Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Obstructive Sleep Apnea
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 eva...

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.

Tracking Information

NCT #
NCT04675268
Collaborators
Not Provided
Investigators
Principal Investigator: Bertien Buyse, MD, PhD Universitaire Ziekenhuizen Leuven