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

Obstructive Sleep Apnea Clinical Trial

— mPAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06039865
• Other study ID #: 20233750
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: VA Greater Los Angeles Healthcare System
• Contact: Constance H. Fung, MD, MSHS
• Phone: 818 891-7711
• Email: Constance.Fung[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Immediate Intervention
Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.
• Waitlist control
Participants only receive usual care from the sleep center.

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System	North Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Greater Los Angeles Healthcare System	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PAP adherence (minutes)	Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3).	5 weeks
Secondary	PAP adherence (percent of days used >= 4 hours)	Change in the percent of days PAP was used >= 4 hours	5 weeks