An interventional study of oximetry in Obstructive Sleep Apnea, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Diagnostic
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.
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.
1,422 studies on the registry are indexed under Apnea; 158 are open to participants now.
This study's planned enrollment of 130 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will undergo 7 nights home monitoring with oximetry.
Diagnostic Test: oximetry
A CE medical approved polygraphy device (Dreamscan 2 - Medatec) will be used to obtain oximetry (and PPG) data
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).
Time frame: 7 nights
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).
Time frame: 7 nights
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).
Time frame: 7 nights
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).
Time frame: 7 nights
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).
Time frame: 7 nights
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).
Time frame: 7 nights
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).
Time frame: 7 nights
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.
Time frame: 7 nights
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.
Time frame: 7 nights
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
Time frame: 8 nights (7 nights at home and 1 night in the hospital)
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.
Time frame: 7 nights
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.
Time frame: 7 nights
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Universitaire Ziekenhuizen KU Leuven