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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether more sleep can help individuals with high blood pressure (hypertension) improve their health. Researchers aim to determine if longer sleep is as effective as health education for those who typically sleep less than 6.5 hours a night. Suitable candidates for this trial include individuals with slightly elevated blood pressure who often catch up on sleep during weekends or holidays. As an unphased trial, this study offers a unique opportunity to contribute to understanding sleep's impact on hypertension.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that insufficient sleep links to high blood pressure. People who sleep less than seven hours a night face a higher likelihood of developing high blood pressure. Research also suggests that an irregular sleep schedule can increase this risk. Fortunately, improving sleep habits might help lower this risk.

Regarding safety, no specific data indicates negative effects from naturally improving sleep. Since the study focuses on natural methods to enhance sleep, it is generally considered safe. It promotes better sleep habits without medications or invasive methods, allowing participants to feel confident that this approach is likely well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep Enhancement protocol for high blood pressure because it offers a non-pharmacological approach, unlike the typical reliance on medications like ACE inhibitors and beta-blockers. This method focuses on improving sleep quality, which can have a significant impact on blood pressure regulation. By addressing underlying sleep issues, it could potentially reduce the need for medication and its associated side effects. Meanwhile, the Health Education component serves as a placebo comparator, highlighting the specific impact of sleep improvement on hypertension.

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

Research has shown that more sleep can help lower blood pressure in individuals with high blood pressure who struggle with sleep. One study found that adding about 35 minutes of sleep each night for six weeks reduced the top blood pressure number by 14 points and the bottom number by 8 points. This trial will compare Sleep Enhancement, which aims to improve sleep duration and quality, with Health Education as a comparator. Evidence suggests that improving sleep could be a promising method for those dealing with both sleep and blood pressure issues. ^{1 4 6 7 8}

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

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]

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]

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]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4209022/

Sleep to lower elevated blood pressure: study protocol for a ... In this trial, we will determine the efficacy of an online sleep intervention in improving blood pressure, in participants with hypertension and poor sleep ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8730491/

Sleep Duration and Hypertension: Epidemiological Evidence ... During this trial, increasing sleep duration by approximately 35 minutes per night over 6 weeks decreased systolic and diastolic blood pressure by 14 and 8 mm ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836172

Morning vs Bedtime Dosing and Nocturnal Blood Pressure ... Our study found that bedtime dosing can better control of nocturnal BP and improve the circadian rhythm compared with morning dosing, without ...

4. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.120.14479

Effect of Sleep Disturbances on Blood Pressure These data demonstrate that repeated exposure to shortened sleep reduces BP dipping, despite intermittent catch-up sleep. Whether frequent ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S277248752500025X

Association of sleep duration with hypertension in young ... This meta-analysis revealed an association between sleep duration (short [<7 h] and long [≥9 h]) and the development of hypertension in young and middle-aged ...

6. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.122.20513

Sleep Irregularity Is Associated With Hypertension This study examined associations between irregularity in sleep duration and timing with hypertension in a large, global sample over multiple months.

7. heart.org heart.org/en/news/2023/03/28/irregular-sleep-schedule-linked-to-high-blood-pressure

Irregular sleep schedule linked to high blood pressure People with irregular sleep patterns may face substantially higher odds of high blood pressure than those who stick to a schedule.

8. acc.org acc.org/About-ACC/Press-Releases/2024/03/26/18/40/getting-too-little-sleep-linked-to-high-blood-pressure

Getting Too Little Sleep Linked to High Blood Pressure The study found that sleeping less than seven hours was associated with a 7% increased risk of developing high blood pressure, which spiked to ...