Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome.

Presently, there isn't any international recommendation to evaluate vigilance in Obstructive Sleep Apnea Syndrome. The French Society of Sleep Research and Medicine (SFRMS) recommend evaluating professional driver with a MWT but no recommendation exists for other patients. After a minimal treatment of 4 weeks, the physician has to evaluate the drowsiness risk of these patients using either an objective test like the MWT or a subjective one. In the university hospital Amiens-Picardie, since the 01/01/2015, every patient with an Obstructive Sleep Apnea Syndrome diagnosed by a polysomnography or a ventilatory polygraphy had a MWT after 4 weeks of treatment. At each time of the evaluation, Epworth Sleepiness Scale, tiredness score of Pichot, and depressive score of Beck are performed.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Amiens

Amiens, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

patients treated by CPAP for Obstructive Sleep Apnea Syndrome

Exclusion criteria

Central Apnea Syndrome
Central Hypersomnia

Treatment and study plan

Epworth Sleepiness Scale

Diagnostic Test

Maintenance Wakefulness Test

Primary outcomes

Evaluation of the correlation between the MWT sleep latency scores and the results of the Epworth Sleepiness Scale after CPAP treatment

Time frame: one day

Three levels of vigilance are defined by the MWT : more than 34 min is rated as good vigilance; ≥ 20 et < 34 min as intermediate vigilance; under 20 min as bad vigilance.
Evaluation of the correlation between the MWT sleep latency scores and the results of the Epworth Sleepiness Scale after CPAP treatment

Time frame: one day

Two levels of vigilance are defined by the ESS score: score ≥11: bad vigilance, <11: good vigilance

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome

Acronym: SAHOS-TIME

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Aug 14, 2018
Registry last updated: Jul 16, 2020

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.

Published trials that share one or more normalized conditions with this study.

Completed