Sleep Health for Heart and Metabolic Health
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen ByNour Makarem, PhD, FAHA
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Columbia University
Disqualifiers: Cardiovascular disease, Cancer, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Improving multiple domains of cardiometabolic health (CMH) through contextual behavioral interventions has the potential to substantially reduce persistent chronic disease disparities. Sleep is critical for preserving CMH and is amenable to intervention in real-world settings. Although sleep health, in conjunction with other lifestyle behaviors, can improve CMH through complementary or synergistic pathways, most existing lifestyle change programs focus solely on diet and physical activity. Sleep2BWell is a community-based cluster randomized trial aimed at evaluating the impact of incorporating a multidimensional sleep health intervention into the BWell4Life program, an ongoing 4-week program for promoting CMH through healthy diet and physical activity, delivered by peer health educators at faith-based organizations and community centers in underserved NYC neighborhoods. The enhanced 6-week intervention, Sleep2BWell, will include the following additional components: 1) two sleep health education and group coaching sessions, 2) self-monitoring and motivational enhancement using a Fitbit, and 3) addressing prevalent environmental barriers to healthy sleep in urban settings such as noise and light with a novel and timely extension to address indoor air pollution. A total of 14 community sites will be randomized into the intervention (Sleep2BWell) or control (BWell4Life) group, enrolling an average of 15 participants per site for an expected sample of 210. The investigators will collect objective measures of sleep and physical activity throughout the study, and assess diet and CMH outcomes at baseline, 10 weeks (primary endpoint), and 24 weeks (long-term follow-up to assess sustainability of the intervention's effect). The investigators hypothesize that Sleep2BWell will enhance the effectiveness of BWell4Life leading to greater improvements in CMH, including reduced blood pressure (primary outcome) improved health behaviors (sleep, diet, physical activity) and adiposity markers (secondary outcomes), as well as better glycemic control and inflammatory and allostatic load indicators (exploratory outcomes). To ensure the successful completion and future expansion of this work, this study will use mixed methods to understand implementation determinants and outcomes, guided by implementation science frameworks. This first-of-its-kind effectiveness-implementation study, addressing individual level behaviors and factors and upstream influences and leveraging key behavior change and community engagement strategies, will investigate the integration of sleep health into a multi-behavior lifestyle change intervention aimed at addressing CMH disparities in community settings. This innovative multilevel intervention will inform scalable sustainable community health approaches and public health policy to improve sleep health and CMH disparities through advancement in novel multilevel bundled behavioral interventions.
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 data supports the effectiveness of the treatment Sleep2BWell for heart and metabolic health?
Research shows that poor sleep quality and short sleep duration are linked to heart problems and metabolic issues like diabetes and obesity. Improving sleep could help reduce these risks, suggesting that treatments like Sleep2BWell might be beneficial for heart and metabolic health.
12345Is the Sleep2BWell treatment generally safe for humans?
The research articles do not provide specific safety data for the Sleep2BWell treatment, but they highlight the importance of good sleep for heart and metabolic health. Poor sleep is linked to higher risks of heart disease and other health issues, suggesting that improving sleep could be beneficial.
12678How does the Sleep2BWell treatment differ from other treatments for heart and metabolic health?
Sleep2BWell is unique because it focuses on improving sleep quality and efficiency as a way to reduce cardio-metabolic risk factors, such as high blood pressure and cholesterol levels, which is different from traditional treatments that may focus directly on medication or lifestyle changes without specifically targeting sleep.
910111213Eligibility Criteria
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)
I speak English or Spanish.
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
+1 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Sleep2BWell Intervention ArmExperimental Treatment3 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 ArmActive Control2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Weill Cornell MedicineNew York, NY
Columbia University Irving Medical Center, Mailman School of Public HealthNew York, NY
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
Weill Medical College of Cornell UniversityCollaborator
References
Sleep - the yet underappreciated player in cardiovascular diseases: A clinical review from the German Cardiac Society Working Group on Sleep Disordered Breathing. [2023]Patients with a wide variety of cardiovascular diseases, including arterial and pulmonary hypertension, arrhythmia, coronary artery disease and heart failure, are more likely to report impaired sleep with reduced sleep duration and quality, and also, sometimes, sleep interruptions because of paroxysmal nocturnal dyspnoea or arrhythmias. Overall, objective short sleep and bad sleep quality (non-restorative sleep) and subjective long sleep duration are clearly associated with major cardiovascular diseases and fatal cardiovascular outcomes. Sleep apnoea, either obstructive or central in origin, represents the most prevalent, but only one, of many sleep-related disorders in cardiovascular patients. However, observations suggest a bidirectional relationship between sleep and cardiovascular diseases that may go beyond what can be explained based on concomitant sleep-related disorders as confounding factors. This makes sleep itself a modifiable treatment target. Therefore, this article reviews the available literature on the association of sleep with cardiovascular diseases, and discusses potential pathophysiological mechanisms. In addition, important limitations of the current assessment, quantification and interpretation of sleep in patients with cardiovascular disease, along with a discussion of suitable study designs to address future research questions and clinical implications are highlighted. There are only a few randomised controlled interventional outcome trials in this field, and some of the largest studies have failed to demonstrate improved survival with treatment (with worse outcomes in some cases). In contrast, some recent pilot studies have shown a benefit of treatment in selected patients with underlying cardiovascular diseases.
