Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2026-02-22 @ 3:36 AM
Study NCT ID:
NCT05920759
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2023-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sex-specific Effect of Restricted Sleep on Brain Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002560', 'term': 'Cerebrovascular Circulation'}], 'ancestors': [{'id': 'D001775', 'term': 'Blood Circulation'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2023-06-16', 'studyFirstSubmitQcDate': '2023-06-16', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral blood flow velocity', 'timeFrame': 'Two days', 'description': 'Greater morning cerebral blood flow velocity following a night of normal sleep compared to restricted sleep'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cerebrovascular Circulation']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the impact of restricted sleep on brain blood health in healthy men and women. The main question\\[s\\] it aims to answer are:\n\n* Whether morning cerebral blood flow velocity is greater following a night of normal sleep compared to restricted sleep\n* Whether the effect of sleep restriction on cerebral blood flow will be greater in males compared to females Participants will complete one 1-hour screening visit and two 2.5-hour study visits. Study visits will be conducted on two separate days.', 'detailedDescription': 'Transcranial Doppler (TCD) is a non-invasive diagnostic tool used to estimate cerebral blood flow velocity (CBFV), cerebral autoregulation, cerebrovascular reactivity (CVR), intracranial pressure, cerebral perfusion pressure as well as other indicators of cerebral hemodynamics and autoregulation. Whereas TCD has been widely used in research, clinical, and outpatient settings, studies specifically designed to examine the effect of limited sleep on brain health and potential impact of sex are sparse. Thus, the present study will investigate sex-specific differences in cerebral blood flow under conditions of normal and restricted sleep. Investigators will conduct measures of CBFV and CVR on two separate days under tightly controlled experimental conditions. This study hypothesizes greater morning cerebral blood flow velocity following a night of normal sleep compared to restricted sleep. This study further hypothesize the effect of sleep restriction on CBFV and CVR will be greater in males compared to females. Results from the present study will provide important data necessary to develop future, well-controlled studies examining the impact of long-term modifications in exercise and/or sleep on cerebral hemodynamics and, by extension, risk for cerebrovascular events (i.e. stroke).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult men and women, 18-45 years of age, BMI 18-30 kg/m2, non-pregnant, non-breastfeeding, and non-nicotine users\n\nExclusion Criteria:\n\n* any medications known to affect sleep, autonomic, metabolic, or cardiovascular health, have a self-reported history of hepatic, renal, pulmonary, cardiovascular, or neurological disease, stroke or neurovascular disease, bleeding/clotting disorders, sleep apnea or other sleep disorders, diabetes, history of alcoholism or substance abuse, major cardiovascular event or surgical procedure within the past three months, or hypertension'}, 'identificationModule': {'nctId': 'NCT05920759', 'briefTitle': 'Sex-specific Effect of Restricted Sleep on Brain Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri-Columbia'}, 'officialTitle': 'Sex-specific Effect of Restricted Sleep on Brain Health', 'orgStudyIdInfo': {'id': '2097207'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Normal sleep', 'description': 'Participants will sleep for 7-9 hours the night prior to the study visit.', 'interventionNames': ['Diagnostic Test: Cerebral blood flow']}, {'type': 'EXPERIMENTAL', 'label': 'Restricted sleep', 'description': 'Participants will restrict sleep to four hours the night prior to the study visit.', 'interventionNames': ['Diagnostic Test: Cerebral blood flow']}], 'interventions': [{'name': 'Cerebral blood flow', 'type': 'DIAGNOSTIC_TEST', 'description': 'Transcranial Doppler (TCD) is a non-invasive diagnostic tool used to estimate cerebral blood flow velocity (CBFV), cerebral autoregulation, cerebrovascular reactivity (CVR), intracranial pressure, cerebral perfusion pressure as well as other indicators of cerebral hemodynamics and autoregulation.', 'armGroupLabels': ['Normal sleep', 'Restricted sleep']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65211', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri-Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Interim Chair & Associate Professor', 'investigatorFullName': 'Jill Kanaley', 'investigatorAffiliation': 'University of Missouri-Columbia'}}}}