Sleep Health Intervention for High Blood Pressure

Overseen By Nour Makarem, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Cardiovascular disease, Cancer, Severe psychiatric, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how improving sleep can help manage high blood pressure and other health factors in Hispanic/Latina/o/x adults. Participants will be divided into two groups: one will learn about heart health, while the other will also receive tips and coaching to improve sleep through the Multidimensional Sleep Health Promotion Intervention. The trial seeks individuals who speak English or Spanish, have high blood pressure, and struggle with sleep. As an unphased trial, this study offers a unique opportunity to contribute to valuable research that could enhance health outcomes for the community.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this sleep health intervention is safe for participants?

Research has shown that programs to improve sleep are generally easy for participants to handle. These programs avoid medication, often resulting in fewer side effects. Previous studies on non-drug sleep programs with healthy individuals found no major safety issues.

Examining sleep from various perspectives has demonstrated positive effects on overall health without significant negative impacts. While these programs help improve sleep, they are usually safe for most people.

Participants in similar trials often report better sleep and overall well-being, with no serious side effects. However, individual experiences can vary. Prospective participants should discuss any concerns with the trial team before joining. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multidimensional Sleep Health Promotion Intervention because it offers a fresh approach to tackling high blood pressure by focusing on sleep health. Unlike standard treatments that primarily involve medication or lifestyle changes targeting diet and exercise, this intervention emphasizes improving sleep quality through personalized feedback, behavioral coaching, and environmental adjustments like managing light and noise. This holistic method not only aims to enhance sleep but also indirectly supports cardiovascular health, potentially providing a comprehensive and sustainable way to manage high blood pressure.

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

This trial will compare a Multidimensional Sleep Health Promotion Intervention with standard care. Research has shown that better sleep can improve overall health, including lowering blood pressure. Studies have found that personalized feedback and behavior coaching, components of the intervention arm in this trial, help people sleep better. Improved sleep benefits heart health by reducing high blood pressure. A comprehensive approach to sleep health examines various factors like sleep environment and habits, which link to health benefits. Early findings suggest that focusing on these sleep factors positively affects blood pressure and other health indicators. ^{2 6 7 8 9}

Who Is on the Research Team?

Nour Makarem, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for Hispanic/Latina/o/x adults with high blood pressure. Participants should be interested in improving their sleep health to potentially better their heart health and lifestyle factors. Details on specific inclusion or exclusion criteria are not provided, but typically these would outline who can safely participate.

Inclusion Criteria

Systolic blood pressure greater than or equal to 120 mmHg

Presence of sub-optimal sleep health

I am between 30 and 65 years old.

Exclusion Criteria

Presence of severe psychiatric disorders

I am unable to understand or complete the study tasks.

Presence of optimal sleep health

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a multidimensional sleep health promotion intervention, including virtual sleep health education, personalized feedback, and behavioral coaching

24 weeks

Regular virtual sessions

Follow-up

Participants are monitored for changes in cardiometabolic health indicators and sleep health

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multidimensional Sleep Health Promotion Intervention

Trial Overview

The study tests a special program designed to help people sleep better and see if it improves blood pressure and other health markers related to diabetes and weight. Half the participants will get this new sleep improvement program, while the other half will receive standard heart health information.

How Is the Trial Designed?

Group I: Multidimensional Sleep Health Promotion Intervention Experimental Treatment 1 Intervention

Participants randomized to the intervention arm will receive: 1. A multi-component multidimensional sleep health promotion intervention that includes report back of sleep health profiles, S.M.A.R.T. goal setting, sleep health coaching, establishment of fixed sleep schedule, virtual sleep hygiene education, self-monitoring, personalized feedback and supportive accountability, and addressing light and noise in the sleep environment. 2. Cardiovascular health education materials based on the American Heart Association's Life's Essential 8 framework.

Group II: Standard of care Active Control 1 Intervention

Participants randomized to the control arm will receive standard American Heart Association Life's Essential 8 cardiovascular health education materials, providing guidance on healthy sleep duration only.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

In a study of 11,561 Chinese students aged 9-18, those who slept 8-9 hours had a significantly lower risk of high blood pressure (HBP) compared to those sleeping more than 10 hours, indicating that optimal sleep duration is crucial for cardiovascular health in children.

Sleep consistency, particularly bedtime regularity, was linked to HBP, with irregular bedtimes increasing the risk, while midday napping did not show a significant association with HBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between sleep characteristics and risk for high blood pressure among students aged 9-18: A cross-sectional study in China. Cui, L., Li, J., Lou, X., et al.[2023]

A sleep health program consisting of four weekly group sessions significantly improved both objective and self-reported sleep parameters among 63 members of the German Armed Forces, demonstrating its effectiveness as a workplace health promotion tool.

