Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-31 @ 2:14 PM
Study NCT ID:
NCT05822128
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2023-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alternative Epworth Sleepiness Scale ESS-ALT in French
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-23', 'studyFirstSubmitDate': '2023-03-27', 'studyFirstSubmitQcDate': '2023-04-07', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validation of the alternative Epworth Daytime Sleepiness Scale -ALT adapted to the elderly and geriatric population in French', 'timeFrame': '24 hours', 'description': 'forward and backward translation" between English and French, and correlation with the ESS sleepiness scale.'}], 'secondaryOutcomes': [{'measure': 'Study of the correlation between the results of the French ESS-ALT and polysomnography data', 'timeFrame': '24 hours', 'description': 'Statistical comparison to identify the intrinsic validity of the ESS-ALT'}, {'measure': 'Study of the correlation between the results of the French ESS-ALT and MSLT (Multiple Sleep Latency Test) data', 'timeFrame': '24 hours', 'description': 'Statistical comparison to identify the intrinsic validity of the ESS-ALT'}, {'measure': 'intrinsic validity of the ESS-ALT in French', 'timeFrame': '24 months', 'description': 'Statistical comparison to identify the intrinsic validity of the ESS-ALT'}, {'measure': 'Study of the correlation between the ESS-ALT cohort in French and the ESS-ALT cohort in Germany', 'timeFrame': '24 months', 'description': 'Statistical comparison to identify the intrinsic validity of the French version of ESS-ALT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Excessive daytime sleepiness', 'Elderly', 'Epworth Sleepiness Scale'], 'conditions': ['Excessive Daytime Sleepiness']}, 'descriptionModule': {'briefSummary': "The Epworth Sleepiness Scale (ESS) is undoubtedly the most commonly used tool in daily clinical practice to assess daytime sleepiness in patients of all ages by means of a self-administered questionnaire.\n\nIn elderly subjects, the clinician is often confronted with difficulties in accurately estimating the ESS score and measuring subjective daytime sleepiness. Indeed, according to Onen et al, the ESS tends to underestimate the prevalence of sleep disorders in the geriatric population, mainly due to non-response to problematic items, namely:\n\n* Item 3: Sitting, inactive in a public place (cinema, theater, meeting)\n* Item 8: In a car that has been stopped for a few minutes.\n\nIn order to overcome this problem, Janine Gronewold's German team has developed and begun work on the validation of an alternative version of the ESS, the ESS-ALT, adapted to the population of interest, in German.\n\nThe aim of the present work is to adapt the ESS-ALT in French, then to study its correlation with sleep data recorded by nocturnal polysomnography, and among the secondary objectives, to correlate it with sleep latency during iterative sleep latency tests, in order to propose to the clinician a simple, reproducible tool, allowing to measure daytime sleepiness in elderly subjects.", 'detailedDescription': "Developed in 1991 by Dr. Johns at the University of Melbourne and modified by him in 1997, the Epworth Sleepiness Scale (ESS) is undoubtedly the most commonly used tool in daily clinical practice to assess daytime sleepiness in patients of all ages by means of a self-administered questionnaire.\n\nIn elderly subjects, the clinician is often confronted with difficulties in accurately estimating the ESS score and measuring subjective daytime sleepiness. Indeed, according to Onen et al, the ESS tends to underestimate the prevalence of sleep disorders in the geriatric population, mainly due to non-response to problematic items, namely:\n\n* Item 3: Sitting, inactive in a public place (cinema, theater, meeting)\n* Item 8: In a car that has been stopped for a few minutes.\n\nIn order to overcome this problem, Janine Gronewold's German team has developed and begun work on the validation of an alternative version of the ESS, the ESS-ALT, adapted to the population of interest, in German.\n\nThe aim of the present work is to adapt the ESS-ALT in French, then to study its correlation with sleep data recorded by nocturnal polysomnography, and among the secondary objectives, to correlate it with sleep latency during iterative sleep latency tests, in order to propose to the clinician a simple, reproducible tool, allowing to measure daytime sleepiness in elderly subjects"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Seniors with suspected sleep disorders referred for assessment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient 65 years of age and older\n* Consulting for sleep disorders\n* Enrolled in a social security system or entitled to it\n* Patient informed and having expressed his non-opposition to participate in the research\n\nExclusion Criteria:\n\n* Severe psychiatric or cognitive disorders that do not allow the completion of examinations/questionnaires\n* Patients who are dependent for all acts of daily life\n* Patients with a very short life expectancy\n* Patients under guardianship or curatorship\n* Patients under AME\n* Patients whose first language is not French\n* Patients with visual or cognitive impairments that make reading impossible'}, 'identificationModule': {'nctId': 'NCT05822128', 'acronym': 'SOMNOLD', 'briefTitle': 'Alternative Epworth Sleepiness Scale ESS-ALT in French', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Sleepiness in the Elderly: Validation of the Alternative Epworth Sleepiness Scale ESS-ALT in French', 'orgStudyIdInfo': {'id': 'APHP230377'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Seniors with suspected sleep disorders referred for assessment', 'description': 'Seniors with suspected sleep disorders referred for assessment', 'interventionNames': ['Other: Test of an alternative Epworth Sleepiness Scale ESS-ALT in French']}], 'interventions': [{'name': 'Test of an alternative Epworth Sleepiness Scale ESS-ALT in French', 'type': 'OTHER', 'description': 'Seniors recruited into the study will test the Epworth Alternate Sleepiness Scale -ALT', 'armGroupLabels': ['Seniors with suspected sleep disorders referred for assessment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94205', 'city': 'Ivry-sur-Seine', 'country': 'France', 'facility': 'Hospital Charles Foix', 'geoPoint': {'lat': 48.81568, 'lon': 2.38487}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'service des pathologies du sommeil, hôpital Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}