Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:33 PM
Study NCT ID:
NCT03558893
Status:
COMPLETED
Last Update Posted:
2025-05-15
First Post:
2018-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleep and Circadian Mechanisms of Non-dipping 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': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2018-06-05', 'studyFirstSubmitQcDate': '2018-06-05', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '7-day lab stay', 'description': 'Blood pressure will be measured via automatic and manual-operated sphygmomanometer. Readings will be recorded in units of mmHg.'}, {'measure': 'Heart rate variability', 'timeFrame': '7-day lab stay', 'description': 'Two channel ECG will be recorded for heart rate variability analysis.'}], 'secondaryOutcomes': [{'measure': 'venous epinephrine', 'timeFrame': '7-day lab stay', 'description': 'Venous epinephrine will be measured for adrenal cortex contribution to sympathetic activity.'}, {'measure': 'venous norepinephrine', 'timeFrame': '7-day lab stay', 'description': "venous norepinephrine will be measured for sympathetic nerve activity's contribution to sympathetic activity."}, {'measure': 'saliva cortisol', 'timeFrame': '7-day lab stay', 'description': 'Saliva cortisol will be measured as a sympathetic potentiating hormone.'}, {'measure': 'saliva melatonin', 'timeFrame': '7-day lab stay', 'description': 'saliva melatonin will be measured as a sympathetic attenuating hormone.'}, {'measure': 'venous aldosterone', 'timeFrame': '7-day lab stay', 'description': 'venous aldosterone will be measured as an end point of renin-angiotensin and sympathetic nerve activation'}, {'measure': 'venous endocannabinoids', 'timeFrame': '7-day lab stay', 'description': 'venous endocannabinoids will be measured to estimate stress habituation.'}, {'measure': 'flow mediated dilation', 'timeFrame': '7-day lab stay', 'description': 'Flow mediated dilation will be measured as an indication of endothelial function.'}, {'measure': 'beat-by-beat blood pressure', 'timeFrame': '7-day lab stay', 'description': 'Beat-by-beat Blood Pressure will be measured in the fingers using a non-invasive blood pressure monitoring device.'}, {'measure': '24-hr ambulatory blood pressure', 'timeFrame': '2 day ambulatory period', 'description': 'Ambulatory blood pressure will be measured with an automatic 24-hr blood pressure monitoring device to estimate of blood pressure dipping status.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['circadian rhythm'], 'conditions': ['Hypertension', 'Cardiovascular Risk Factor']}, 'descriptionModule': {'briefSummary': 'This study will be the first to distinguish the relative contributions of sleep, circadian and behavioral mechanisms to the non-dipping BP profile in Black adults and will lay the groundwork for optimizing therapies dependent on mechanisms, such as targeting sleep, targeting circadian rhythmicity, or targeting behaviors, and raising the possibility that ideal therapy for hypertension (HTN) may differ by race. This research will ultimately help to improve health and survival in black populations with HTN.', 'detailedDescription': 'By studying standardized behaviors and regulators of BP during sleep and behavioral stresses across all circadian phases, this protocol will allow us specifically to:\n\n1. To determine if poor sleep, while controlling for circadian phase, contributes to the higher overall BP and reduced nocturnal drop in BP in Blacks compared to Whites.\n2. To determine if reduced BP responses to standardized behavioral changes across the day and night contribute to the higher overall BP and reduced nocturnal drop in BP in Blacks compared to Whites.\n3. To determine if reduced circadian amplitude of BP contributes to the higher overall BP and reduced nocturnal drop in BP in Blacks compared to Whites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Self-identified Black or White\n* 'normotensive' (resting systolic blood pressure (SBP) \\<140/90 mmHg) or uncomplicated stage 1 'hypertensive' (systolic BP between 140 and 160 mmHg or a diastolic (DBP) between 90 and 100 mmHg).\n* free of all prescription and non-prescription drugs (including caffeine, nicotine, alcohol and herbal medications)\n\nExclusion Criteria:\n\n* Currently treated with pharmacologic agents for hypertension\n* Blood pressure \\>160/100 mmHg\n* Smoked within the last year\n* Regular night work or rotating shift work for the three months prior to the study\n* Travel across more than three time zones during the three months prior to the study.\n* Any acute, chronic or debilitating medical conditions, other than mild hypertension (140\\<SBP\\<160 or 90\\<DBP\\<100 mmHg) and severe renal disease (glomerular filtration rate \\<30)\n* Moderate to severe obstructive sleep apnea (OSA)\n* History of severe psychiatric illnesses or psychiatric disorders will be excluded, including alcoholism, drug dependency, major depression, manic depressive illness, schizophrenic disorders, panic disorder, generalized anxiety disorder, post-traumatic stress disorder, agoraphobia, claustrophobia, paranoid personality disorder, schizoid personality disorder, schizotypal personality disorder, borderline personality disorder, and antisocial personality disorder."}, 'identificationModule': {'nctId': 'NCT03558893', 'briefTitle': 'Sleep and Circadian Mechanisms of Non-dipping Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Sleep and Circadian Mechanisms Contributing to Nocturnal Non-dipping Blood Pressure', 'orgStudyIdInfo': {'id': 'IRB 16803'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Forced Desynchrony', 'description': 'All participants will undergo a forced desynchrony protocol.', 'interventionNames': ['Behavioral: Forced Desynchrony']}], 'interventions': [{'name': 'Forced Desynchrony', 'type': 'BEHAVIORAL', 'description': 'All sleep opportunities and other activities will be scheduled by the experimenter so that by the end of the study these activities are spread evenly across all phases of the internal body clock.', 'armGroupLabels': ['Forced Desynchrony']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Steven A Shea, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Steven A. Shea', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}