Sleep and Circadian Interventions for High Blood Pressure

Overseen By Saurabh S Thosar, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must be taking: Anti-hypertensive

Must not be taking: Prescription medications

Disqualifiers: Heart failure, Psychological conditions, Sleep disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a regular sleep schedule might affect blood pressure patterns in individuals with high blood pressure. Researchers aim to determine if sleep can help manage "non-dipping," a condition where blood pressure doesn’t drop at night as expected. Participants will follow a structured sleep routine and have their blood pressure monitored over several days. This trial suits individuals with high blood pressure readings typically between 130/80 mmHg and 160/100 mmHg. As an unphased trial, it offers participants the chance to contribute to valuable research that could provide new insights into managing high blood pressure.

Will I have to stop taking my current medications?

The trial allows participants to continue taking contraceptives and anti-hypertensive medications, so you may not need to stop these. However, other prescription medications are not permitted.

What prior data suggests that these sleep and circadian interventions are safe for people with hypertension?

Research has shown that the treatments in this study are generally safe for participants. The at-home sleep study, for instance, is designed to be user-friendly and monitors key indicators like breathing and heart rate. It is a common method for identifying sleep problems and is typically comfortable for patients.

Studies have found that maintaining a regular sleep schedule can help lower blood pressure and reduce the risk of heart disease, while irregular sleep patterns are linked to higher blood pressure. Regularizing sleep is a safe and non-invasive approach.

For the overnight sleep trial, negative effects are rare. A review found only one issue for every 623 tests conducted in sleep centers, indicating that overnight sleep studies are safe for participants.

The Rested Wakefulness Test, which measures alertness, is also safe. It is commonly used to assess sleepiness without significant negative effects reported.

Overall, these methods are non-invasive and have a strong safety record based on past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the regularized sleep schedule because it offers a non-drug approach to managing high blood pressure. Unlike typical medications that aim to lower blood pressure chemically, this method focuses on aligning the body's natural sleep-wake cycle to potentially improve heart health. By examining the effects of consistent sleep patterns, this trial explores how lifestyle changes can complement or even reduce the need for traditional hypertension medications. This innovative approach is particularly appealing as it could offer a side-effect-free option for patients.

What evidence suggests that this trial's treatments could be effective for high blood pressure?

Research has shown that maintaining a regular sleep schedule, which participants in this trial will follow, can help lower high blood pressure. People without regular sleep patterns are more likely to develop high blood pressure compared to those with consistent routines. Studies have also found that a consistent sleep routine can reduce the risk of heart disease. Other research suggests that regular sleep patterns might be even more crucial for health than simply getting enough sleep each night. Overall, maintaining a regular sleep schedule appears to be a promising way to manage blood pressure and support heart health. ^{1 2 6 7 8}

Who Is on the Research Team?

Saurabh S Thosar, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for adults aged 25-64 with a BMI of 18.5-42kg/m2 and hypertension, having an average resting BP between 130/80 mmHg and 160/100 mmHg. Excluded are heavy smokers, recent shift workers, frequent travelers across time zones, those on certain meds or with drug/alcohol issues, pregnant women, individuals with severe cardiovascular or psychological conditions, and those with serious sleep disorders.

Inclusion Criteria

I am between 25 and 64 years old.

Your body mass index (BMI) is between 18.5 and 42.

My average blood pressure is between 130/80 and 160/100.

Exclusion Criteria

You have not used cannabis for 30 days before the study.

I have a severe sleep disorder.

You have worked night shifts in the past year before the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

At-home Polysomnography

Participants undergo sleep assessment in their home environment using unattended polysomnography

1-2 nights

1 visit (in-person)

Constant Routine Protocol

Participants complete a 5-day overnight forced desynchrony laboratory protocol to uncover circadian rhythms

5 days

Randomized Crossover Trials

Participants complete Overnight Sleep and Rested Wakefulness trials in randomized order to assess nighttime cardiovascular mechanisms

7 days

Sleep Regularization Trial

Participants adhere to a regular sleep schedule for 2 weeks to assess its impact on 24-hour blood pressure

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after the completion of trials

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• At-home Polysomnography
• Circadian Protocol
• Overnight Sleep Trial
• Regularized Sleep Schedule
• Rested Wakefulness Trial

Trial Overview

The study examines how the body's circadian rhythm (24-hour cycle) and sleep quality affect blood pressure in hypertensive patients. Participants will undergo various trials including a Circadian Protocol to assess their natural rhythms, Overnight Sleep Trial monitored by polysomnography at home to evaluate sleep patterns, Rested Wakefulness Trial to observe alertness levels after restful sleep, and adherence to a Regularized Sleep Schedule.

How Is the Trial Designed?

