Ignite Creation Date:
2024-05-06 @ 1:48 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04128930
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2019-10-14
Brief Title:
Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
Recruiting
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:
ATMOS
Brief Summary:
The aim of this trial is to compare two different ways of CPAP titration
CAP titration with fixed pressure vs auto-titrating CPAP
CAP titration with fixed pressure vs auto-titrating CPAP
Detailed Description:
Continuous positive airway pressure CPAP for the treatment of moderate obstructive sleep apnea OSA is only reimbursed in Belgium after in-laboratory overnight titration Nevertheless in a recent clinical practice guideline of the AASM it is recommended that PAP therapy can be initiated using either in-laboratory titration or auto-titrating CPAP APAP at home in OSA patients without significant comorbidities Indeed several studies evaluated the impact of titration with APAP at home in these patients and showed that the outcome is comparable with in-hospital titration Up to now evidence for home titration with fixed CPAP and follow-up via telemonitoring is very limited The use of sleep laboratory space is costly and limits access for diagnostic studies This study aims to evaluate whether CPAP titration at home with fixed CPAP produces outcomes equal to those following APAP titration
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?:
False
Is an FDA AA801 Violation?:
None