Sleep Health for Heart and Metabolic Health

Not currently recruiting at 1 trial location

Overseen By Research Project Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Cardiovascular disease, Cancer, Pregnancy, others

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

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to improve heart and metabolic health by adding a sleep health program, Sleep2BWell, to an existing lifestyle program focused on diet and physical activity. The goal is to determine if better sleep can reduce high blood pressure and improve overall health habits. English or Spanish speakers who are at least 20 years old and have high blood pressure (at least 120 mmHg) might be suitable candidates. Participants will use a Fitbit to track their sleep and receive tools like a sleep mask and air purifier to enhance sleep conditions. The trial takes place in community centers and faith-based organizations in underserved NYC neighborhoods. As an unphased trial, this study offers a unique opportunity to explore innovative ways to enhance health through improved sleep.

Will I have to stop taking my current medications?

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

What prior data suggests that the Sleep2BWell intervention is safe for improving cardiometabolic health?

Research shows that the Sleep2BWell program is generally safe, although specific safety data from studies is not yet available. Sleep2BWell is a lifestyle program that includes sleep education, coaching, and environmental changes, such as using a sleep mask or air purifier. These components are non-invasive, meaning they don't involve surgery or medical procedures, and they aim to improve sleep health, suggesting a low risk of side effects.

The program is based on the BWell4Life initiative, which promotes healthy eating and exercise. Programs like these are usually well-tolerated. Since Sleep2BWell builds on a program with similar features, it is reasonable to expect participants will find it just as safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep2BWell program because it combines traditional lifestyle changes with a comprehensive approach to improving sleep health. Unlike current treatments that often focus solely on diet and exercise, Sleep2BWell adds elements like sleep education, stress management, and environmental modifications to address structural sleep barriers. Participants get tools such as a Fitbit, sleep mask, and air purifier, along with coaching to optimize sleep routines. This holistic approach could lead to better sleep quality, which in turn may enhance heart and metabolic health more effectively than conventional methods.

What evidence suggests that this trial's treatments could be effective for improving cardiometabolic health?

Research has shown that better sleep can greatly improve heart health and how the body handles sugar. Studies have found that good sleep, combined with a healthy diet and regular exercise, helps lower blood pressure and maintain stable blood sugar levels. In this trial, the Sleep2BWell Intervention Arm educates participants about sleep and promotes healthy lifestyle changes to enhance these benefits. Early results suggest that addressing sleep issues, such as noise and light, leads to better health. Participants in this arm will use devices like Fitbits and address sleep disturbances, potentially strengthening these improvements. This method is designed to be easy to use and effective in everyday life. ^{1 2 3 6 7}

Who Is on the Research Team?

Nour Makarem, PhD, FAHA

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

The Sleep2BWell trial is for individuals interested in improving their sleep, diet, physical activity, and reducing high blood pressure. Participants will be from underserved NYC neighborhoods and involved with faith-based organizations or community centers. They should be willing to engage in a 6-week program involving education sessions, self-monitoring with Fitbit devices, and addressing environmental factors affecting sleep.

Inclusion Criteria

I am 20 years old or older.

Having at minimum SBP in the elevated or hypertension category (SBP ≥120 mmHg)

Exclusion Criteria

I have a history of heart disease or cancer.

No known medical conditions that would prevent them from safely participating in the trial (e.g., neurological degenerative disease such as Parkinson's, severe psychiatric disorders, substance use disorder)

Pregnant or desire to become pregnant during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

BWell4Life Program

Participants engage in a 4-week community health promotion program focused on lifestyle change through diet and physical activity.

4 weeks

Weekly educational sessions

Sleep2BWell Intervention

Participants receive an enhanced 6-week intervention including sleep health education, group coaching, and addressing environmental barriers to healthy sleep.

6 weeks

Two sleep health education and group coaching sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 10 weeks and 24 weeks.

24 weeks

Assessments at 10 weeks and 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep2BWell

Trial Overview This study tests if adding sleep health components to the BWell4Life program can better improve cardiometabolic health (CMH). It compares two groups: one follows the standard BWell4Life plan focusing on diet and exercise; the other adds sessions on sleep health plus tools like Fitbits to monitor progress.

How Is the Trial Designed?

Group I: Sleep2BWell Intervention Arm Experimental Treatment 3 Interventions

Sleep2BWell is a 6-week program, which consists of the 4-wk BWell4Life program enhanced with two sleep health education and group coaching sessions and addressing structural barriers to healthy sleep in NYC (light, noise, and indoor air pollution). The sleep health education sessions will incorporate didactic content, engaging animated videos, group coaching, and an interactive Q\&A period. These sessions will incorporate techniques to establish regular bed and wake times, learn wind-down and wake-up routines, cope with stress through muscle relaxation and mindfulness techniques, and optimize the sleep environment. Participants will self-monitor using a Fitbit and will receive additional instruction on how to maximize health benefits of self-monitoring. They will also receive a sleep mask, ear plugs, a blue light blocker, and an indoor air purifier to address barriers to healthy sleep in the sleep environment.

