accounts for > 1 week
- Non-adherent with PAP therapy
- Willing to continue using current PAP device for 28 days continuously
- Have an electronic device compatible with the wearable app
Key exclusion criteria (7 listed)
- Diagnosis of heart failure, chronic lung disease, dementia, active substance use disorder
- Use home oxygen
- Unstable medical or psychiatric illness
- Planned non-use of PAP therapy (e.g., waiting for replacement of recalled PAP device)
- Planned surgery or hospitalization during study period
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 |
|---|---|---|
| Immediate InterventionParticipants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable. | Behavioural | Immediate Intervention |
| Waitlist controlParticipants only receive usual care from the sleep center. | Behavioural | Waitlist control |
Primary outcome
Change in PAP Adherence (Minutes) From Baseline to Post-treatment (T3)
Time frame: 5 weeks
Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3), which was 35 days after randomization.
1 secondary outcome
Change in PAP Adherence (Days Used >= 4 Hours) From Baseline to Post-treatment (T3)
Time frame: 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39207912Mak S, Ash G, Liang LJ, Der-McLeod E, Ghadimi S, Kewalramani A, Naeem S, Zeidler M, Fung C. Testing a Consumer Wearables Program to Promote the Use of Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 19;13:e60769. doi: 10.2196/60769.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
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Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Constance H. Fung, MD, MSHS principal investigator
VA Greater Los Angeles Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Intervention in people with Obstructive Sleep Apnea, run by VA Greater Los Angeles Healthcare System 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 5 inclusion and 7 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 3 Aug 2026. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in PAP Adherence (Minutes) From Baseline to Post-treatment (T3) (time frame: 5 weeks). 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 NCT06039865, which also lists 1 linked publication.
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 3 Aug 2026.