The Association Between Race, Ethnicity and Sleep Quality and Duration: A National Health Interview Survey Study. [2023]Inadequate sleep duration and poor sleep quality are associated with adverse cardiovascular outcomes.
Association of healthy sleep pattern with risk of recurrent cardiovascular events among patients with coronary heart disease. [2023]To examine the association of a healthy sleep pattern with the risk of recurrent cardiovascular events among patients with coronary heart disease (CHD).
Association of self-reported sleep disturbances with ideal cardiovascular health in Brazilian adults: A cross-sectional population-based study. [2022]To examine the association between sleep disturbances and cardiovascular health in Brazilian adults.
Objective sleep structure and cardiovascular risk factors in the general population: the HypnoLaus Study. [2022]To evaluate the association between objective sleep measures and metabolic syndrome (MS), hypertension, diabetes, and obesity.
Insomnia and heart disease: a review of epidemiologic studies. [2022]Since the discovery and successful treatment of sleep apnea, researchers seem to believe that the association between sleep disturbance and coronary heart disease (CHD) has been explained. To determine whether subjective nighttime sleep complaints (trouble sleeping, trouble falling asleep, trouble staying asleep), exclusive of apnea, predicted myocardial infarction and other coronary events, a MEDLINE search was conducted for articles published between January 1976 through August 1997. Ten studies with an explicit measure of association between an insomniac complaint and CHD were identified. Reported risk ratios for various sleep complaints and CHD events ranged from 1.0 for waking too early and CHD death in an elderly North Carolina community to 8.0 for the highest versus lowest quintile of a sleep scale in Finnish men. Higher quality studies showed risk ratios of 1.47-3.90 between trouble falling asleep and coronary events after adjusting for age and various coronary risk factors (combined effect=1.7, p
Sleep and cardiovascular disease. [2022]Sleep is an important modulator of cardiovascular function, both in physiological conditions and in disease states. In individuals without a primary sleep disorder, sleep may exert significant effects on the autonomic nervous system, systemic hemodynamics, cardiac function, endothelial function, and coagulation. Some of these influences can be directly linked to specific modulatory effects of sleep stages per se; others result from the natural circadian rhythm of various physiological processes. There is a temporal association between physiological sleep and occurrence of vascular events, cardiac arrhythmias, and sudden death. Epidemiological and pathophysiological studies also indicate that there may be a causal link between primary sleep abnormalities (sleep curtailment, shift work, and sleep-disordered breathing) and cardiovascular and metabolic disease, such as hypertension, atherosclerosis, stroke, heart failure, cardiac arrhythmias, sudden death, obesity, and the metabolic syndrome. Finally, sleep disturbances may occur as a result of several medical conditions (including obesity, chronic heart failure, and menopause) and may therefore contribute to cardiovascular morbidity associated with these conditions. Further understanding of specific pathophysiological pathways linking sleep disorders to cardiovascular disease is important for developing therapeutic strategies and may have important implications for cardiovascular chronotherapeutics.
Multidimensional Sleep Health Is Associated with Cardiovascular Disease Prevalence and Cardiometabolic Health in US Adults. [2023]Individual sleep dimensions have been linked to cardiovascular disease (CVD) risk and cardiometabolic health (CMH), but sleep health is multifaceted. We investigated associations of a multidimensional sleep health (MDSH) score, enabling the assessment of sleep health gradients, with CVD and CMH. Participants were 4555 adults aged ≥20 years from the 2017-2018 National Health and Nutrition Examination Survey. A MDSH score, capturing poor, moderate, and ideal sleep was computed from self-reported sleep duration, sleep regularity, difficulty falling asleep, symptoms of sleep disorders, and daytime sleepiness. Survey-weighted multivariable linear and logistic models examined associations of MDSH with CVD and CMH. Ideal and moderate vs. poor MDSH were related to lower odds of hypertension (62% and 41%), obesity (73% and 56%), and central adiposity (68% and 55%), respectively; a statistically significant linear trend was observed across gradients of MDSH (p-trend < 0.001). Ideal vs. moderate/poor MDSH was associated with 32% and 40% lower odds of prevalent CVD and type 2 diabetes, respectively. More favorable MDSH was associated with lower blood pressure, BMI, waist circumference, and fasting glucose. In sex-stratified analyses, ideal vs. moderate/poor MDSH was associated with lower CVD odds and blood pressure in women only. The MDSH framework may be more than just the sum of its parts and could better capture information regarding CVD risk.
