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

Primary Purpose

Obstructive Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
oximetry
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring oximetry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals LeuvenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

7 night home oximetry

Arm Description

Patients will undergo 7 nights home monitoring with oximetry.

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).
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).
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).

Secondary Outcome Measures

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.
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.
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
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.
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.

Full Information

First Posted
December 14, 2020
Last Updated
October 1, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04675268
Brief Title
Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea (OSA)
Acronym
VARIOUS
Official Title
Variability in Nocturnal Oxygen Parameters in Suspected Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 26, 2021 (Actual)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
oximetry

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
7 night home oximetry
Arm Type
Experimental
Arm Description
Patients will undergo 7 nights home monitoring with oximetry.
Intervention Type
Diagnostic Test
Intervention Name(s)
oximetry
Intervention Description
A CE medical approved polygraphy device (Dreamscan 2 - Medatec) will be used to obtain oximetry (and PPG) data
Primary Outcome Measure Information:
Title
Variability in oxygen desaturation index 3 percent
Description
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
Title
Variability in oxygen desaturation index 4 percent
Description
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
Title
Variability in mean oxygen saturation
Description
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
Title
Variability in minimal oxygen saturation
Description
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
Title
Variability in percentage of time oxygen saturation < 90 percent
Description
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
Title
Variability in percentage of time oxygen saturation < 88 percent
Description
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
Title
Variability in percentage of time oxygen saturation < 80 percent
Description
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
Secondary Outcome Measure Information:
Title
Evaluation of clinical predictors (alcohol intake, sleep duration) of this variability.
Description
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
Title
Evaluation of clinical predictors (body position) of this variability.
Description
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
Title
To compare nocturnal oxygen (and PPG) parameters measured at home and during a diagnostic polysomnography in hospital.
Description
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)
Title
Variability in surrogate AHI
Description
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
Title
Variability in cardiovascular comorbidity
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bertien Buyse, MD, PhD
Phone
+32 16 342522
Email
Bertien.Buyse@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Dries Testelmans, MD, PhD
Phone
+32 16 342522
Email
Dries.Testelmans@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertien Buyse, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dries Testelmans, MD, PhD
Phone
00 32 16 34 25 22
Email
dries.testelmans@uzleuven.be

12. IPD Sharing Statement

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

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