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Clinical Trials/NCT03558893
NCT03558893
Completed
Not Applicable

Sleep and Circadian Mechanisms Contributing to Nocturnal Non-dipping Blood Pressure

Oregon Health and Science University1 site in 1 country30 target enrollmentDecember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Oregon Health and Science University
Enrollment
30
Locations
1
Primary Endpoint
Blood pressure
Status
Completed
Last Updated
11 months ago

Overview

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: 1. 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. 2. 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. 3. 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.

Registry
clinicaltrials.gov
Start Date
December 1, 2018
End Date
December 31, 2024
Last Updated
11 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steven A. Shea

Director

Oregon Health and Science University

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.

Outcomes

Primary Outcomes

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.

Heart rate variability

Time Frame: 7-day lab stay

Two channel ECG will be recorded for heart rate variability analysis.

Secondary Outcomes

  • saliva cortisol(7-day lab stay)
  • venous norepinephrine(7-day lab stay)
  • venous aldosterone(7-day lab stay)
  • venous endocannabinoids(7-day lab stay)
  • venous epinephrine(7-day lab stay)
  • saliva melatonin(7-day lab stay)
  • beat-by-beat blood pressure(7-day lab stay)
  • 24-hr ambulatory blood pressure(2 day ambulatory period)
  • flow mediated dilation(7-day lab stay)

Study Sites (1)

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