Sleep Extension for High Blood Pressure

(STITCH Trial)

Overseen By Sofia Vallejo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: Antihypertensives

Must not be taking: Hypnotics, Stimulants

Disqualifiers: Sleep apnea, Resistant hypertension, Psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether longer sleep can lower high blood pressure and improve heart health. Participants will either receive assistance to extend their sleep using tools like a Fitbit and coaching or receive general health education (also known as patient education or telehealth education). It is ideal for adults with high blood pressure who sleep less than 7 hours a night and use a smartphone. As an unphased trial, this study provides a unique opportunity to explore innovative methods to enhance heart health through improved sleep.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does allow participants who are on a stable dose of antihypertensive medications for more than 8 weeks.

What prior data suggests that this sleep extension intervention is safe for adults with high blood pressure?

Research shows that extending sleep time is generally well-tolerated by participants. Studies have found that this method, which involves sleeping more each night, usually doesn't cause negative side effects. Instead, it aims to improve sleep duration and help lower high blood pressure.

Participants in past studies on sleep extension have not reported significant negative effects. The main goal is to increase sleep, which can lead to better overall health. This is especially important for people with high blood pressure, as insufficient sleep is linked to a higher risk of hypertension and heart disease. The process usually includes using tools like a Fitbit and receiving advice from coaches, which have been safe and helpful for participants.

Since this approach doesn't involve medication or surgery, the risks are minimal. It focuses on making lifestyle changes in a safe and manageable way. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores non-pharmaceutical ways to manage high blood pressure through sleep extension and health education. Unlike standard treatments that often rely on medication like ACE inhibitors or beta-blockers, this approach focuses on behavioral changes. The sleep extension intervention is unique because it combines technology, like fitbits, with personalized coaching to encourage longer sleep duration. Meanwhile, the health education component aims to empower participants with knowledge and support to make healthier lifestyle choices. This trial could open new doors for managing high blood pressure by emphasizing lifestyle modifications rather than medication.

What evidence suggests that this sleep extension intervention is effective for high blood pressure?

Research has shown that getting more sleep can help lower blood pressure. One study found that people who slept longer had significantly lower blood pressure in the morning. Another study demonstrated that sleeping more increased total sleep time and lowered blood pressure throughout the day. In this trial, participants in the sleep extension group will receive interventions to increase sleep duration, potentially offering an easy way to control high blood pressure. This method focuses on improving sleep quality, which can benefit heart health. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-65 with high blood pressure or hypertension, sleeping less than 7 hours a night, and using a smartphone can join. They must be stable on blood pressure meds if taking any, not have severe depression or serious illnesses like cancer, avoid heavy alcohol use, and not work overnight shifts more than once a month.

Inclusion Criteria

My average blood pressure is between 115-145/75-90 mmHg, and I've been on a stable dose of blood pressure medication for over 8 weeks.

Able to read/write in English

You typically sleep less than 7 hours and spend less than 8 hours in bed, as measured by a special device.

Exclusion Criteria

Pregnancy/desire to become pregnant during the study period

You have a serious sleep disorder, such as obstructive sleep apnea, restless legs syndrome, or severe insomnia.

I have a history of cognitive or neurological disorders like dementia, Parkinson's, or Multiple Sclerosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a behavioral sleep extension intervention with weekly coaching calls and educational materials for 8 weeks

8 weeks

8 weekly coaching calls

Extended Treatment

Participants continue to receive educational materials and monthly emails from the coach for additional support

3-6 months

Monthly emails

Follow-up

Participants are monitored for cardiometabolic risk factors and health behaviors

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Health education
• Sleep extension intervention

Trial Overview

The trial is testing whether teaching people to sleep longer can improve their heart health and reduce risks for diseases related to high blood pressure. Participants will either receive sleep extension coaching or general health education.

How Is the Trial Designed?

Group I: Health education Experimental Treatment 1 Intervention

Participants in the health education group will receive 8 weekly health education emails and telephone calls to confirm their receipt and clarify any concepts from the materials. In months 3-6, they will receive monthly health education materials.

Group II: Behavioral sleep extension group Experimental Treatment 1 Intervention

Participants in the sleep extension group will receive a fitbit, weekly coaching calls and educational materials for 8 weeks. In months 3-6, they will receive educational materials and an email from the coach each month.

Health education is already approved in United States, European Union for the following indications:

Approved in United States as Health Education for:

• Chronic Pain Management
• Parkinson's Disease Management

Approved in European Union as Health Education for:

• Chronic Pain Management
• Parkinson's Disease Management
• General Health Promotion

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

A five-year study involving 400 urban poor hypertensive patients showed that health education interventions significantly improved compliance with treatment and blood pressure control, leading to better health outcomes.

The experimental group experienced a 57.3% reduction in all-cause mortality and a 53.2% reduction in hypertension-related mortality compared to the control group, highlighting the long-term benefits of these educational programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year blood pressure control and mortality following health education for hypertensive patients. Morisky, DE., Levine, DM., Green, LW., et al.[2019]

The National High Blood Pressure Education Program has successfully improved public knowledge about blood pressure and its related health issues over 15 years through targeted education efforts.

The program utilized various health-education strategies, including media development and community engagement, to effectively translate research findings into practical knowledge for patients and health professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The National High Blood Pressure Education Program: measuring progress and assessing its impact. Roccella, EJ., Horan, MJ.[2004]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11503376/

The Effect of Acute Sleep Extension on Blood Pressure Is ...

We observed morning blood pressure to be significantly reduced after one night of sleep extension in adults who had improved sleep efficiency. ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37817267/

a randomized controlled study of a behavioral sleep extension ...

The primary outcome is sleep duration at 8 weeks, and the secondary outcome is blood pressure at 8 weeks. Discussion: The results of this study will determine ...

3.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07658-6

a randomized controlled study of a behavioral sleep extension ...

The objective of this study is to test the effects of a behavioral sleep extension intervention on sleep duration, blood pressure, and other measures of ...

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jcsm.aasm.org

jcsm.aasm.org/doi/abs/10.5664/jcsm.8018

A Randomized Pilot Feasibility Study

Results at 6-week follow-up demonstrated greater improvement in the intervention group for total sleep time (P = .027), reductions in 24-hour systolic blood ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05062161

Sleep Duration and Blood Pressure During Sleep

The purpose of this study is to examine the impact that sleep duration has on blood pressure (BP) levels during sleep. The investigator will examine the ...

6.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2833842

Bedtime vs Morning Antihypertensive Medications in Frail ...

switching antihypertensives to bedtime failed to reduce a composite of death or major cardiovascular events that were primarily all-cause death.

7.

ahajournals.org

ahajournals.org/doi/10.1161/JAHA.124.035132

Short Sleep Duration and Hypertension: A Double Hit for ...

Cohort studies consistently show that short sleep duration is associated with an increased risk of hypertension, and cardiovascular disease, ...