Group II: BWell4Life Control Arm Active Control 2 Interventions

BWell4Life is a 4-week community health promotion program focused on lifestyle change through consumption of a healthy diet and being physically active through weekly educational sessions, setting specific, measurable, attainable, realistic, and timely (S.M.A.R.T.) goals for health behavior modification, and didactic content based on the American Heart Association (AHA) Life's Essential 8 framework. The two diet sessions include an overview of nutrition basics, examples of healthy dietary patterns and cooking methods to increase consumption of plant-based foods and healthy proteins and reduce intakes of red and processed meats, sugary foods, and sugar-sweetened beverages. The two physical activity sessions provide an overview of the physical activity guidelines and include 30-60 minutes of exercise. These sessions also address achieving and maintaining a healthy body weight. Participants will receive a Fitbit for self-monitoring and collecting sleep health and physical activity data.

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+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

Patients with various cardiovascular diseases often experience poor sleep quality and duration, which are linked to worse cardiovascular outcomes, indicating that sleep issues should be addressed in treatment plans.

There is a complex, bidirectional relationship between sleep and cardiovascular diseases, suggesting that improving sleep could be a valuable target for treatment, although current studies show mixed results regarding survival benefits from sleep interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep - the yet underappreciated player in cardiovascular diseases: A clinical review from the German Cardiac Society Working Group on Sleep Disordered Breathing. Spiesshoefer, J., Linz, D., Skobel, E., et al.[2023]

In a study of 155,203 participants, it was found that only 69.5% reported getting at least 7 hours of sleep, and a significant 73.9% reported poor sleep quality, highlighting a widespread issue with sleep among different ethnic groups.

Filipinos and Other Asians were less likely to achieve adequate sleep compared to Whites and Chinese, while all Asian groups reported better sleep quality than Whites, indicating notable disparities in sleep patterns across these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association Between Race, Ethnicity and Sleep Quality and Duration: A National Health Interview Survey Study. Inam, M., Kianoush, S., Sheikh, S., et al.[2023]

In a study of 21,193 individuals with coronary heart disease followed for an average of 11.1 years, maintaining a healthy sleep pattern was linked to a 12-22% lower risk of heart failure and recurrent cardiovascular events.

Participants with a higher healthy sleep score (4) had a significantly reduced risk of recurrent cardiovascular events (HR 0.86), heart failure (HR 0.71), and stroke (HR 0.72), suggesting that good sleep habits can help prevent further cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of healthy sleep pattern with risk of recurrent cardiovascular events among patients with coronary heart disease. Liu, S., Wang, Y., Lu, Q., et al.[2023]

In a study of 36,480 Brazilian adults, those without sleep disturbances had significantly better cardiovascular health, as indicated by higher Life's Simple 7 (LS7) scores, compared to those experiencing sleep issues.

The severity of sleep disturbances was directly linked to lower cardiovascular health scores, with individuals reporting disturbances almost every day having the lowest scores, suggesting that improving sleep quality could be important for enhancing cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of self-reported sleep disturbances with ideal cardiovascular health in Brazilian adults: A cross-sectional population-based study. Velasquez-Melendez, G., Andrade, FCD., Moreira, AD., et al.[2022]

In a study of 2,162 participants, significant associations were found between sleep structure (like total sleep time and sleep efficiency) and metabolic syndrome, hypertension, diabetes, and obesity, suggesting that sleep quality may influence these health conditions.

However, after adjusting for various factors such as age, sex, and sleep disorders, these associations diminished, indicating that normal variations in sleep may have little impact on metabolic syndrome and related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective sleep structure and cardiovascular risk factors in the general population: the HypnoLaus Study. Haba-Rubio, J., Marques-Vidal, P., Andries, D., et al.[2022]

Epidemiological studies indicate that shorter sleep duration is linked to increased risks of metabolic disorders like obesity, diabetes, and hypertension, suggesting a mechanistic relationship between sleep and metabolism.

Sleep deprivation negatively affects hormones related to appetite and insulin sensitivity, which can lead to insulin resistance and hypertension, highlighting the importance of improving sleep quality and duration as potential preventive measures for these metabolic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidemiological evidence for the links between sleep, circadian rhythms and metabolism. Gangwisch, JE.[2022]

In a study of 121 participants aged 40-70 with multiple cardio-metabolic risk factors, those who underwent a health and lifestyle modification program showed a greater reduction in systolic blood pressure compared to the usual care group after 24 months.

