Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-08 @ 9:36 PM
Study NCT ID:
NCT03629834
Status:
COMPLETED
Last Update Posted:
2020-07-16
First Post:
2018-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-15', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the correlation between the MWT sleep latency scores and the results of the Epworth Sleepiness Scale after CPAP treatment', 'timeFrame': 'one day', 'description': '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.'}, {'measure': 'Evaluation of the correlation between the MWT sleep latency scores and the results of the Epworth Sleepiness Scale after CPAP treatment', 'timeFrame': 'one day', 'description': 'Two levels of vigilance are defined by the ESS score: score ≥11: bad vigilance, \\<11: good vigilance'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea Syndrome']}, 'referencesModule': {'references': [{'pmid': '32920453', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients treated by CPAP for Obstructive Sleep Apnea Syndrome\n\nExclusion Criteria:\n\n* Central Apnea Syndrome\n* Central Hypersomnia'}, 'identificationModule': {'nctId': 'NCT03629834', 'acronym': 'SAHOS-TIME', 'briefTitle': 'Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome', 'orgStudyIdInfo': {'id': 'PI2017_843_0034'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Epworth Sleepiness Scale', 'type': 'DIAGNOSTIC_TEST', 'description': 'Maintenance Wakefulness Test'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}