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

• Sponsor: Centre Hospitalier Universitaire, Amiens (Other)
• Overall Status: Completed
• CT.gov ID: NCT03629834
• Collaborator: (none)
• Enrollment: 134
• Location: 1
• Actual Duration (Months): 8.4
• Patients Per Site Per Month: 15.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea Syndrome	Diagnostic Test: Epworth Sleepiness Scale

Study Design

• Study Type: Observational
• Actual Enrollment: 134 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome
• Actual Study Start Date: Jan 25, 2018
• Actual Primary Completion Date: Oct 8, 2018
• Actual Study Completion Date: Oct 8, 2018

Outcome Measures

Primary Outcome Measures

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

2. Evaluation of the correlation between the MWT sleep latency scores and the results of the Epworth Sleepiness Scale after CPAP treatment [one day]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients treated by CPAP for Obstructive Sleep Apnea Syndrome

Exclusion Criteria:

• Central Apnea Syndrome

• Central Hypersomnia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France

Sponsors and Collaborators

• Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire, Amiens
• ClinicalTrials.gov Identifier: NCT03629834
• Other Study ID Numbers: PI2017_843_0034
• First Posted: Aug 14, 2018
• Last Update Posted: Jul 16, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Sleepiness

Study Results

No Results Posted as of Jul 16, 2020