Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06039865
Status:
RECRUITING
Last Update Posted:
2024-03-26
First Post:
2023-09-08
Brief Title:
Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy mPAP Trial
Sponsor:
VA Greater Los Angeles Healthcare System
Organization:
VA Greater Los Angeles Healthcare System
Study Overview
Official Title:
Augmenting Obstructive Sleep Apnea Chronic Care Management With Consumer Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
mPAP
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 11 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None