Sleep and Circadian Mechanisms of Non-dipping Blood Pressure

NCT ID: NCT03558893

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2024-12-31

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.

Conditions

Hypertension; Cardiovascular Risk Factor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Forced Desynchrony

All participants will undergo a forced desynchrony protocol.

Group Type: EXPERIMENTAL

Forced Desynchrony

Intervention Type: BEHAVIORAL

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.

Interventions

Forced Desynchrony

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Steven A. Shea

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven A Shea, PhD

Role: PRINCIPAL_INVESTIGATOR

Ore

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

IRB 16803

Identifier Type: -

Identifier Source: org_study_id