Sleep Regularity for Cardiovascular Health
(DISCO Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Oregon Health and Science University
Disqualifiers: Cardiovascular diseases, Hypertension, Diabetes, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this study is to identify the effects of sleep regularity on cardiovascular regulatory mechanisms. The investigators are hoping to discover if improving the regularity of sleep timing will improve metabolic and vascular health markers. The protocol is a 12-week prospective cohort study that includes both field and in-laboratory data collection in ostensibly healthy male and female adults, aged 18-40years.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the study involves ostensibly healthy individuals without certain health conditions, it's possible that some medications might not be allowed. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the treatment Sleep Regularity Group for cardiovascular health?
Research shows that poor sleep quality and irregular sleep patterns are linked to worse heart health, while healthy sleep patterns can reduce the risk of heart problems. Improving sleep regularity may help improve cardiovascular health by addressing these issues.
12345Is the Sleep Regularity treatment safe for humans?
The research suggests that poor sleep quality and inadequate sleep duration are linked to negative cardiovascular outcomes, but there is no specific safety data on the Sleep Regularity treatment itself. Some studies have shown benefits in selected patients with cardiovascular diseases, but more research is needed to confirm safety.
12367How does the Sleep Regularity Group treatment differ from other treatments for cardiovascular health?
The Sleep Regularity Group treatment is unique because it focuses on improving the regularity of sleep patterns, which has been linked to reducing the risk of cardiovascular diseases. Unlike other treatments that may target specific symptoms or conditions, this approach aims to address sleep irregularity as a modifiable factor to improve overall cardiovascular health.
128910Eligibility Criteria
This trial is for healthy men and women aged 18-40 who are interested in how sleep patterns affect heart health. Participants should have a regular daily routine but may have varying sleep schedules. The study excludes those with known cardiovascular or metabolic disorders, shift workers, pregnant individuals, and anyone on medication affecting sleep or circadian rhythms.Inclusion Criteria
I am generally healthy.
Exclusion Criteria
I have pre-diabetes or diabetes.
I have a gastrointestinal condition.
Chronobiologic and sleep disorders
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Outpatient Biobehavioral Weeks
Actigraphy data collected across 2-weeks to assess habitual sleep patterns and calculate a sleep regularity index (SRI)
2 weeks
Continuous monitoring with actigraphy device
Biobehavioral Laboratory Visit
Participants visit the laboratory for two in-laboratory visits in dim-light settings, involving an evening stay to measure circadian markers, body composition, and vascular function
1 week
2 visits (in-person)
Ambulatory Monitoring
Biobehavioral data collection at Weeks 1-2, Weeks 6-7, and Weeks 11-12 for intervention group; Weeks 11-12 for control group. Includes actigraphy, sleep logs, ambulatory blood pressure, and glucose monitoring
12 weeks
Continuous monitoring with actigraphy and glucose monitor
Follow-up
Participants are monitored for changes in cardiovascular and metabolic markers post-intervention
4 weeks
Participant Groups
The study is examining the impact of consistent sleep times on heart and blood vessel health over a 12-week period. It involves tracking participants' normal life routines as well as specific assessments conducted in a lab setting to measure changes in their cardiometabolic health.
2Treatment groups
Experimental Treatment
Active Control
Group I: Sleep Regularity GroupExperimental Treatment1 Intervention
Individuals in the lowest SRI tertile will begin the 12-week intervention to improve sleep regularity. Participants will be instructed to maintain a consistent sleep onset time (±30 min self-selected sleep time).
Group II: Control GroupActive Control1 Intervention
All other participants will be instructed to maintain their habitual sleep patterns.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Oregon Health & Science UniversityPortland, OR
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Who Is Running the Clinical Trial?
Oregon Health and Science UniversityLead Sponsor
Medical Research Foundation, OregonCollaborator
References
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.
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.
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).
The Lifestyle-Related Cardiovascular Risk Is Modified by Sleep Patterns. [2023]To prospectively assess whether sleep patterns modified lifestyle-associated cardiovascular disease (CVD) risk.
