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NCT Number: NCT06700837

Hypoxic Burden and Sleepiness in Treated OSA Patients

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.

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Key information

Conditions

Obstructive Sleep OSA

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Lyon, 69317, France

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

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

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: MWTBH

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 22, 2024
Registry last updated
Nov 22, 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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