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Sleep Enhancement and Health Education for High Blood Pressure

N/A

Recruiting

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

Presence of prehypertension (office systolic BP (SBP) 120-139 mmHg and/or diastolic BP (DBP) 80-89 mmHg), Stage 1 hypertension (office SBP 140-159 mmHg and/or DBP 90-99 mmHg), or currently taking antihypertensive medications

Either on no prescription medications (other than oral contraceptive pills, or intrauterine devices) or on stable medical regimen for at least 1 month, if taking prescription medications for chronic conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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My blood pressure is high or I am on medication for it.

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I am not on any prescription meds except for birth control, or my chronic condition meds have been stable for 1 month.

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My gender does not affect my eligibility.

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I am between 18 and 65 years old.

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I usually sleep less than 7 hours but sleep more when I can.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

change in 48-hour mean arterial pressure

Secondary outcome measures

changes in 48-hour heart rate

changes in aldosterone

changes in angiotensin peptides

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Sleep EnhancementExperimental Treatment1 Intervention

Group II: Health EducationPlacebo Group1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,834 Previous Clinical Trials

47,310,555 Total Patients Enrolled

Mayo ClinicLead Sponsor

3,206 Previous Clinical Trials

3,767,003 Total Patients Enrolled

Virend Somers, MD, PhDPrincipal Investigator - Mayo Clinic

Mayo Clinic Hospital-Rochester Saint Marys Campus

9 Previous Clinical Trials

5,310 Total Patients Enrolled

Media Library

Health Education Clinical Trial Eligibility Overview. Trial Name: NCT03255746 — N/A

High Blood Pressure Research Study Groups: Sleep Enhancement, Health Education

High Blood Pressure Clinical Trial 2023: Health Education Highlights & Side Effects. Trial Name: NCT03255746 — N/A

Health Education 2023 Treatment Timeline for Medical Study. Trial Name: NCT03255746 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any restrictions on who may participate in this research project?

"This clinical trial is seeking 94 participants aged 18 - 65 who suffer from hypertension. Essential criteria for qualification include gender, BMI, habitual sleep duration and abstention from smoking or tobacco use. Additionally, applicants must not be pregnant or breastfeeding nor taking any medications (except contraceptives) or on a consistent medical regime for at least 1 month prior to the start of the study."

Answered by AI

Is the eligibility criterion for this trial inclusive of individuals over 40 years old?

"Per the outlined requirements, individuals between 18 and 65 years of age are eligible to take part in this clinical trial. There are 54 studies involving patients younger than 18 and 665 for those over 65."

Answered by AI

What is the upper limit to the number of participants in this medical study?

"Affirmative. According to the information on clinicaltrials.gov, recruitment for this experimental study is still ongoing; it was initially posted on April 19th 2018 and last updated on July 28th 2022. 94 individuals need to be enrolled at a single medical facility."

Answered by AI

Is this examination open to further enrollment?

"Affirmative. Clinicaltrials.gov states that this clinical trial is actively recruiting participants and was initially posted on April 19th 2018, with the most recent update being made on July 28th 2022. The team behind the study needs to enlist 94 patients from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HELP-HY: Health Education and sLeep Program in HYpertension

Virend Somers, MD, PhD 2018. "HELP-HY: Health Education and sLeep Program in HYpertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03255746.

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