Clinical trial NCT06039865: Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP) Trial
Official title: Augmenting Obstructive Sleep Apnea Chronic Care Management With Consumer Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Wearable
Pulse oximetry
Sleep apnea
Treatment adherence
Lead sponsor: VA Greater Los Angeles Healthcare System
Sponsor class: FED
Collaborators: name: University of California, Los Angeles
First posted: 2023-09-15
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: PAP adherence (minutes)
timeFrame: 5 weeks
Secondary outcomes:
measure: PAP adherence (percent of days used >= 4 hours)
timeFrame: 5 weeks
Other outcomes:
Locations:
city: North Hills
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System
name: Constance H. Fung, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References: