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Hypoxic Burden and Sleepiness in Treated OSA Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06700837
Acronym
MWTBH
Enrollment
141
Registered
2024-11-22
Start date
2024-01-01
Completion date
2024-09-01
Last updated
2024-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep, OSA

Keywords

Polysomnography, Polygraphy, Hypoxic burden

Brief summary

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.

Interventions

OTHERImpact 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
Objective residual sleepiness in a treated OSAHS population as measured by the Multiple Sleep Latency Test (MSLT) in relation to hypoxic load.6 months.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026