Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-30 @ 12:42 AM
Study NCT ID:
NCT05656768
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-18
First Post:
2022-11-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep and Circadian Contributions to Nighttime Blood Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-14', 'studyFirstSubmitDate': '2022-11-18', 'studyFirstSubmitQcDate': '2022-12-12', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Melatonin', 'timeFrame': 'Hourly samples obtained over 30 hours', 'description': 'Melatonin levels obtained from saliva samples'}, {'measure': 'Change in Core body temperature', 'timeFrame': 'Continuous measurements over 30 hours', 'description': 'Core body temperature'}], 'secondaryOutcomes': [{'measure': 'Change in Blood pressure', 'timeFrame': 'Measurements obtained every 30 minutes over 30 hours', 'description': 'Systolic and diastolic blood pressure obtained using an ambulatory blood pressure monitor'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sleep', 'circadian rhythm', 'circadian misalignment', 'nocturnal hypertension', 'non-dipping blood pressure'], 'conditions': ['Sleep', 'Circadian Rhythm', 'Blood Pressure', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'Broadly, this study (SCN-BP) seeks to examine sleep and circadian factors that contribute to blood pressure levels at night.', 'detailedDescription': 'SCN-BP is imbedded in a parent grant titled "Improving the Detection of Hypertension (IDH-MEGA)" and examines a variety of sleep (e.g., sleep duration, timing, and the presence of sleep disorder) and circadian factors in Aims 1 and 2. In Aim 3, the investigators will conduct a 30-hour constant routine protocol to directly examine endogenous circadian and blood pressure rhythms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant in the parent grant (IDH-MEGA)\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05656768', 'acronym': 'SCN-BP', 'briefTitle': 'Sleep and Circadian Contributions to Nighttime Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Sleep and Circadian Contributions to Nighttime Blood Pressure', 'orgStudyIdInfo': {'id': 'IRB-300010042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Constant Routine Protocol', 'description': 'Participants complete a 30-hour constant routine protocol to directly examine markers of endogenous circadian rhythms. In a constant routine protocol, participants remain in a dimly lit room (\\<10 lux), in a semi-recumbent posture, remain awake, and consume iso-caloric snacks. Saliva samples are collected and core body temperature and blood pressure are measured.', 'interventionNames': ['Other: Constant Routine Protocol']}], 'interventions': [{'name': 'Constant Routine Protocol', 'type': 'OTHER', 'description': 'A constant routine protocol is used to directly examine markers of circadian rhythmicity (e.g., melatonin and core body temperature). A constant routine protocol requires an individual to remain in a dimly lit room, in a constant semi-recumbent posture, and remain awake for more than 24 hours. It is one of two gold-standard research protocols for examining circadian rhythms in humans.', 'armGroupLabels': ['Constant Routine Protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-0017', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Stephen J Thomas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Stephen Justin Thomas, PhD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}