Disruption of Circadian Rhythms and Sleep on Critical Illness and the Impact on Cardiovascular Events. [2019]The cardiovascular system exhibits significant daily rhythms in physiologic processes (heart rate, blood pressure, cardiac contractility and function), and molecular gene and protein expression. An increasing number of clinical and experimental studies demonstrate the circadian system is an important underlying mechanism that coordinates these rhythmic processes for the health of the cardiovascular system. However, what happens when rhythms are disturbed has been generally clinically unappreciated. Here we describe the profound adverse impact of disturbed circadian rhythms and sleep on the cardiovascular system, including recovery from myocardial infarction in acute care settings, shift work and heart disease, sleep disorders including obstructive sleep apnea, and cardiovascular pathophysiology associated with disturbed nocturnal blood pressure profiles. We also discuss therapeutic applications of circadian rhythms for the cardiovascular system. Cardiovascular disease is a leading cause of death worldwide, and applying circadian biology to cardiology (and indeed medicine in general) provides a new translational approach to benefit patients clinically.
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.
Daytime sleep accelerates cardiovascular recovery after psychological stress. [2021]Sleep restriction and poor sleep quality is linked with cardiovascular morbidity.
Validation of the Sleep Regularity Index in Older Adults and Associations with Cardiometabolic Risk. [2022]Sleep disturbances, including insufficient sleep duration and circadian misalignment, confer risk for cardiometabolic disease. Less is known about the association between the regularity of sleep/wake schedules and cardiometabolic risk. This study evaluated the external validity of a new metric, the Sleep Regularity Index (SRI), among older adults (n = 1978; mean age 68.7 ± 9.2), as well as relationships between the SRI and cardiometabolic risk using data from the Multi-Ethnic Study of Atherosclerosis (MESA). Results indicated that sleep irregularity was associated with delayed sleep timing, increased daytime sleep and sleepiness, and reduced light exposure, but was independent of sleep duration. Greater sleep irregularity was also correlated with 10-year risk of cardiovascular disease and greater obesity, hypertension, fasting glucose, hemoglobin A1C, and diabetes status. Finally, greater sleep irregularity was associated with increased perceived stress and depression, psychiatric factors integrally tied to cardiometabolic disease. These results suggest that the SRI is a useful measure of sleep regularity in older adults. Additionally, sleep irregularity may represent a target for early identification and prevention of cardiometabolic disease. Future studies may clarify the causal direction of these effects, mechanisms underlying links between sleep irregularity and cardiometabolic risk, and the utility of sleep interventions in reducing cardiometabolic 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.
Sleep Irregularity and Subclinical Markers of Cardiovascular Disease: The Multi-Ethnic Study of Atherosclerosis. [2023]Background Sleep irregularity has been linked to incident cardiovascular disease. Less is known about associations of sleep regularity with atherosclerosis. We examined cross-sectional associations of actigraphy-assessed sleep duration and sleep timing regularity with subclinical atherosclerosis in the community-based MESA (Multi-Ethnic Study of Atherosclerosis). Methods and Results MESA Sleep Ancillary Study participants (N=2032; mean age, 68.6±9.2 years; 37.9% White) completed 7-day wrist actigraphy. Participants underwent assessments of coronary artery calcium, carotid plaque presence, carotid intima-media thickness, and the ankle-brachial index. Sleep regularity was quantified by the 7-day with-in person SD of sleep duration and sleep onset timing. Relative risk regression models were used to calculate prevalence ratios and 95% CIs. Models are adjusted for demographics, cardiovascular disease risk factors, and other objectively assessed sleep characteristics including obstructive sleep apnea, sleep duration, and sleep fragmentation. After adjustment, compared with participants with more regular sleep durations (SD ≤60 minutes), participants with greater sleep duration irregularity (SD >120 minutes) were more likely to have high coronary artery calcium burden (>300; prevalence ratio, 1.33 [95% CI, 1.03-1.71]) and abnormal ankle-brachial index (90 minutes) were more likely to have high coronary artery calcium burden (prevalence ratio, 1.39 [95% CI, 1.07-1.82]). Associations persisted after adjustment for cardiovascular disease risk factors and average sleep duration, obstructive sleep apnea, and sleep fragmentation. Conclusions Sleep irregularity, particularly sleep duration irregularity, was associated with several measures of subclinical atherosclerosis. Sleep regularity may be a modifiable target for reducing atherosclerosis risk. Future investigation into cardiovascular risk reduction interventions targeting sleep irregularity may be warranted.