Participants in the treatment group experienced notable improvements in sleep quality metrics, including sleep efficiency and latency to persistent sleep, with moderate effects on daytime sleepiness, indicating the program's potential as a preventive measure for sleep issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Workplace-Based Sleep Health Program on Sleep in Members of the German Armed Forces. Sauter, C., Kowalski, JT., Stein, M., et al.[2020]

A 6-week technology-assisted sleep extension intervention significantly improved total sleep time and reduced both systolic and diastolic blood pressure in adults with prehypertension or stage 1 hypertension, indicating its potential efficacy in managing these conditions.

Participants found the intervention enjoyable and engaged well, completing 90% of coaching sessions, which suggests that such technology-assisted approaches could be feasible and well-received for improving sleep and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology Assisted Behavior Intervention to Extend Sleep Among Adults With Short Sleep Duration and Prehypertension/Stage 1 Hypertension: A Randomized Pilot Feasibility Study. Baron, KG., Duffecy, J., Richardson, D., et al.[2023]

In a 3-month pilot trial involving 29 older adults, an intervention using visualized sleep report feedback and health guidance significantly improved sleep latency, total sleep time, and sleep efficiency, indicating potential benefits for sleep quality.

The intervention led to a notable increase in total sleep time and improved sleep efficiency by the end of the study, suggesting that this approach could be effective in enhancing sleep among older adults, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of sleep report feedback using information and communication technology combined with health guidance on improving sleep indicators in community-dwelling older people: a pilot trial. Mo, W., Yamakawa, M., Takahashi, S., et al.[2023]

Sleep health disparities (SHDs) are prevalent among disadvantaged populations in the U.S. and are linked to various negative health outcomes and behaviors, indicating a significant public health concern.

To effectively address SHDs, researchers recommend integrating sleep health with existing health disparity frameworks and developing comprehensive interventions that consider multiple factors influencing sleep and health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A workshop report on the causes and consequences of sleep health disparities. Jackson, CL., Walker, JR., Brown, MK., et al.[2021]

A web-delivered sleep intervention significantly improved sleep quality and psychosocial health in 134 participants with mild sleep impairment, but it did not lead to significant reductions in blood pressure over 8 weeks.

The intervention group showed notable improvements in various sleep quality measures and mental health indicators, but the change in 24-hour ambulatory systolic blood pressure was similar to the control group, indicating that while sleep quality improved, it did not translate to immediate cardiovascular benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep to Lower Elevated Blood Pressure: A Randomized Controlled Trial (SLEPT). McGrath, ER., Espie, CA., Power, A., et al.[2018]

Short sleep duration (6-7 hours) and long sleep duration (over 8 hours) are both associated with an increased prevalence of hypertension, particularly in individuals under 45 and over 45 years old, respectively.

Habitual daytime napping appears to have a protective effect against hypertension, especially in individuals over 45 years old, and may reduce hypertension risk in those who sleep 7-8 hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of long-term sleep habits and hypertension: a cross-sectional study in Chinese adults. Zhao, H., Gui, W., Huang, H., et al.[2022]

In a study of 12,166 adults aged 30-79, poor sleep patterns, including short sleep duration, trouble sleeping, and diagnosed sleep disorders, were significantly associated with an increased risk of hypertension, with odds ratios indicating a strong correlation.

Specifically, individuals with poor sleep patterns had nearly double the odds (OR = 1.90) of developing hypertension compared to those with healthier sleep patterns, highlighting the importance of good sleep for cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship between Sleep and Hypertension: Findings from the NHANES (2007-2014). Li, C., Shang, S.[2021]

Sleep deficiency is a widespread issue among hospitalized patients, influenced by factors like existing health conditions and the hospital environment, which can negatively affect multiple organ systems.

To improve patient outcomes, it's crucial to enhance objective sleep measurement methods in hospitals and standardize study protocols to better assess the effectiveness of sleep promotion strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding Insult to Injury: Sleep Deficiency in Hospitalized Patients. Mansour, W., Knauert, M.[2023]

Involving stakeholders such as young adults, parents, and healthcare providers in the development of sleep promotion programs for adolescents is essential for creating effective and acceptable interventions, as highlighted by feedback from 9 focus groups with 49 participants.

Strategies to improve adolescent sleep should focus on enhancing internal motivation, personalizing content, and encouraging parents to model good sleep behaviors, which can help sustain behavior change and make programs more feasible and scalable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing adolescent sleep interventions with stakeholder input. Levenson, JC., Ford, HA., Reyes, ZMD., et al.[2022]

The SLeep Education for Elders Program (SLEEP) showed sustained improvements in sleep quality, duration, insomnia symptoms, and sleep hygiene behaviors six months after the program ended, based on surveys from 19 participants.

These findings indicate that community-delivered sleep education interventions can effectively address uncomplicated sleep issues and provide lasting benefits beyond the program duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SLeep Education for Everyone Program (SLEEP) Results in Sustained Improvements in Sleep Outcomes at Six Months. Haggerty, D., Contreras, DA., Carter, A., et al.[2023]

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