Clinical trial NCT04675268: Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea (OSA)
Official title: Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: oximetry
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Variability in oxygen desaturation index 3 percent
timeFrame: 7 nights
measure: Variability in oxygen desaturation index 4 percent
timeFrame: 7 nights
measure: Variability in mean oxygen saturation
timeFrame: 7 nights
measure: Variability in minimal oxygen saturation
timeFrame: 7 nights
measure: Variability in percentage of time oxygen saturation < 90 percent
timeFrame: 7 nights
measure: Variability in percentage of time oxygen saturation < 88 percent
timeFrame: 7 nights
measure: Variability in percentage of time oxygen saturation < 80 percent
timeFrame: 7 nights
Secondary outcomes:
measure: Evaluation of clinical predictors (alcohol intake, sleep duration) of this variability.
timeFrame: 7 nights
measure: Evaluation of clinical predictors (body position) of this variability.
timeFrame: 7 nights
measure: To compare nocturnal oxygen (and PPG) parameters measured at home and during a diagnostic polysomnography in hospital.
timeFrame: 8 nights (7 nights at home and 1 night in the hospital)
measure: Variability in surrogate AHI
timeFrame: 7 nights
measure: Variability in cardiovascular comorbidity
timeFrame: 7 nights
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Bertien Buyse, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: