NCT04675268

Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea (OSA)

Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	oximetry	A CE medical approved polygraphy device (Dreamscan 2 - Medatec) will be used to obtain oximetry (and PPG) data

Timeline

• Start date: 2021-01-26
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2020-12-19
• Last updated: 2024-07-03

Locations

1 site across 1 country: Belgium