- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03558893
Health Disparities in Prevalence of Hypertension Between Black and White Americans
July 31, 2023 updated by: Steven A. Shea, Oregon Health and Science University
Sleep and Circadian Mechanisms Contributing to Disparity in Prevalence of Hypertension Between Black and White Americans
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
By studying standardized behaviors and regulators of BP during sleep and behavioral stresses across all circadian phases, this protocol will allow us specifically to:
- 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.
- 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.
- 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.
Study Type
Interventional
Enrollment (Estimated)
52
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicole P Bowles, PhD
- Phone Number: 5034942541
- Email: bowlesn@ohsu.edu
Study Contact Backup
- Name: Latroy Robinson, BS
- Phone Number: 5033463808
- Email: robinlat@ohsu.edu
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health & Science University
-
Contact:
- Nicole P Bowles, PhD
- Phone Number: 503-494-2541
- Email: bowlesn@ohsu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Self-identified Black or White
- '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).
- free of all prescription and non-prescription drugs (including caffeine, nicotine, alcohol and herbal medications)
Exclusion Criteria:
- Currently treated with pharmacologic agents for hypertension
- Blood pressure >160/100 mmHg
- Smoked within the last year
- Regular night work or rotating shift work for the three months prior to the study
- Travel across more than three time zones during the three months prior to the study.
- 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)
- Moderate to severe obstructive sleep apnea (OSA)
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Forced Desynchrony
All participants will undergo a forced desynchrony protocol.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: 7-day lab stay
|
Blood pressure will be measured via automatic and manual-operated sphygmomanometer.
Readings will be recorded in units of mmHg.
|
7-day lab stay
|
Heart rate variability
Time Frame: 7-day lab stay
|
Two channel ECG will be recorded for heart rate variability analysis.
|
7-day lab stay
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
venous epinephrine
Time Frame: 7-day lab stay
|
Venous epinephrine will be measured for adrenal cortex contribution to sympathetic activity.
|
7-day lab stay
|
venous norepinephrine
Time Frame: 7-day lab stay
|
venous norepinephrine will be measured for sympathetic nerve activity's contribution to sympathetic activity.
|
7-day lab stay
|
saliva cortisol
Time Frame: 7-day lab stay
|
Saliva cortisol will be measured as a sympathetic potentiating hormone.
|
7-day lab stay
|
saliva melatonin
Time Frame: 7-day lab stay
|
saliva melatonin will be measured as a sympathetic attenuating hormone.
|
7-day lab stay
|
venous aldosterone
Time Frame: 7-day lab stay
|
venous aldosterone will be measured as an end point of renin-angiotensin and sympathetic nerve activation
|
7-day lab stay
|
venous endocannabinoids
Time Frame: 7-day lab stay
|
venous endocannabinoids will be measured to estimate stress habituation.
|
7-day lab stay
|
flow mediated dilation
Time Frame: 7-day lab stay
|
Flow mediated dilation will be measured as an indication of endothelial function.
|
7-day lab stay
|
beat-by-beat blood pressure
Time Frame: 7-day lab stay
|
Beat-by-beat Blood Pressure will be measured in the fingers using a non-invasive blood pressure monitoring device.
|
7-day lab stay
|
24-hr ambulatory blood pressure
Time Frame: 2 day ambulatory period
|
Ambulatory blood pressure will be measured with an automatic 24-hr blood pressure monitoring device to estimate of blood pressure dipping status.
|
2 day ambulatory period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Steven A Shea, PhD, Ore
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2018
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
July 1, 2025
Study Registration Dates
First Submitted
June 5, 2018
First Submitted That Met QC Criteria
June 5, 2018
First Posted (Actual)
June 15, 2018
Study Record Updates
Last Update Posted (Actual)
August 2, 2023
Last Update Submitted That Met QC Criteria
July 31, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 16803
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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