Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2026-01-01 @ 1:12 AM
Study NCT ID:
NCT04675268
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2020-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea (OSA)
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Study Overview
Official Title:
Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea
Status:
RECRUITING
Status Verified Date:
2024-07
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:
VARIOUS
Brief Summary:
The investigators would like to evaluate the variability of oxygen (and PPG) parameters during 7 nights at home. Oxygen (and PPG) parameters will also be evaluated during 1 night at the hospital (diagnostic polysomnography).
Based on currently developed algorithms, surrogate apnea-hypopnea index (AHI), cardiovascular status and the variability of these parameters will be evaluated.
Based on currently developed algorithms, surrogate apnea-hypopnea index (AHI), cardiovascular status and the variability of these parameters will be evaluated.
Detailed Description:
The main objective of this trial is to evaluate the variability in nocturnal oxygen (and PPG) parameters during 7 consecutive nights at home and to identify clinical predictors of variability in patients with suspected OSA.
Data regarding sleep position, alcohol intake and sleep duration will be evaluated (these parameters could be important to explain variability).
Additional objectives are to compare the parameters measured at home with the parameters measured during an in-hospital polysomnography.
The investigators will also evaluate variability in the surrogate AHI described by the group based on the measurements at home and the impact of multi-night evaluation of oxygen (and PPG) parameters on the recently developed mICS algorithm will be explored.
This study is a first explorative approach for further (multi-site) work to define the burden of OSA associated with cardiovascular or psychofunctional problems.
Data regarding sleep position, alcohol intake and sleep duration will be evaluated (these parameters could be important to explain variability).
Additional objectives are to compare the parameters measured at home with the parameters measured during an in-hospital polysomnography.
The investigators will also evaluate variability in the surrogate AHI described by the group based on the measurements at home and the impact of multi-night evaluation of oxygen (and PPG) parameters on the recently developed mICS algorithm will be explored.
This study is a first explorative approach for further (multi-site) work to define the burden of OSA associated with cardiovascular or psychofunctional problems.
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?: