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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to test the efficacy of a behavioral sleep extension intervention on sleep duration, cardio-metabolic disease risk factors, and health behaviors among adults with elevated blood pressure/hypertension and short sleep duration.

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 data supports the effectiveness of the treatment Sleep Extension for High Blood Pressure?

Research shows that patient education can significantly improve blood pressure control, with one study noting a 28% increase in patients achieving controlled blood pressure when educational interventions were used. This suggests that the educational components of the Sleep Extension treatment could be effective in managing high blood pressure. ^{1 2 3 4 5}

Is sleep extension for high blood pressure safe for humans?

Health education interventions, including patient education and telehealth education, have been shown to be safe for managing high blood pressure, with no adverse psychological effects reported and improved health outcomes. ^{1 6 7 8 9}

How does the Sleep Extension for High Blood Pressure treatment differ from other treatments for high blood pressure?

This treatment is unique because it focuses on extending sleep duration and providing health education through telehealth, which is different from traditional medication-based approaches. It aims to improve blood pressure management by enhancing lifestyle habits and increasing patient awareness, rather than relying solely on drugs. ^{6 9 10 11 12}

Eligibility Criteria

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.

I am between 18 and 65 years old.

Able to read/write in English

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Arterial hypertension: lessons from patient education. [2019]

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

Health education for hypertensive patients. [2016]

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

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

4. 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]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. Malaysia pubmed.ncbi.nlm.nih.gov

The effect of health education intervention through mobile phone on hypertension patients : A systematic review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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

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

Five-year blood pressure control and mortality following health education for hypertensive patients. [2019]

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

The National High Blood Pressure Education Program: measuring progress and assessing its impact. [2004]

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

Increasing Awareness of Hypertensive Patients About Their Blood Pressure Readings During Clinic Visits in a Tertiary Hospital in Riyadh. [2023]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Education of patients with arterial hypertension. State of art and prospects]. [2009]

12. France pubmed.ncbi.nlm.nih.gov

[The "health booklet for hypertensive patients"]. [2007]