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Sleep and Circadian Interventions for High Blood Pressure

N/A

Recruiting

Led By Saurabh S Thosar, PhD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 25-64

Be between 18 and 65 years old

Must not have

Sleep disorders, like severe sleep apnea, insomnia, etc.

History of heart failure, cardiomyopathy, or history of bypass surgery, angioplasty, or previous myocardial infarction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-2 nights

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how sleep and the body's natural 24-hour clock affects blood pressure in people with hypertension.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive monitoring rather than medication or invasive procedures, side effects are minimal but may include discomfort from wearing monitoring equipment during sleep studies or potential disruption of normal sleeping patterns due to the regularized schedule.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 25 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a severe sleep disorder.

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I have a history of heart issues, including heart failure or surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-2 nights

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-2 nights

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 nights for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aldosterone (Circadian and Overnight sleep vs. rested wakefulness trial)

Blood pressure (Circadian and Overnight sleep vs. rested wakefulness trial)

Epinephrine (Circadian and Overnight sleep vs. rested wakefulness trial)

+9 more

Secondary study objectives

Ambulatory blood pressure (Sleep regularization trial)

Blood pressure dipping status (Sleep regularization trial)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dipping vs non-dipping HTNExperimental Treatment5 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

0 / 3Eligibility criteria met