Viewing Study NCT03067233


Ignite Creation Date: 2025-12-25 @ 2:54 AM
Ignite Modification Date: 2026-03-05 @ 4:55 PM
Study NCT ID: NCT03067233
Status: COMPLETED
Last Update Posted: 2024-04-08
First Post: 2017-02-24
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Automated Embedded Polysomnography (AEP)
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-04-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-05', 'studyFirstSubmitDate': '2017-02-24', 'studyFirstSubmitQcDate': '2017-02-28', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the automatic analysis', 'timeFrame': '72 hour', 'description': 'Comparison between polysomnographic analysis by two expert physicians and an automatic analysis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To develop and validate a reliable automatic analysis of the signals recorded during a polysomnography.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Insured by social security\n* Speak french\n\nExclusion Criteria:\n\n* Sleep disorder\n* Neurologic, respiratory or cardiac disease'}, 'identificationModule': {'nctId': 'NCT03067233', 'acronym': 'AEP', 'briefTitle': 'Automated Embedded Polysomnography (AEP)', 'organization': {'class': 'OTHER', 'fullName': "Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil"}, 'officialTitle': 'Automated Embedded Polysomnography', 'orgStudyIdInfo': {'id': 'ADOREPS_6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Polysomnography', 'description': 'Three polysomnographic recordings will be made on 3 consecutive nights with Electroencephalogry.', 'interventionNames': ['Other: Polysomnography']}], 'interventions': [{'name': 'Polysomnography', 'type': 'OTHER', 'description': 'Complete polysomnography with : Electroencephalogry, electro-oculography, surface electromyography (chin muscle, anterior tibial muscles), nasal pressure, respiratory movements (plethysmography of thoracic and abdominal inductance), pulse oximetry and electrocardiography.', 'armGroupLabels': ['Polysomnography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Service des pathologies du sommeil - GH Pitié-Slapêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}