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Health Disparities in Prevalence of Hypertension Between Black and White Americans

Primary Purpose

Hypertension, Cardiovascular Risk Factor

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Forced Desynchrony
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension focused on measuring circadian rhythm

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Oregon Health & Science UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Forced Desynchrony

Arm Description

All participants will undergo a forced desynchrony protocol.

Outcomes

Primary Outcome Measures

Blood pressure
Blood pressure will be measured via automatic and manual-operated sphygmomanometer. Readings will be recorded in units of mmHg.
Heart rate variability
Two channel ECG will be recorded for heart rate variability analysis.

Secondary Outcome Measures

venous epinephrine
Venous epinephrine will be measured for adrenal cortex contribution to sympathetic activity.
venous norepinephrine
venous norepinephrine will be measured for sympathetic nerve activity's contribution to sympathetic activity.
saliva cortisol
Saliva cortisol will be measured as a sympathetic potentiating hormone.
saliva melatonin
saliva melatonin will be measured as a sympathetic attenuating hormone.
venous aldosterone
venous aldosterone will be measured as an end point of renin-angiotensin and sympathetic nerve activation
venous endocannabinoids
venous endocannabinoids will be measured to estimate stress habituation.
flow mediated dilation
Flow mediated dilation will be measured as an indication of endothelial function.
beat-by-beat blood pressure
Beat-by-beat Blood Pressure will be measured in the fingers using a non-invasive blood pressure monitoring device.
24-hr ambulatory blood pressure
Ambulatory blood pressure will be measured with an automatic 24-hr blood pressure monitoring device to estimate of blood pressure dipping status.

Full Information

First Posted
June 5, 2018
Last Updated
July 31, 2023
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT03558893
Brief Title
Health Disparities in Prevalence of Hypertension Between Black and White Americans
Official Title
Sleep and Circadian Mechanisms Contributing to Disparity in Prevalence of Hypertension Between Black and White Americans
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Cardiovascular Risk Factor
Keywords
circadian rhythm

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Forced Desynchrony
Arm Type
Experimental
Arm Description
All participants will undergo a forced desynchrony protocol.
Intervention Type
Behavioral
Intervention Name(s)
Forced Desynchrony
Intervention 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.
Primary Outcome Measure Information:
Title
Blood pressure
Description
Blood pressure will be measured via automatic and manual-operated sphygmomanometer. Readings will be recorded in units of mmHg.
Time Frame
7-day lab stay
Title
Heart rate variability
Description
Two channel ECG will be recorded for heart rate variability analysis.
Time Frame
7-day lab stay
Secondary Outcome Measure Information:
Title
venous epinephrine
Description
Venous epinephrine will be measured for adrenal cortex contribution to sympathetic activity.
Time Frame
7-day lab stay
Title
venous norepinephrine
Description
venous norepinephrine will be measured for sympathetic nerve activity's contribution to sympathetic activity.
Time Frame
7-day lab stay
Title
saliva cortisol
Description
Saliva cortisol will be measured as a sympathetic potentiating hormone.
Time Frame
7-day lab stay
Title
saliva melatonin
Description
saliva melatonin will be measured as a sympathetic attenuating hormone.
Time Frame
7-day lab stay
Title
venous aldosterone
Description
venous aldosterone will be measured as an end point of renin-angiotensin and sympathetic nerve activation
Time Frame
7-day lab stay
Title
venous endocannabinoids
Description
venous endocannabinoids will be measured to estimate stress habituation.
Time Frame
7-day lab stay
Title
flow mediated dilation
Description
Flow mediated dilation will be measured as an indication of endothelial function.
Time Frame
7-day lab stay
Title
beat-by-beat blood pressure
Description
Beat-by-beat Blood Pressure will be measured in the fingers using a non-invasive blood pressure monitoring device.
Time Frame
7-day lab stay
Title
24-hr ambulatory blood pressure
Description
Ambulatory blood pressure will be measured with an automatic 24-hr blood pressure monitoring device to estimate of blood pressure dipping status.
Time Frame
2 day ambulatory period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicole P Bowles, PhD
Phone
5034942541
Email
bowlesn@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Latroy Robinson, BS
Phone
5033463808
Email
robinlat@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A Shea, PhD
Organizational Affiliation
Ore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole P Bowles, PhD
Phone
503-494-2541
Email
bowlesn@ohsu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Health Disparities in Prevalence of Hypertension Between Black and White Americans

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