Clinical trial NCT03558893: Sleep and Circadian Mechanisms of Non-dipping Blood Pressure
Official title: Sleep and Circadian Mechanisms Contributing to Nocturnal Non-dipping Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiovascular Risk Factor
Keywords: circadian rhythm
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Blood pressure
timeFrame: 7-day lab stay
measure: Heart rate variability
timeFrame: 7-day lab stay
Secondary outcomes:
measure: venous epinephrine
timeFrame: 7-day lab stay
measure: venous norepinephrine
timeFrame: 7-day lab stay
measure: saliva cortisol
timeFrame: 7-day lab stay
measure: saliva melatonin
timeFrame: 7-day lab stay
measure: venous aldosterone
timeFrame: 7-day lab stay
measure: venous endocannabinoids
timeFrame: 7-day lab stay
measure: flow mediated dilation
timeFrame: 7-day lab stay
measure: beat-by-beat blood pressure
timeFrame: 7-day lab stay
measure: 24-hr ambulatory blood pressure
timeFrame: 2 day ambulatory period
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Ore
name: Steven A Shea, PhD
role: PRINCIPAL_INVESTIGATOR
References: