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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2022
  • participants needed
    130
  • sponsor
    Universitaire Ziekenhuizen Leuven
Updated on 22 February 2021

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.

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.

Details
Condition Obstructive sleep apnea, obstructive sleep apnoea, obstructive sleep apnea syndrome
Treatment Oximetry
Clinical Study IdentifierNCT04675268
SponsorUniversitaire Ziekenhuizen Leuven
Last Modified on22 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: obstructive sleep apnoea or Obstructive sleep apnea or obstructive sleep apnea syndrome?
Do you have any of these conditions: Obstructive sleep apnea or obstructive sleep apnea syndrome or obstructive sleep apnoea?
Patients with suspected OSA with a clinical indication to perform a polysomnography

Exclusion Criteria

Patients younger than 18 yrs
Patients not able to read or understand the informed consent content on the purpose of the study, due to visual, intellectual or language issues
Patients with neuromuscular disease or chest wall disease with suspected hypoventilation
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