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

NCT04675268 | Recruiting

• 1 other identifier: s64296
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

oximetry

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

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

  7 nights

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

  7 nights

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

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

• Variability in surrogate AHI

  7 nights

• Variability in cardiovascular comorbidity

  7 nights

Study Arms (1)

7 night home oximetry

EXPERIMENTAL

Patients will undergo 7 nights home monitoring with oximetry.

Diagnostic Test: oximetry

Interventions

oximetry DIAGNOSTIC_TEST

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

7 night home oximetry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with suspected OSA with a clinical indication to perform a polysomnography

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Oximetry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Gas Analysis; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Bertien Buyse, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertien Buyse, MD, PhD

CONTACT

+32 16 342522; Bertien.Buyse@uzleuven.be

Dries Testelmans, MD, PhD

CONTACT

+32 16 342522; Dries.Testelmans@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: January 26, 2021
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Locations

BE (1)