Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP) Trial

Sponsor

VA Greater Los Angeles Healthcare System (U.S. Fed)

Overall Status

Not yet recruiting

CT.gov ID

NCT06039865

Collaborator

University of California, Los Angeles (Other)

Enrollment

Location

Arms

12.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Behavioral: Immediate Intervention Behavioral: Waitlist control	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Augmenting Obstructive Sleep Apnea Chronic Care Management With Consumer Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy

Anticipated Study Start Date :

Sep 12, 2023

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate Intervention Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.	Behavioral: Immediate Intervention Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.
Other: Waitlist control 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.	Behavioral: Waitlist control Participants only receive usual care from the sleep center.

Arm

Intervention/Treatment

Experimental: Immediate Intervention

Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.

Behavioral: Immediate Intervention

Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.

Other: Waitlist control

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.

Behavioral: Waitlist control

Participants only receive usual care from the sleep center.

Outcome Measures

Primary Outcome Measures

PAP adherence (minutes) [5 weeks]
Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3).

Secondary Outcome Measures

PAP adherence (percent of days used >= 4 hours) [5 weeks]
Change in the percent of days PAP was used >= 4 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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