Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-26 @ 1:44 PM
Study NCT ID:
NCT04506892
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2020-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantitation of Glymphatic Functioning in Sleep and Meditative States
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'no masking is used in this protocol'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2020-07-17', 'studyFirstSubmitQcDate': '2020-08-06', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CSF flow change', 'timeFrame': 'baseline to 24 hours', 'description': 'Using MRI to assess the change in CSF flow in awake, sleep deprived, and meditative states'}], 'secondaryOutcomes': [{'measure': 'EEG changes', 'timeFrame': 'baseline to 24 hours', 'description': 'Looking at brain wave changes before and after intervention in Alpha, Beta, and Delta waves associated with light to deep sleep. The lowest bandwidth for alpha waves is 8 while the highest is 12. The lowest bandwidth for Beta waves is 13 Hz while the highest is 30 Hz. The lowest bandwidth for Delta waves is .4 Hz and the highest is 4 Hz.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glymphatic system', 'meditation'], 'conditions': ['Parkinson Disease', 'Sleep']}, 'descriptionModule': {'briefSummary': 'This involves development and application of magnetic resonance imaging (MRI) methods for visualizing hemodynamic and metabolic relationships in healthy volunteers with advanced meditation experience.', 'detailedDescription': 'This study is evaluating the glymphatic system during awake, sleep, and meditative states.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 14-45\n* "Adept meditator status"\n\nExclusion Criteria:\n\n* Any non-MR compatible material implant, or contraindication to MR scanning\n* Claustrophobia or inability to lie still for prolonged periods of time\n* Participants with a recent (less than 2 months) infection, tattoo, or wound\n* No consumption of stimulants or alcohol within 12 hours of the study visit\n* clinical diagnosis of any major neurological or psychological condition\n* Taking benzodiazepines, cholinestorase inhibitors, anti-psychotics, opioids, MAO inhibitors'}, 'identificationModule': {'nctId': 'NCT04506892', 'briefTitle': 'Quantitation of Glymphatic Functioning in Sleep and Meditative States', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Quantitation of Glymphatic Functioning in Sleep and Meditative States', 'orgStudyIdInfo': {'id': 'RFA-AT-21-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adept Meditators', 'description': 'Subjects will undergo scanning during awake, sleep deprived, and meditative states of consciousness.', 'interventionNames': ['Behavioral: Meditation']}], 'interventions': [{'name': 'Meditation', 'type': 'BEHAVIORAL', 'description': 'meditation', 'armGroupLabels': ['Adept Meditators']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212-3160', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Daniel Claassen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Daniel Claassen', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}