Sleep and vascular disorders. [2015]It is not surprising that cardiovascular diseases such as congestive heart failure and coronary insufficiency can give rise to varying degrees of sleep impairment; it is less readily appreciated that certain physiologic events occurring during sleep-as well as long-term unsatisfactory sleep-may cause or increase the risk of cardiovascular conditions such as hypertension, atherosclerosis, stroke, and cardiac arrythmias. Heart rate abnormalities during sleep in normotensive subjects predict later cardiovascular disease, and their early identification alerts the physician to undertake preventive measures. Maneuvers, such as induction of hypoxia, can elicit abnormal blood pressure responses during sleep, and such responses have been used to identify impending cardiovascular problems that could become therapeutic targets. The spontaneously hypertensive rat has been used to examine the effect of sympathetic nervous system (SNS) activity on the heart under a variety of experimental conditions, including quiet and paradoxical sleep. The results have disclosed significant differences between the responses of spontaneously hypertensive rats and normal rats to SNS stimulation. Exploration of other pathophysiologic pathways affected by exposure to light and dark, including those responsive to the cyclic production of melatonin, will improve our understanding of the effect of disruptions of the circadian cycle on cardiovascular function. There is growing evidence that melatonin can influence important processes such as fluid, nitrogen, and acid-base balance. Human subjects whose nocturnal arterial blood pressure fails to show the "normal" decrement during sleep ("nondippers") are also prone to sleep poorly, exhibit increased SNS activity during sleep, and have an increased risk of total and cardiovascular disease mortality. Chronic sleep deficit is now known to be a risk factor for obesity and may contribute to the visceral form of obesity that underlies the metabolic syndrome. The rising prevalence of obstructive sleep apnea and central sleep apnea is linked to the modern-day epidemic of obesity. Obstructive sleep apnea is associated with an enhanced risk of having a new stroke or a transient ischemic attack.
Habitual Sleep and human plasma metabolomics. [2022]Sleep plays an important role in cardiometabolic health. The sleep-wake cycle is partially driven by the endogenous circadian clock, which governs a range of metabolic pathways. The association between sleep and cardiometabolic health may be mediated by alterations of the human metabolome.
Epidemiological evidence for the links between sleep, circadian rhythms and metabolism. [2022]Epidemiological data reveal parallel trends of decreasing sleep duration and increases in metabolic disorders such as obesity, diabetes and hypertension. There is growing evidence that these trends are mechanistically related. The seasonal expression of the thrifty genotype provides a conceptual framework to connect circadian and circannual rhythms, sleep and metabolism. Experimental studies have shown sleep deprivation to decrease leptin, increase ghrelin, increase appetite, compromise insulin sensitivity and raise blood pressure. Habitually short sleep durations could lead to insulin resistance by increasing sympathetic nervous system activity, raising evening cortisol levels and decreasing cerebral glucose utilization that over time could compromise beta-cell function and lead to diabetes. Prolonged short sleep durations could lead to hypertension through raised 24-h blood pressure and increased salt retention resulting in structural adaptations and the entrainment of the cardiovascular system to operate at an elevated pressure equilibrium. Cross-sectional and longitudinal epidemiological studies have shown associations between short sleep duration and obesity, diabetes and hypertension. If metabolic changes resulting from sleep restriction function to increase body weight, insulin resistance and blood pressure then interventions designed to increase the amount and improve the quality of sleep could serve as treatments and as primary preventative measures for metabolic disorders.
[Sleep-wake cycle regularity and cardiometabolic indicators]. [2021]To evaluate the association between sleep-wake rhythm and cardiometabolic parameters.
Improved sleep efficiency is associated with reduced cardio-metabolic risk: Findings from the MODERN trial. [2021]Poor sleep increases cardio-metabolic risk, but limited information on the impact of sleep for the improvement of cardio-metabolic health exists. This analysis examined the impact of sleep on a health and lifestyle modification programme to reduce cardio-metabolic disease risk factors. Secondary analysis of the MODERN randomised controlled trial to reduce cardio-metabolic risk was undertaken at baseline and 24-month follow-up. Participants aged 40-70 years (n = 121) with three or more cardio-metabolic risk factors were randomised to a health and lifestyle modification intervention (n = 59) or usual care (n = 62), and underwent 7 day/night actigraphy to assess total sleep time, sleep efficiency (%), number of awakenings/night and physical activity levels. Blood pressure, blood lipid and glycaemic levels, anthropometric and diet measures were collected. The mean age was 59 ± 7 years and 37% were male. Baseline sleep measures were not different between groups. At the 24-month follow-up, both groups showed improvements in cardio-metabolic risk factors, albeit the change in blood pressure was greater in the intervention compared with the usual care group (systolic blood pressure: -11 versus -4 mmHg, p = .014). There were no differences between groups for diet, physical activity or sleep parameters. An increase in sleep efficiency was independently associated with lower systolic blood pressure (β = -2.117, p = .002) and higher high-density lipoprotein levels (β = 0.040, p = .033); an increase in total sleep time was associated with lower low-density lipoprotein levels (β = -0.003, p = .038) at 24 months. Overall, improvement in sleep quality over time was beneficial to reduce blood pressure and lipid levels. These findings highlight sleep as a potential target to reduce cardio-metabolic risk.