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

Obstructive Sleep Apnea Clinical Trial

— VARIOUS  

Official title:

Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04675268
• Other study ID #: s64296
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: October 2021
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Bertien Buyse, MD, PhD
• Phone: +32 16 342522
• Email: Bertien.Buyse[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• oximetry
A CE medical approved polygraphy device (Dreamscan 2 - Medatec) will be used to obtain oximetry (and PPG) data

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variability in oxygen desaturation index 3 percent	Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in number of oxygen desaturation events with desaturation higher or equal to 3% is evaluated.; Mean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).	7 nights
Primary	Variability in oxygen desaturation index 4 percent	Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in number of oxygen desaturation events with desaturation higher or equal to 4% is evaluated.; Mean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).	7 nights
Primary	Variability in mean oxygen saturation	Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in mean nocturnal oxygen saturation during 7 consecutive nights at home is evaluated.; Mean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).	7 nights
Primary	Variability in minimal oxygen saturation	Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in mean nocturnal oxygen saturation during 7 consecutive nights at home is evaluated.; Mean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).	7 nights
Primary	Variability in percentage of time oxygen saturation < 90 percent	Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in mean nocturnal oxygen saturation during 7 consecutive nights at home is evaluated.; Mean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).	7 nights
Primary	Variability in percentage of time oxygen saturation < 88 percent	Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in mean nocturnal oxygen saturation during 7 consecutive nights at home is evaluated.; Mean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).	7 nights
Primary	Variability in percentage of time oxygen saturation < 80 percent	Using a CE medical approved polygraphy device (Dreamscan 2 - Medatec) the variability in mean nocturnal oxygen saturation during 7 consecutive nights at home is evaluated.; Mean +/- SD or median (interquartile range) depending whether or not the 7 night data present a Gaussian distribution, and the coefficient of variation (CV).	7 nights
Secondary	Evaluation of clinical predictors (alcohol intake, sleep duration) of this variability.	Based on sleep diaries, the correlation between alcohol intake and/or sleep duration and the variability of nocturnal oxygen parameters is evaluated.	7 nights
Secondary	Evaluation of clinical predictors (body position) of this variability.	Based on data of the McRoberts Move monitor, the correlation between body position and the variability of nocturnal oxygen parameters is evaluated.	7 nights
Secondary	To compare nocturnal oxygen (and PPG) parameters measured at home and during a diagnostic polysomnography in hospital.	Comparison of the different oxygen parameters evaluated during 7 nights at home and during 1 night in the hospital	8 nights (7 nights at home and 1 night in the hospital)
Secondary	Variability in surrogate AHI	Based on a previously developed algorithm, based on oximetry (including PPG), a surrogate AHI can be calculated. The variability in the surrogate AHI during 7 nights is evaluated.	7 nights
Secondary	Variability in cardiovascular comorbidity	Based on a previously developed algorithm, based on oximetry (including PPG), the cardiovascular comorbidity can be estimated. The variability in this algorithm during 7 nights is evaluated.	7 nights