Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2026-02-23 @ 1:53 PM
Study NCT ID:
NCT03376568
Status:
UNKNOWN
Last Update Posted:
2017-12-18
First Post:
2017-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Clinical Feature and Brain Function in Narcoleptic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009290', 'term': 'Narcolepsy'}, {'id': 'D020187', 'term': 'REM Sleep Behavior Disorder'}], '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'}, {'id': 'D020923', 'term': 'REM Sleep Parasomnias'}, {'id': 'D020447', 'term': 'Parasomnias'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-15', 'studyFirstSubmitDate': '2017-12-04', 'studyFirstSubmitQcDate': '2017-12-15', 'lastUpdatePostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'video-polysomnographic(PSG)', 'timeFrame': 'up to 100 weeks', 'description': 'video-PSG monitor sleep from 9:00pm to 6:00am'}], 'secondaryOutcomes': [{'measure': 'multiple sleep latency test (MSLT)', 'timeFrame': 'up to 100 weeks', 'description': 'MSLT in the next day of PSG record daytime sleepiness'}, {'measure': 'functional magnetic resonance imaging (fMRI)', 'timeFrame': 'up to 100 weeks', 'description': 'All narcolepsy with or withoutRBD accepts fMRI'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['polysomnographic', 'multiple sleep latency test', 'fMRI'], 'conditions': ['Narcolepsy', 'REM Sleep Behavior Disorder']}, 'descriptionModule': {'briefSummary': 'This study evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without RBD', 'detailedDescription': 'Polysomnographic (PSG) work-up one night to record nocturnal sleep condition in narcolepsy with /without RBD and control subjects including sleep macrostructure, occurrence of sleep onset rapid eye movement period(SOREMP), sleep stages distribution, and sleep arousle and leg movement and apnea hyponea index would be calculated.\n\nFunctional magnetic resonance imaging (fMRI) has been used in human to nonivasiverlyn investigate the neural mechanisms. This technique also apply to measures the variations in brain perfusion, structure and morphology in narcolepsy patients by assessing the blood oxygen level-dependent (BOLD) signal diffusion tensor imaging (DTI and voxel-based morphometry(VBM)\n\nThis study compare the feature of PSG and fMRI between narcolepsy with RBD, narcolepsy without RBD, control subject to evaluates the PSG and cerebral metabolism and functions in narcolepsy with/without RBD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will need about 40 narcoleptic patients with /without RBD between 10 and 65 years of age,and about 20 age- and gender-matched control subjects.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Narcolepsy meet to the international classification of sleep disorder,3rd edition (ICSD-3) , and RBD meet to the minimal diagnostic criteria according to the international Classification of Sleep, control subjects .\n\nExclusion Criteria:\n\nHistory of heart disease History of central nervous system organic psychosis AHI\\>15次/h History of alcohol dependence and drug abuse'}, 'identificationModule': {'nctId': 'NCT03376568', 'briefTitle': 'Investigation of Clinical Feature and Brain Function in Narcoleptic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tang-Du Hospital'}, 'officialTitle': 'Feature of Polysomnography and Cerebral Metabolism and Function in Narcolepsy With/Without RBD and Control Subject', 'orgStudyIdInfo': {'id': 'TDLL-201601-08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Narcolepsy with RBD & Control', 'description': 'Narcolepsy with REM sleep disorder lable(20) and Control subjects lable(20)'}, {'label': 'Narcolepsy with /without RBD', 'description': 'Narcolepsy with REM sleep disorder lable(20) and Narcolepsy without REM sleep disorderlable (20)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '710000', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guoyan Chen, MD', 'role': 'CONTACT', 'email': 'chenguoyan29@126.com', 'phone': '86-02984717792'}, {'name': 'Wen Wang, PhD', 'role': 'CONTACT', 'email': 'wangwen@fmmu.edu.cn', 'phone': '86-029778689'}], 'facility': 'Tangdu Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Guoyan Chen, MD', 'role': 'CONTACT', 'email': 'chenguoyan29@126.com', 'phone': '86-02984717792'}, {'name': 'Wen Wang, PhD', 'role': 'CONTACT', 'email': 'wangwen@fmmu.edu.cn', 'phone': '86-02984778689'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tang-Du Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}