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NCT Number: NCT04675268

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oximetry

Diagnostic Test

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

Primary outcomes

  1. Variability in oxygen desaturation index 3 percent

    Time frame: 7 nights

    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).

  2. Variability in oxygen desaturation index 4 percent

    Time frame: 7 nights

    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).

  3. Variability in mean oxygen saturation

    Time frame: 7 nights

    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).

  4. Variability in minimal oxygen saturation

    Time frame: 7 nights

    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).

  5. Variability in percentage of time oxygen saturation < 90 percent

    Time frame: 7 nights

    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).

  6. Variability in percentage of time oxygen saturation < 88 percent

    Time frame: 7 nights

    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. Variability in percentage of time oxygen saturation < 80 percent

    Time frame: 7 nights

    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).

Secondary outcomes

  1. Evaluation of clinical predictors (alcohol intake, sleep duration) of this variability.

    Time frame: 7 nights

    Based on sleep diaries, the correlation between alcohol intake and/or sleep duration and the variability of nocturnal oxygen parameters is evaluated.

  2. Evaluation of clinical predictors (body position) of this variability.

    Time frame: 7 nights

    Based on data of the McRoberts Move monitor, the correlation between body position and the variability of nocturnal oxygen parameters is evaluated.

  3. To compare nocturnal oxygen (and PPG) parameters measured at home and during a diagnostic polysomnography in hospital.

    Time frame: 8 nights (7 nights at home and 1 night in the hospital)

    Comparison of the different oxygen parameters evaluated during 7 nights at home and during 1 night in the hospital

  4. Variability in surrogate AHI

    Time frame: 7 nights

    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.

  5. Variability in cardiovascular comorbidity

    Time frame: 7 nights

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bertien Buyse, MD, PhD

CONTACT

[email protected]

+32 16 342522

Dries Testelmans, MD, PhD

CONTACT

[email protected]

+32 16 342522

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea

Acronym: VARIOUS

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2020
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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