Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-28 @ 9:38 AM
Study NCT ID:
NCT06144892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2023-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comfort of Proactive Sleep Apnea Therapy
Sponsor:
NovaResp Technologies Inc
Organization:
Study Overview
Official Title:
Comparing the Comfort and Effectiveness of Proactive Airway Management Therapy for Sleep Apnea
Status:
NOT_YET_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:
None
Brief Summary:
The goal of this clinical trial is to compare in OSA patients who regularly adhere to CPAP therapy. The main question\[s\] it aims to answer are:
* To assess if proactive therapy can effectively treat OSA with lower mean therapy pressure compared to conventional APAP therapy
* To compare user comfort between proactive therapy and conventional APAP therapy
Participants will undergo the conventional APAP therapy and the new proactive therapy.
Researchers will compare nights in which conventional APAP was used and nights in which proactive therapy was used to see if patients were treated with lower pressures and effectively.
* To assess if proactive therapy can effectively treat OSA with lower mean therapy pressure compared to conventional APAP therapy
* To compare user comfort between proactive therapy and conventional APAP therapy
Participants will undergo the conventional APAP therapy and the new proactive therapy.
Researchers will compare nights in which conventional APAP was used and nights in which proactive therapy was used to see if patients were treated with lower pressures and effectively.
Detailed Description:
This is a blinded, randomised, crossover, study on patients diagnosed with obstructive sleep apnea who regularly adhere to APAP therapy. Data collection will span 23 consecutive nights for each participant. Participants will use a modified APAP device for 2 periods of 9 nights each, separated by 5 nights in which participants will use their personal APAP device. The modified APAP device is switchable between two therapy modes: a) proactive therapy, and b) conventional APAP therapy. Treatment for the 2 periods will be randomly assigned, with one period as the test period where the proactive therapy is used every night for 9 consecutive nights, and the other as the control period where their conventional APAP therapy (i.e., the participant's regular therapy but on the modified device) is used every night for 9 consecutive nights. Participants will be blinded to the therapy they are receiving during the test and control period. Data will be collected by the modified PAP device and at-home sleep apnea test ring.
Study Oversight
Has Oversight DMC:
False
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?: