Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570616
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-01-25
Brief Title:
Addressing Unintentional Leakage When Using Nasal CPAP - Study A
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Strategies for Controlling Unintentional Leakage in the Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Oral unintentional leak is a common side effect of continuous positive airway pressure CPAP for obstructive sleep apnea OSA treatment Management of oral unintentional leakage has not been standardized and the effectiveness of potential approaches have not been studied in controlled studies Higher levels of CPAP are associated with higher leak In the present study a sequential approach to control excessive unintentional leak will be tested In study A the reduction of therapeutic CPAP level will be tested In study B oronasal CPAP will be compared to nasal CPAP with a chinstrap
Detailed Description:
Study A will consist of a cross-over controlled randomized trial to compare unintentional leak during auto-CPAP and during fixed CPAP after the progressive reduction of fixed CPAP starting at the 90 th percentile obtained during a period of auto-CPAP The order of interventions will be randomized Auto-CPAP with a nasal mask will be used for 7 days In the fixed CPAP arm CPAP will be progressively reduced over a period of up to 21 days until leak is controlled or residual apnea-hypopnea index increases over 10 eventsh Subjects that persisted with excessive leak at the end of the Study A will be invited to Study B
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None