Hypoxic Burden and Sleepiness in Treated OSA Patients (MWTBH)

November 15, 2024 updated by: Hospices Civils de Lyon

Impact of Hypoxic Burden on Objective and Subjective Sleepiness in Patients Treated for Obstructive Sleep Apnea

The Maintenance of Wakefulness Test (MWT) is widely used to objectively assess sleepiness and make safety-related decisions and Epworth Sleepiness Scale (ESS) is the most used scale used to assess subjective sleepiness in sleep medicine.

Besides Obstructive Sleep Apnea measures are rapidly evolving and conventional measures such as apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) are increasingly being supplemented by measures of hypoxia such as hypoxic burden.

Residual AHI in treated OSA have limited predictive value for objective sleepiness. Therefore it seems particularly relevant to identify other predictors of both subjective and objective sleepiness.

This study aims at studying the influence of hypoxic burden as measure of both subjective or objective sleepiness.

We hypothesize that impaired nocturnal oxygenation might influence brain functioning during wakefulness and result in sleepiness as assessed by ESS and MWT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

141

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69317
        • Service de médecine du sommeil et des maladies respiratoires Hôpital de la Croix-Rousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study involves consecutive adult patients referred to the Center for Sleep and Respiratory Medicine for performance of MCT from September 2017 to January 2020.

Description

Inclusion Criteria:

  • OSA hospitalised to undergo both polysomnography (PSG) and the 40-min MWT in the Center for Sleep Medicine and Respiratory Disease, Lyon Academic Hospital from September 2017 to March 2020.

Exclusion Criteria:

  • - age <18 years
  • refusal to participate in the study
  • diagnosis of central disorder of hypersomnolence
  • missing data on the MWT
  • Epworth Sleepiness Scale (ESS)
  • apnea-hypopnea index (AHI).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hypoxic burden and Sleepiness in treated OSA patients

In this retrospective study, we reviewed the files of all patients with OSA hospitalised to undergo both polysomnography (PSG) and the 40-min MWT in the Center for Sleep Medicine and Respiratory Disease, Lyon Academic Hospital from September 2017 to January 2020.

All these patients underwent a full night polysomnography.
Other: Impact of hypoxic burden on objective and subjective sleepiness in patients treated for Obstructive Sleep apnea
To determine whether hypoxic load is a predictive marker of objective residual sleepiness measured by MCT in a treated OSAHS population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Objective residual sleepiness in a treated OSAHS population as measured by the Multiple Sleep Latency Test (MSLT) in relation to hypoxic load.
Time Frame: 6 months.
6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Dr Pierre TANKERE, MD, Msc, Service de médecine du sommeil et des maladies respiratoires Hôpital de la Croix-Rousse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Estimated)

November 22, 2024

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-5474

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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