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

NCT03629834 | Completed

• 1 other identifier: PI2017_843_0034
• Study Type: observational
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (2)

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

  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.

  one day

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

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

  one day

Interventions

Epworth Sleepiness Scale DIAGNOSTIC_TEST

Maintenance Wakefulness Test

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

all patients more than 18 years treated by CPAP for Obstructive Sleep Apnea Syndrome diagnosed at the Sleep Medicine Unity of the Amiens Hospital having a MWT between the 01/01/15 and 31/12/16 were included. Patients were excluded if they had an Central Apnea Syndrome, Central Hypersomnia, no driving license or if they refused.

You may qualify if:

• patients treated by CPAP for Obstructive Sleep Apnea Syndrome

You may not qualify if:

• Central Apnea Syndrome
• Central Hypersomnia

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, France

Location

Related Publications (1)

• Basille D, Baud ME, Andrejak C, Basille-Fantinato A, Jounieaux V. Correlation between the Epworth Sleepiness Scale and the Maintenance of Wakefulness Test in Obstructive Sleep Apnea Patients Treated with Positive Airway Pressure. Respir Med Res. 2020 Nov;78:100787. doi: 10.1016/j.resmer.2020.100787. Epub 2020 Aug 28.

  PMID: 32920453 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: August 14, 2018
• Study Start: January 25, 2018
• Primary Completion: October 8, 2018
• Study Completion: October 8, 2018
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)