Sleep and Circadian Mechanisms in Hypertension

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Hypertension; Cardiovascular Diseases; Cardiovascular Risk Factors; Circadian Rhythms; Sleep

Treatments: Other: At-home Polysomnography; Behavioral: Regularized Sleep Schedule; Other: Rested Wakefulness Trial; Other: Overnight Sleep Trial; Other: Circadian Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT05184933

IRB00023776

Details and patient eligibility

About

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).

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 25 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Dipping vs non-dipping HTN

Experimental group

Description:

Participants will wear an ambulatory blood pressure monitor (SpaceLabs, Inc.) which will take their blood pressure in 20-30-minute intervals for 24-48 hours to determine blood pressure dipping status. All participants in this arm will complete the experiments in this order: 1. At-home polysomnography; 2. Constant Routine protocol; 3. Rested Wakefulness Trial AND Overnight Sleep Trial (Randomized crossover); 4. Sleep Regularization Trial

Treatment:

Other: Circadian Protocol

Other: Overnight Sleep Trial

Other: Rested Wakefulness Trial

Behavioral: Regularized Sleep Schedule

Other: At-home Polysomnography