Sleep Enhancement and Health Education for High Blood Pressure

Overseen By Madeline Reid

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Antihypertensives

Must not be taking: Sleep aids

Disqualifiers: Cardiovascular, Diabetes, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Hypertension is the major risk factor for cardiovascular and cerebrovascular diseases worldwide. The escalating prevalence of inadequate sleep now parallels that of hypertension. Observational and experimental evidence favoring a causal relation between insufficient sleep and hypertension are particularly compelling - sleeping 6 hours or less per night is associated with a 20-32% higher probability of incident hypertension. Since sleep curtailment is largely voluntary, sleep deficiency may be corrected and the detrimental health consequences potentially reversed. In this study the investigators aim to investigate 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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on prescription medications for chronic conditions, you must have been on a stable regimen for at least one month before joining the study.

Is the Sleep Enhancement and Health Education treatment safe for humans?

The use of educational materials for health education, such as booklets, has been shown to increase knowledge and motivation without causing adverse psychological effects, suggesting they are generally safe for humans. ^{1 2 3 4 5}

How does the Sleep Enhancement and Health Education treatment for high blood pressure differ from other treatments?

This treatment is unique because it focuses on increasing sleep duration as a behavioral strategy to lower blood pressure, rather than relying on medication. By extending sleep, it aims to naturally reduce blood pressure, which is different from traditional drug-based approaches. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Sleep Enhancement and Health Education for High Blood Pressure?

Research shows that health education can significantly improve blood pressure control and medication adherence in patients with high blood pressure. Educational programs have been effective in helping patients manage their condition better, leading to improved health outcomes. ^{11 12 13 14 15}

Who Is on the Research Team?

Virend Somers, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion 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.

My gender does not affect my eligibility.

Exclusion Criteria

Current or previous (during the past 2 months) participation in other research studies at the discretion of study personnel

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 8 weeks of sleep enhancement/extension or health education

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Health Education
• Sleep Enhancement

Trial Overview 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.

How Is the Trial Designed?

Group I: Sleep Enhancement Experimental Treatment 1 Intervention

Group II: Health Education Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The educational interventions significantly improved blood pressure control in ambulatory patients, with the proportion of patients achieving controlled blood pressure increasing from 38% to 66%.

In contrast, the control group receiving standard medical therapy without educational support showed no change in blood pressure control, remaining at 42%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health education for hypertensive patients. Levine, DM., Green, LW., Deeds, SG., et al.[2016]

An educational program for hypertensive patients after a stroke significantly improved their knowledge about their condition, with correct response rates increasing from 77.9% to 94.1% after the intervention.

The program also led to better medication adherence and more frequent self-measurement of blood pressure, indicating that education can play a crucial role in managing health post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a hypertension-based patient education program in a stroke center. Ben Nasr, N., Rouault, A., Cornillet, N., et al.[2021]

Educating cancer patients about their condition and treatment can enhance their autonomy and improve treatment compliance, leading to better overall care during complex and long-term therapies.

This education should be supported by well-trained practitioners and include written and video resources, with a focus on evaluating its effectiveness and cost-benefit to ensure improvements in treatment quality and patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Education of cancer patients]. Hoerni, B., Soubeyran, P.[2017]

An internet-based reporting system was developed to help healthcare professionals, particularly pharmacists, report dietary supplement-related adverse events, addressing the issue of underreporting due to lack of awareness and time constraints.

The system not only facilitated the collection of DS-related events but also provided educational resources, which increased engagement and awareness among healthcare professionals regarding the safety of dietary supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Collecting and sharing information about dietary supplements and functional foods among healthcare professionals using internet-based system]. Asahina, Y., Hori, S., Sawada, Y.[2019]

An interactive booklet was created to help patients understand the benefits and risks of antihypertensive drugs, aiming to prevent adverse drug events, which affect 25% of patients and can have severe consequences in 13% of cases.

The development process involved input from 27 experts and feedback from patients and healthcare providers, ensuring the booklet is user-friendly and addresses patient concerns about the expected benefits of antihypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Information and active patient participation using an interactive booklet in the prescription of antihypertensive drugs in primary care]. Keriel-Gascou, M., Badet-Phan, A., Le Pogam, MA., et al.[2014]

A study involving 1,000 elderly individuals in Denmark found that while general knowledge about blood pressure and hypertension was reasonable, many still lacked critical awareness, such as the fact that hypertension can occur without symptoms.

Interestingly, individuals with self-reported hypertension showed greater awareness of blood pressure issues, but overall knowledge about hypertension was not significantly better among them, indicating a need for improved education on the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported knowledge and awareness about blood pressure and hypertension: a cross-sectional study of a random sample of men and women aged 60-74 years. Qvist, I., Thomsen, MD., Lindholt, JS., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Health education for hypertensive patients. [2016]

2. Ireland pubmed.ncbi.nlm.nih.gov

Arterial hypertension: lessons from patient education. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Assessing the impact of educational intervention in patients with hypertension. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a hypertension-based patient education program in a stroke center. [2021]

5. France pubmed.ncbi.nlm.nih.gov

[Education of cancer patients]. [2017]

6. Japan pubmed.ncbi.nlm.nih.gov

[Collecting and sharing information about dietary supplements and functional foods among healthcare professionals using internet-based system]. [2019]

7. France pubmed.ncbi.nlm.nih.gov

[Information and active patient participation using an interactive booklet in the prescription of antihypertensive drugs in primary care]. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Weight reduction in the prevention and treatment of hypertension: a review of representative clinical trials. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Education of the hypertensive patient: the Ann Arbor approach. [2007]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Self-reported knowledge and awareness about blood pressure and hypertension: a cross-sectional study of a random sample of men and women aged 60-74 years. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Increasing sleep duration to lower beat-to-beat blood pressure: a pilot study. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Association between sleep duration and high blood pressure in adolescents: a systematic review and meta-analysis. [2019]

13. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of Mid-Day Sleep on blood pressure levels in patients with arterial hypertension. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Ambulatory blood pressure and cardiovascular outcome in relation to perceived sleep deprivation. [2016]

15. England pubmed.ncbi.nlm.nih.gov

The "Hypertension Approaches in the Elderly: a Lifestyle study" multicenter, randomized trial (HAEL Study): rationale and methodological protocol. [2023]