Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-10 @ 9:42 AM
Study NCT ID:
NCT02913651
Status:
COMPLETED
Last Update Posted:
2017-01-25
First Post:
2016-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009290', 'term': 'Narcolepsy'}, {'id': 'D002385', 'term': 'Cataplexy'}, {'id': 'D020177', 'term': 'Idiopathic Hypersomnia'}], 'ancestors': [{'id': 'D006970', 'term': 'Disorders of Excessive Somnolence'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017286', 'term': 'Polysomnography'}], 'ancestors': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-24', 'studyFirstSubmitDate': '2016-09-22', 'studyFirstSubmitQcDate': '2016-09-23', 'lastUpdatePostDateStruct': {'date': '2017-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High Frequencies (HF)', 'timeFrame': 'During the polysomnography (one night)', 'description': 'Nocturnal parasympathetic activity (HF parameter of heart rate variability analysis)'}], 'secondaryOutcomes': [{'measure': 'Heart rate variability (HRV)', 'timeFrame': 'During the polysomnography (one night)', 'description': 'HRV is measured by the polysomnography. It is a composite outcome : Standard Deviation of NN intervals (SDNN), the proportion of NN30 (and 50) divided by total number of NNs (pNN30, pNN50), Root Mean Square of Successive Differences (RMSSD), Standard Deviation type 1 and 2 (SD1, SD2), Low Frequencies (LF), Very Low Frequencies (VLF), LF/HF ratio and Ptot indexes'}, {'measure': 'Apnea-Hypopnea Index (AIH)', 'timeFrame': 'During the polysomnography (one night)'}, {'measure': 'Epworth Sleepiness Scale (ESS)', 'timeFrame': 'Before the polysomnography (one night)', 'description': 'It examines eight different situations using a 4-grade scale ranging from 0 (no chances of napping) to 3 (high chances of napping). Subjects were defined as sleepy if they had an ESS\\>10'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Idiopathic hypersomnia', 'heart rate variability', 'parasympathetic activity', 'autonomic arousal response'], 'conditions': ['Narcolepsy', 'Cataplexy']}, 'descriptionModule': {'briefSummary': 'Autonomic nervous system dysfunction has been described in narcolepsy with cataplexy affecting the sympathetic function. In this study the investigators analyzed whether altered diurnal and nocturnal cardiovascular control is present in idiopathic hypersomnia. Drug-free patients diagnosed with idiopathic hypersomnia and age-matched controls were included. Clinical data, 24-h polysomnography, heart rate variability and the heart rate response to spontaneous arousal are analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Idiopathic hypersomnia patients and no idiopathic hypersomnia patient', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIdiopathic hypersomnia patients\n\n* idiopathic hypersomnia diagnosis\n* complaints of excessive daytime sleepiness for \\>1 year\n* a night-time length \\>10 h for 3 weeks before polysomnography as assessed by a sleep diary\n\nInclusion Criteria:\n\nno idiopathic hypersomnia patients\n\n* no sleep complaints and excessive daytime sleepiness (Epworth sleep questionnaire score \\<10\n\nExclusion Criteria (both):\n\n* Narcolepsy-cataplexy\n* sleep irregularities and sleep deprivation symptoms\n* lack of neurological or psychiatric diseases\n* upper airway resistance syndrome\n* periodic limbs movements\n* cerebral lesion\n* medication or drinks affecting sleep and wake state'}, 'identificationModule': {'nctId': 'NCT02913651', 'briefTitle': 'Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Cardiovascular Variability and Heart Rate Arousal Response in Idiopathic Hypersomnia', 'orgStudyIdInfo': {'id': '1600111'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Idiopathic hypersomnia', 'description': 'Drug-free patients diagnosed with idiopathic hypersomnia from 01/01/11 to 15/09/15', 'interventionNames': ['Device: Polysomnography']}, {'label': 'Controls', 'description': 'Patients with no sleep complaints, having a 24-h ambulatory ad libitum polysomnography', 'interventionNames': ['Device: Polysomnography']}], 'interventions': [{'name': 'Polysomnography', 'type': 'DEVICE', 'description': 'The polysomnography, for both groups, was performed accordance with standard practice', 'armGroupLabels': ['Controls', 'Idiopathic hypersomnia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de SAINT-ETIENNE', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Emilia SFORZA, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU de SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}