NCT03558893

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

6.1 years

First QC Date

June 5, 2018

Last Update Submit

May 12, 2025

Conditions

HypertensionCardiovascular Risk Factor

Keywords

circadian rhythm

Outcome Measures

Primary Outcomes (2)

  • Blood pressure

    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

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

    7-day lab stay

Secondary Outcomes (9)

  • venous epinephrine

    7-day lab stay

  • venous norepinephrine

    7-day lab stay

  • saliva cortisol

    7-day lab stay

  • saliva melatonin

    7-day lab stay

  • venous aldosterone

    7-day lab stay

  • +4 more secondary outcomes

Study Arms (1)

Forced Desynchrony

EXPERIMENTAL

All participants will undergo a forced desynchrony protocol.

Behavioral: Forced Desynchrony

Interventions

Forced DesynchronyBEHAVIORAL

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.

Forced Desynchrony

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Steven A Shea, PhD

    Ore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

June 5, 2018

First Posted

June 15, 2018

Study Start

December 1, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

May 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)