Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570629
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-01-25
Brief Title:
Addressing Unintentional Leakage When Using Nasal CPAP - Study B
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mechanisms of Weight Gain During CPAP Treatment in Patients With Obstructive Sleep Apnea
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 B will consist of a controlled crossover trial to compare unintentional leak during the use of an oronasal mask versus a nasal mask with a chinstrap among subjects who remain with excessive leak at the end of study A The order of interventions will be randomized One of the groups will initially use an oronasal mask for 10 days A washout period of 7 days under nasal CPAP will follow After washout subjects will continue using a nasal mask and will be asked to use a chinstrap for another 10 days In the other group the order of interventions will be the opposite
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