Group I: Dipping vs non-dipping HTN Experimental Treatment 5 Interventions

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

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

In a study of 1720 adults, irregular sleep patterns, specifically a standard deviation of sleep duration greater than 90 minutes over a week, were linked to a higher prevalence of hypertension (HTN) and elevated blood pressure (BP) levels.

Participants without obstructive sleep apnea (OSA) who had significant sleep irregularity were found to have a 48% increased likelihood of having hypertension, highlighting the importance of consistent sleep duration for cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep irregularity and the association with hypertension and blood pressure levels: the ELSA-Brasil study. Parise, BK., Santos, RB., Mesas, AE., et al.[2023]

Using arbitrary times for defining awake and sleep periods in hypertension studies does not significantly change the average blood pressure readings, but it can lead to substantial differences in individual measurements, especially during sleep.

In about 20% to 30% of subjects, the choice of time schedule can alter sleep blood pressure loads by more than 10%, indicating that using actual patient-reported times is crucial for accurate assessment in 24-hour blood pressure monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of actual versus arbitrary awake and sleep times on analyses of 24-h blood pressure. Peixoto Filho, AJ., Mansoor, GA., White, WB.[2009]

The study analyzed blood pressure (BP) rhythms in 378 subjects, revealing that sleep-time hypertensive individuals have lower 24-hour and 12-hour BP rhythm amplitude and integrity compared to awake-time hypertensives, indicating a disorganized circadian rhythm.

This disorganization in BP rhythms among sleep-time hypertensives may be linked to increased cardiovascular risk, highlighting the importance of monitoring BP patterns during both awake and sleep periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blunting of circadian rhythms and increased acrophase variability in sleep-time hypertensive subjects. Perez-Lloret, S., Risk, M., Golombek, DA., et al.[2008]

Tailoring antihypertensive treatment based on an individual's circadian blood pressure pattern can enhance efficacy and reduce side effects, as shown with medications like nifedipine GITS and valsartan.

Bedtime dosing of certain antihypertensives, such as valsartan, not only improves blood pressure control but also lowers urinary albumin excretion, indicating better kidney protection and overall cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronotherapy of hypertension: administration-time-dependent effects of treatment on the circadian pattern of blood pressure. Hermida, RC., Ayala, DE., Calvo, C., et al.[2008]

Adequate quality sleep is linked to lower blood pressure and may help prevent and treat hypertension, as shown by various studies including experimental, epidemiological, and interventional research.

Short sleep duration is associated with higher blood pressure, particularly in middle-aged adults and women, suggesting that improving sleep quality and duration could be an effective strategy for managing hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of evidence for the link between sleep duration and hypertension. Gangwisch, JE.[2022]

Blood pressure (BP) typically follows a daily pattern, rising during late sleep and peaking in the morning, influenced by various environmental and behavioral factors more than circadian rhythms.

In patients with secondary hypertension, a lack of nighttime BP reduction is observed, and taking long-acting medications at bedtime rather than in the morning leads to better control of hypertension and reduced vascular risk, highlighting the importance of timing in medication administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian mechanisms of 24-hour blood pressure regulation and patterning. Smolensky, MH., Hermida, RC., Portaluppi, F.[2018]

In a study of nine shift workers, blood pressure (BP) and heart rate (HR) were monitored over 24 hours, revealing that BP was significantly lower during night shifts compared to day shifts, indicating a disruption in normal circadian rhythms.

The findings suggest that individuals working night shifts experience incomplete adaptation to their work hours, which may necessitate adjustments in hypertension treatment to account for altered BP patterns during sleep and work periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Arterial pressure and shift work activities]. Mallion, JM., de Gaudemaris, R., Monzie, A., et al.[2009]

Blunted blood pressure decline during sleep is linked to a higher risk of cardiovascular events, highlighting the importance of managing blood pressure effectively at night.

Taking blood pressure medications like ACE inhibitors and ARBs in the evening rather than the morning can lead to better control of nighttime blood pressure and improve overall cardiovascular health, suggesting that aligning treatment with the body's natural rhythms (chronotherapy) is beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian rhythms in blood pressure regulation and optimization of hypertension treatment with ACE inhibitor and ARB medications. Hermida, RC., Ayala, DE., Fernández, JR., et al.[2011]

In a study analyzing 26,170 ambulatory blood pressure monitoring (ABPM) recordings, it was found that 43% of patients, including those with normal blood pressure, exhibited non-dipping patterns, indicating a potential risk for cardiovascular issues.

Age and body mass index (BMI) were significant factors influencing blood pressure patterns, with older patients and those with a BMI over 30 showing higher rates of non-dipping, which could affect their overall cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory blood pressure monitoring profiles in a cross-sectional analysis of a large database of normotensive and true or suspected hypertensive patients. Araújo, S., Rouxinol-Dias, A., Mesquita-Bastos, J., et al.[2021]

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