Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319482
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-03-06
Brief Title:
The Adherence of Proactive Sleep Apnea Therapy
Sponsor:
NovaResp Technologies Inc
Organization:
NovaResp Technologies Inc
Study Overview
Official Title:
Evaluating and Comparing the Adherence of Proactive Management Therapy for Sleep Apnea
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
The goal of this clinical trial is to compare the adherence to Positive Airway Pressure PAP therapy for newly diagnosed Obstructive Sleep Apnea OSA patients The main questions it aims to answer are
1 To compare the adherence of proactive therapy and conventional Automatic-PAP APAP therapy short-term 3 months and long-term 12 months for newly diagnosed OSA patients
2 To compare health outcomes AHI nightly usage leak and patient-reported outcomes between proactive therapy and conventional APAP therapy
1 To compare the adherence of proactive therapy and conventional Automatic-PAP APAP therapy short-term 3 months and long-term 12 months for newly diagnosed OSA patients
2 To compare health outcomes AHI nightly usage leak and patient-reported outcomes between proactive therapy and conventional APAP therapy
Detailed Description:
This is a double-blind randomized controlled superiority trial on newly diagnosed patients with obstructive sleep apnea Each participant will be provided with a APAP device The devices assigned to the test group will be modified to deliver the proactive therapy using Artificial Intelligence AI Devices assigned to the control group will deliver the conventional APAP therapy A sleep technician will be in regular contact with participants and track the time spent interacting with each participant At the conclusion of the first 3 months of the trial participants who are acceptant to therapy will be asked if they would like to continue participating for an additional 9 months Data will be collected by the PAP device and a series of self-reported questionnaires
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