Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-05 @ 5:49 PM
Study NCT ID:
NCT03200769
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2017-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D004828', 'term': 'Epilepsies, Partial'}], 'ancestors': [{'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'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2021-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-29', 'studyFirstSubmitDate': '2017-06-12', 'studyFirstSubmitQcDate': '2017-06-26', 'lastUpdatePostDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients from group IIa and IIb with decreased seizure frequency', 'timeFrame': 'At 3 months', 'description': 'Decreased \\> 50% after CPAP treatment'}], 'secondaryOutcomes': [{'measure': 'Number of patients from group IIa and IIb with decreased seizure frequency', 'timeFrame': 'At 6 months ; At 12 months', 'description': 'Decreased \\> 50% after CPAP treatment'}, {'measure': 'Number of patients from group III with decreased seizure frequency', 'timeFrame': 'At 3 months ; At 6 months ; At 12 months', 'description': 'Decreased \\> 50% after CPAP treatment'}, {'measure': 'Impact of AHI on the number of night seizures', 'timeFrame': 'At 12 months', 'description': 'Does the AHI has an impact on the number of night seizure?'}, {'measure': 'Impact of the localisation and the type of epilepsy based on patient medical history exam (video-electroencephalogram) on the SAS risk', 'timeFrame': 'At 12 months', 'description': 'Does the AHI is impacted by the localisation and the type of epilepsy?'}, {'measure': 'Number of seizures based on the seizures diary', 'timeFrame': 'At 12 months', 'description': 'Impact of SAS treatment on the pharmacoresistance'}, {'measure': 'Number of patients who became drug-susceptible based on the seizures diary', 'timeFrame': 'At 3 months ; At 6 months ; At 12 months', 'description': 'Impact of SAS treatment on the pharmacoresistance'}, {'measure': 'Quality of life questionnaire (QOLIE 31)', 'timeFrame': 'At 3 months ; At 6 months ; At 12 months', 'description': 'Impact of SAS treatment on the quality of life'}, {'measure': 'Anxiety and depression questionnaire (BECK)', 'timeFrame': 'At 3 months ; At 6 months ; At 12 months', 'description': 'Impact of SAS treatment on anxiety and depression'}, {'measure': 'Somnolence questionnaire (Epworth)', 'timeFrame': 'At 3 months ; At 6 months ; At 12 months', 'description': 'Impact of SAS treatment on somnolence'}, {'measure': 'Cognitive capacity questionnaire (MOCA)', 'timeFrame': 'At 3 months ; At 6 months ; At 12 months', 'description': 'Impact of SAS treatment on cognitive capacity questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CPAP', 'Sleep Apnea Syndrome', 'Pharmacoresistant Epilepsy', 'Apnea Hypopnea-Index'], 'conditions': ['Sleep Apnea Syndromes', 'Epilepsies, Partial']}, 'descriptionModule': {'briefSummary': 'Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy. The primary goal is to evaluate the efficacity after 3 months of obstructive sleep apnea syndrome treatment by CPAP on the epilepsy seizures frequency.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female age ≥ 18.\n* Patient suffering of pharmacoresistant epilepsy.\n* Frequency of epilepsy crisis : minimum 4 per month.\n* Antiepileptic drug on a stable dose for at least 2 months.\n* SA-SDQ score ≥ 25.\n* Written informed consent obtained.\n* Patient affiliated with a social security regimen.\n\nExclusion Criteria:\n\n* Pregnant females (female subjects who are lactating are not excluded).\n* Anterior CPAP treatment.\n* Central apnea \\>20% during the initial polysomnography.\n* Mental retardation or severe cognitive impairment.\n* Presence of pseudo-crisis.'}, 'identificationModule': {'nctId': 'NCT03200769', 'acronym': 'SASER', 'briefTitle': 'Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Study of the Efficacy of the Treatment of Sleep Apnea Syndrome by CPAP in Pharmacoresistant Epilepsy', 'orgStudyIdInfo': {'id': '2012_66'}, 'secondaryIdInfos': [{'id': '2013-A01156-39', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group I', 'description': 'AHI/h \\< 15'}, {'type': 'EXPERIMENTAL', 'label': 'Group IIa', 'description': '15 \\< AHI/h \\< 30. Randomization group. Intervention : CPAP active', 'interventionNames': ['Device: CPAP active']}, {'type': 'EXPERIMENTAL', 'label': 'Group IIb', 'description': '15 \\< AHI/h \\< 30. Randomization group. Intervention : CPAP placebo during the first 3 months. After this period, the patient will have the possibility to continue with an active CPAP.', 'interventionNames': ['Device: CPAP placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group III', 'description': 'AHI/h \\> 30. Intervention : CPAP active', 'interventionNames': ['Device: CPAP active']}], 'interventions': [{'name': 'CPAP active', 'type': 'DEVICE', 'description': 'CPAP PR1 Philips Respironics with a pression between 4 and 14 mm Hg', 'armGroupLabels': ['Group III', 'Group IIa']}, {'name': 'CPAP placebo', 'type': 'DEVICE', 'description': 'CPAP PR1 Philips Respironics with a constant pression of 4 mm Hg.', 'armGroupLabels': ['Group IIb']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille - Rue Emile LAINE - Hopitâl Roger Salengro Rez de Chaussée - Neurophysiologie Clinique', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Philippe DERAMBURE, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}