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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention | Experimental | Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Intervention | Behavioral | Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PAP adherence (minutes) | Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3). | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PAP adherence (percent of days used >= 4 hours) | Change in the percent of days PAP was used >= 4 hours | 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Constance H. Fung, MD, MSHS | VA Greater Los Angeles Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System | North Hills | California | 91343 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39207912 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 7, 2026 |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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| Waitlist control | Behavioral | Participants only receive usual care from the sleep center. |
|
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |