Back to resultsChronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP) Trial (mPAP)
Primary Purpose
Obstructive Sleep Apnea
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediate Intervention
Waitlist control
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Wearable, Pulse oximetry, Sleep apnea, Treatment adherence
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
Sites / Locations
- VA Greater Los Angeles Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Immediate Intervention
Waitlist control
Arm Description
Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.
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.
Outcomes
Primary Outcome Measures
PAP adherence (minutes)
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)
Change in the percent of days PAP was used >= 4 hours
Full Information
NCT ID
NCT06039865
First Posted
September 8, 2023
Last Updated
September 8, 2023
Sponsor
VA Greater Los Angeles Healthcare System
Collaborators
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT06039865
Brief Title
Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP) Trial
Acronym
mPAP
Official Title
Augmenting Obstructive Sleep Apnea Chronic Care Management With Consumer Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 12, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Greater Los Angeles Healthcare System
Collaborators
University of California, Los Angeles
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Wearable, Pulse oximetry, Sleep apnea, Treatment adherence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate Intervention
Arm Type
Experimental
Arm Description
Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.
Arm Title
Waitlist control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Immediate Intervention
Intervention Description
Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist control
Intervention Description
Participants only receive usual care from the sleep center.
Primary Outcome Measure Information:
Title
PAP adherence (minutes)
Description
Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3).
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
PAP adherence (percent of days used >= 4 hours)
Description
Change in the percent of days PAP was used >= 4 hours
Time Frame
5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Constance H. Fung, MD, MSHS
Phone
818 891-7711
Ext
39311
Email
Constance.Fung@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Erin Der-Mcleod, MSW
Phone
818 891-7711
Ext
36067
Email
Erin.Der-Mcleod@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constance H. Fung, MD, MSHS
Organizational Affiliation
VA Greater Los Angeles Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System
City
North Hills
State/Province
California
ZIP/Postal Code
91343
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael K. Ong, MD
Phone
310-478-3711
Ext
42345
Email
Michael.Ong2@va.gov
First Name & Middle Initial & Last Name & Degree
Scott E. Krahl, PhD
Phone
(818) 895-5861
Email
Scott.Krahl@va.gov
12. IPD Sharing Statement
Learn more about this trial
Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP) Trial
We'll reach out to this number within 24 hrs