Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-26 @ 6:27 PM
Study NCT ID:
NCT04583033
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2020-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Well for Healthy Brain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2020-10-06', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of brain tissue volume loss in specific brain regions', 'timeFrame': 'Year 2', 'description': 'As evaluated from the Magnetic Resonance Imaging (MRI) Brain scan'}], 'secondaryOutcomes': [{'measure': 'Cognitive Performance', 'timeFrame': 'Year 2', 'description': 'Cognitive performance will be assessed using a Memory test which has a composite score ranging from 80 to 120 % with a higher score indicating better performance and a midrange at 100%.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Poor Quality Sleep']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to slow down the aging of the participant's brain by improving sleep quality."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English-speaking healthy subjects age 55 years and older capable and willing to consent to participate in the study. In addition, subject should be cognitively normal and have well documented sleep issues that results with poor sleep quality based on self-reported assessment.\n\nExclusion Criteria:\n\n* pregnant women\n* cognitively impaired subjects not able to provide consent\n* prisoners\n* Subjects 55 years of age and older that meet criteria for mild cognitive impairment.\n* Subjects with any neurological disorder.\n* Any other condition that in the opinion of the investigator may affect the participation in this study'}, 'identificationModule': {'nctId': 'NCT04583033', 'briefTitle': 'Sleep Well for Healthy Brain', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': "Lifestyle Stressors of Hippocampus and Alzheimer's Disease (AD) Related Brain Regions: Potential for Intervention", 'orgStudyIdInfo': {'id': '20201031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral Therapy (CBT) Group', 'description': 'Participants will receive CBT intervention bi-weekly for total of six (6) sessions.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy (CBT)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants will not receive any intervention as part of the study.'}], 'interventions': [{'name': 'Cognitive Behavioral Therapy (CBT)', 'type': 'BEHAVIORAL', 'description': 'Treatment components include stimulus control, sleep restriction therapy, relaxation, and cognitive therapy. Each session will last approximately one hour and will be provided on line.', 'armGroupLabels': ['Cognitive Behavioral Therapy (CBT) Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Noam Alperin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'collaborators': [{'name': 'Florida Department of Health', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Noam Alperin', 'investigatorAffiliation': 'University of Miami'}}}}