Clinical trial NCT05184933: Sleep and Circadian Mechanisms in Hypertension
Official title: Sleep and Circadian Mechanisms in Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Cardiovascular Diseases
Cardiovascular Risk Factors
Circadian Rhythms
Sleep
Keywords: cardiovascular
circadian rhythms
sleep
blood pressure
constant routine
microneurography
hypertension
sleep regularization
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will complete all parts of the study. The order of completion of the second experiment (Overnight Sleep and Rested Wakefulness trials) will be randomized.
Primary purpose: OTHER

Brief summary: This study is a mechanistic clinical trial designed to investigate the effects of the circadian system and sleep on non-dipping blood pressure (BP) in people with hypertension (HTN).

Detailed description: This study is a mechanistic clinical trial designed to study the effects of the circadian system and sleep on non-dipping blood pressure (BP) in people with hypertension (HTN). Investigators will study participants with dipping and non-dipping hypertension. All participants will partake in all experiments. First, investigators will assess sleep in the participants' home environment using unattended polysomnography. Participants will then complete a 5-day overnight forced desynchrony laboratory protocol to uncover circadian rhythms (Constant Routine). The second experiment is a randomized crossover protocol. Two trials (Overnight Sleep and Rested Wakefulness) will be completed in randomized order to separate the effects of sleep on non-dipping blood pressure while assessing nighttime cardiovascular mechanisms. Finally, investigators will pilot test if 2 weeks of sleep regularization impacts 24-hour BP.

Eligibility criteria: Inclusion Criteria:

* Ages 25-64
* BMI 18.5-42kg/m2
* Hypertension (average resting blood pressure between 130/80 mmHg and 160/100 mmHg)

Exclusion Criteria:

* Over 5 pack-years of smoking;
* Prior shift work within 12 months prior to the study;
* Travel greater than three time zones for at least 3 months;
* History of heart failure, cardiomyopathy, or history of bypass surgery, angioplasty, or previous myocardial infarction;
* Acute or chronic diseases (except hypertension) that may affect outcome measures;
* History of psychological conditions;
* Sleep disorders, like severe sleep apnea, insomnia, etc.;
* Prescription medications (Contraceptives and anti-hypertensive medications are permissible);
* History of Illicit drug use and alcohol dependency;
* 30 days free of cannabis use prior to the study;
* Pregnancy;
* Upper cut-off of 160/100 mmHg for BP

Primary outcomes:
measure: Sleep duration (At-home Polysomnography)
timeFrame: 1-2 nights
measure: Sleep Episodes (At-home Polysomnography)
timeFrame: 1-2 nights
measure: Blood pressure (Circadian and Overnight sleep vs. rested wakefulness trial)
timeFrame: 7 days
measure: Heart rate (Circadian and Overnight sleep vs. rested wakefulness trial)
timeFrame: 7 days
measure: Heart rate variability (Circadian and Overnight sleep vs. rested wakefulness trial)
timeFrame: 7 days
measure: Epinephrine (Circadian and Overnight sleep vs. rested wakefulness trial)
timeFrame: 7 days
measure: Norepinephrine (Circadian and Overnight sleep vs. rested wakefulness trial)
timeFrame: 7 days
measure: Aldosterone (Circadian and Overnight sleep vs. rested wakefulness trial)
timeFrame: 7 days
measure: Renin (Circadian and Overnight sleep vs. rested wakefulness trial)
timeFrame: 7 days
measure: Vascular endothelial function (Circadian and Overnight sleep vs. rested wakefulness trial)
timeFrame: 7 days
measure: Magnitude of overnight blood pressure dipping (Overnight sleep vs. rested wakefulness trial)
timeFrame: 2 days
measure: Muscle sympathetic nerve activity (MSNA) (Overnight sleep vs. rested wakefulness trial and circadian trial)
timeFrame: 7 days
Secondary outcomes:
measure: Ambulatory blood pressure (Sleep regularization trial)
timeFrame: 2 weeks
measure: Blood pressure dipping status (Sleep regularization trial)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Saurabh S Thosar, PhD
role: PRINCIPAL_INVESTIGATOR
References: