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

NCT ID: NCT03629834

Last Updated: 2020-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-25

Study Completion Date

2018-10-08

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Epworth Sleepiness Scale

Maintenance Wakefulness Test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* patients treated by CPAP for Obstructive Sleep Apnea Syndrome

Exclusion Criteria

* Central Apnea Syndrome
* Central Hypersomnia
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 32920453 (View on PubMed)

Other Identifiers

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PI2017_843_0034

Identifier Type: -

Identifier Source: org_study_id

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