Improvements in sleep quality, specifically increased sleep efficiency and total sleep time, were independently linked to lower blood pressure and improved cholesterol levels, suggesting that enhancing sleep could be an effective strategy for reducing cardio-metabolic risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved sleep efficiency is associated with reduced cardio-metabolic risk: Findings from the MODERN trial. Yiallourou, SR., Carrington, MJ.[2021]

A systematic review of 10 studies found that subjective sleep complaints, such as trouble falling asleep, are associated with an increased risk of coronary heart disease (CHD), with risk ratios ranging from 1.47 to 3.90 after adjusting for other factors.

The findings suggest that insomnia may be linked to heart problems through mechanisms like poor health, depression, stress, and reduced slow-wave sleep, indicating a need for further investigation into these connections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia and heart disease: a review of epidemiologic studies. Schwartz, S., McDowell Anderson, W., Cole, SR., et al.[2022]

Sleep significantly influences cardiovascular function, affecting the autonomic nervous system and systemic hemodynamics, which can lead to serious events like cardiac arrhythmias and sudden death.

There is a causal link between sleep disorders (like sleep apnea and shift work) and cardiovascular diseases such as hypertension and heart failure, highlighting the need for better understanding and treatment strategies for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep and cardiovascular disease. Wolk, R., Gami, AS., Garcia-Touchard, A., et al.[2022]

Sleep impairment is not only a consequence of cardiovascular diseases but can also increase the risk of conditions like hypertension and stroke, highlighting the importance of monitoring heart rate abnormalities during sleep for early detection of cardiovascular issues.

Melatonin may play a crucial role in regulating cardiovascular function and sleep patterns, as disruptions in the circadian cycle and chronic sleep deficits are linked to increased sympathetic nervous system activity and a higher risk of obesity and cardiovascular diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep and vascular disorders. Plante, GE.[2015]

A multidimensional sleep health (MDSH) score, based on factors like sleep duration and regularity, was linked to significantly lower odds of cardiovascular disease (CVD) and type 2 diabetes among 4555 adults, indicating that better sleep health can improve cardiometabolic health.

Participants with ideal sleep health had 62% lower odds of hypertension and 73% lower odds of obesity compared to those with poor sleep health, highlighting the importance of comprehensive sleep assessments in understanding cardiovascular risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multidimensional Sleep Health Is Associated with Cardiovascular Disease Prevalence and Cardiometabolic Health in US Adults. Makarem, N., Alcantara, C., Musick, S., et al.[2023]

In a study of 103 participants aged 25-64, a stable sleep pattern and higher daytime activity were linked to better cardiometabolic health, including lower weight, waist circumference, and blood pressure.

Higher night activity was associated with poorer sleep quality and increased levels of inflammatory markers like CRP, suggesting that maintaining a regular sleep-wake rhythm is crucial for cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sleep-wake cycle regularity and cardiometabolic indicators]. Bochkarev, MV., Korostovtseva, LS., Tataraidze, AB., et al.[2021]

A study of 277 Chinese participants identified 64 plasma metabolites linked to sleep timing, revealing that later sleep times are associated with higher levels of metabolites involved in amino acid and lipid metabolism.

The findings suggest that sleep timing, rather than sleep duration, may significantly impact cardiometabolic health by influencing various metabolic pathways, indicating potential areas for health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Habitual Sleep and human plasma metabolomics. Xiao, Q., Derkach, A., Moore, SC., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/tMNPJ0EPsU6g3aolWXoDKw/project-details/10892512

Project Details We hypothesize that SLEEP2BWELL will enhance the effectiveness of BWELL4LIFE leading to greater improvements in CMH, including reduced blood pressure (primary ...

2. ctv.veeva.com ctv.veeva.com/study/the-sleep2bwell-cluster-randomized-trial

The Sleep2BWell Trial - ClinicalTrials.Veeva The investigators hypothesize that Sleep2BWell will enhance the effectiveness of BWell4Life leading to greater improvements in CMH, including ...

3. withpower.com withpower.com/trial/sleep-health-for-heart-and-metabolic-health-c49ce

Sleep Health for Heart and Metabolic Health The investigators hypothesize that Sleep2BWell will enhance the effectiveness of BWell4Life leading to greater improvements in CMH, including reduced blood ...

4. sleep2bwell.org sleep2bwell.org/en/our-purpose

Our Purpose - Home | Sleep2BWell Our study aims to discover if making our sleep better, along with eating healthier and being more active, can improve our heart health.

5. cms.vibrenthealth.com cms.vibrenthealth.com/en/group/896

Home | Sleep2BWell - Research Team - Vibrent Health To improve sleep and diet quality as well as promote a physically active lifestyle in populations at greatest risk for developing heart disease and cancer. Our ...

6. reporter.nih.gov reporter.nih.gov/search/14E8C00D468AC0D67598B8961CAA4A01A2FFCEB861BF/project-details/10928218

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

7. cms.vibrenthealth.com cms.vibrenthealth.com/en/group/896/privacy

Privacy | Sleep2BWell - Research Team - Vibrent Health We collect and use Personal Information for internal and service-related purposes. This may involve sharing information with third parties who ...