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Sleep Enhancement and Health Education for High Blood Pressure
N/A
Waitlist Available
Led By Virend Somers, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: 18 to 65 (inclusive)
Be older than 18 years old
Must not have
Travel across >2 time zones in the previous month
Severe daytime sleepiness (score >15 at the Epworth Sleepiness Scale)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Summary
This trial will compare the effects of 8 weeks of sleep enhancement/extension vs health education in prehypertensive and stage 1 hypertensive subjects who report habitual short sleep (≤6.5 hours/night).
Who is the study for?
This trial is for adults aged 18-65 with prehypertension or stage 1 hypertension who usually sleep less than 7 hours a night. They should not be on varying medications, pregnant, breastfeeding, smoking, or have serious health issues like heart disease or diabetes. Participants must also not consume excessive alcohol or caffeine.
What is being tested?
The study compares the effects of an 8-week program focused on improving sleep habits versus providing health education to individuals with high blood pressure who typically don't get enough sleep.
What are the potential side effects?
Since the interventions involve non-pharmaceutical measures (sleep enhancement and health education), significant side effects are not anticipated. However, changes in sleep patterns can sometimes affect mood and alertness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not traveled across more than 2 time zones in the last month.
Select...
I often feel very sleepy during the day.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
change in 48-hour mean arterial pressure
Secondary study objectives
changes in 48-hour heart rate
changes in aldosterone
changes in angiotensin peptides
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sleep EnhancementExperimental Treatment1 Intervention
Group II: Health EducationPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,792,266 Total Patients Enrolled
Mayo ClinicLead Sponsor
3,341 Previous Clinical Trials
3,062,177 Total Patients Enrolled
Virend Somers, MD, PhDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital-Rochester Saint Marys Campus
9 Previous Clinical Trials
5,320 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood pressure is high or I am on medication for it.I am not on any prescription meds except for birth control, or my chronic condition meds have been stable for 1 month.I have a heart condition, diabetes, kidney disease, cancer, sleep disorders, or mental health issues.You drink more than 14 alcoholic drinks per week (if you're a man) or more than 7 drinks per week (if you're a woman), or you consume more than 400 mg of caffeine.You are a smoker.My chronic condition medication hasn't changed in the last month.My gender does not affect my eligibility.I am between 18 and 65 years old.If you work at night or have irregular work hours.I have not traveled across more than 2 time zones in the last month.I use medication to help me sleep.You usually sleep for at least 7 hours.You are currently on a diet or trying to lose weight.You have a history of falling asleep while driving.I often feel very sleepy during the day.You have donated blood or plasma in the last 2 months.You are not able or willing to change your sleep schedule.Your body mass index (BMI) is between 18.5 and 34.9.I usually sleep less than 7 hours but sleep more when I can.You do not currently smoke or use any tobacco products.
Research Study Groups:
This trial has the following groups:- Group 1: Sleep Enhancement
- Group 2: Health Education
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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