Hypoxic Burden and Sleepiness in Treated OSA Patients

NCT ID: NCT06700837

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

141 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep OSA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Impact of hypoxic burden on objective and subjective sleepiness in patients treated for Obstructive Sleep apnea

Intervention Type OTHER

To determine whether hypoxic load is a predictive marker of objective residual sleepiness measured by MCT in a treated OSAHS population.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Pierre TANKERE, MD, Msc

Role: PRINCIPAL_INVESTIGATOR

Service de médecine du sommeil et des maladies respiratoires Hôpital de la Croix-Rousse

Locations

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Service de médecine du sommeil et des maladies respiratoires Hôpital de la Croix-Rousse

Lyon, , France

Site Status

Countries

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France

Other Identifiers

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23-5474

Identifier Type: -

Identifier Source: org_study_id

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