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

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ClinicalTrials.gov Identifier: NCT03629834
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

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
Obstructive Sleep Apnea Syndrome Diagnostic Test: Epworth Sleepiness Scale

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Study Type : Observational
Estimated Enrollment : 100 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 : January 25, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea


Intervention Details:
  • Diagnostic Test: Epworth Sleepiness Scale
    Maintenance Wakefulness Test


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 [ 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.

  2. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • patients treated by CPAP for Obstructive Sleep Apnea Syndrome

Exclusion Criteria:

  • Central Apnea Syndrome
  • Central Hypersomnia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629834


Locations
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France
CHU Amiens Recruiting
Amiens, France
Contact: Aurélie Basille-Fantinato, MD    +330322455961    basille.aurelie@chu-amiens.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT03629834     History of Changes
Other Study ID Numbers: PI2017_843_0034
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Sleep Apnea Syndromes
Apnea
Sleep Apnea, Obstructive
Sleepiness
Disease
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases