Sleep Regularity for Cardiovascular Health

(DISCO Trial)

Overseen By Andrew W McHill, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Cardiovascular diseases, Hypertension, Diabetes, others

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

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if maintaining a regular sleep schedule can improve heart and metabolic health. Participants will either follow a set sleep routine (Sleep Regularity Group) or maintain their usual sleep habits for 12 weeks. The trial seeks generally healthy adults without heart issues, diabetes, or sleep disorders, and who have not recently worked night shifts. Participants must also be non-smokers and free from alcohol or drug dependency. As an unphased trial, this study provides participants the chance to contribute to valuable research that could enhance understanding of sleep's impact on health.

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 prior data suggests that this protocol is safe for cardiovascular health?

Research has shown that a regular sleep schedule is linked to better heart health. Studies have found that people with irregular sleep patterns face a higher risk of heart problems and other health issues. Inconsistent sleep is associated with a greater risk of heart disease and even early death.

The treatment in this clinical trial aims to improve sleep regularity. Participants will go to bed at the same time each night, within about 30 minutes of their chosen bedtime. This trial involves no drugs or invasive procedures, only a change in sleep habits.

Since this trial focuses on adjusting sleep habits rather than taking medication, it is generally considered safe. No reports of serious side effects have emerged from simply changing sleep schedules. The goal is to determine if making sleep more regular can improve heart and metabolic health.

In summary, regularizing sleep schedules is not only safe but could also benefit heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep Regularity intervention for improving cardiovascular health because it focuses on enhancing the consistency of sleep patterns rather than introducing new medications or invasive procedures. Unlike traditional treatments that might involve drugs for managing cardiovascular risk factors, this method encourages individuals to maintain a consistent sleep schedule, which could offer a natural and sustainable way to improve heart health. By targeting sleep regularity, this approach aims to harness the body's natural rhythms to potentially reduce cardiovascular issues, offering a promising, low-risk alternative to current treatment options.

What evidence suggests that improving sleep regularity might be effective for cardiovascular health?

This trial will compare the effects of sleep regularity on cardiovascular health. Research has shown that a regular sleep schedule can greatly improve heart health. Participants in the Sleep Regularity Group will undergo a 12-week intervention to enhance sleep regularity. Studies have found that irregular sleep patterns are linked to a higher risk of heart problems and even a shorter lifespan. By maintaining a consistent sleep routine, participants can lower the chances of heart-related issues, such as conditions that increase heart disease risk and early artery damage. Keeping a regular sleep schedule may also aid in recovering from heart conditions. Overall, maintaining a steady sleep routine supports better heart and overall health. ^{1 2 6 7 8}

Who Is on the Research Team?

Andrew W McHill, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Regularity Group

Trial Overview 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.

How Is the Trial Designed?

Group I: Sleep Regularity Group Experimental Treatment 1 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 Group Active Control 1 Intervention

All other participants will be instructed to maintain their habitual sleep patterns.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Medical Research Foundation, Oregon

Collaborator

Trials

14

Recruited

1,100+

Published Research Related to This Trial

In a study of 1,978 older adults, greater sleep irregularity, measured by the Sleep Regularity Index (SRI), was linked to increased risks of cardiovascular disease and various metabolic issues like obesity and diabetes, independent of total sleep duration.

The findings suggest that sleep irregularity could be a significant factor in identifying and preventing cardiometabolic diseases, highlighting the need for further research into the mechanisms behind this relationship and potential sleep interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Sleep Regularity Index in Older Adults and Associations with Cardiometabolic Risk. Lunsford-Avery, JR., Engelhard, MM., Navar, AM., et al.[2022]

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]

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]

In a study of 2032 participants from the MESA Sleep Ancillary Study, greater irregularity in sleep duration was linked to a higher risk of subclinical atherosclerosis, indicated by increased coronary artery calcium and abnormal ankle-brachial index.

Participants with irregular sleep timing also showed a higher likelihood of having significant coronary artery calcium, suggesting that maintaining regular sleep patterns could be an important factor in reducing cardiovascular disease risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Irregularity and Subclinical Markers of Cardiovascular Disease: The Multi-Ethnic Study of Atherosclerosis. Full, KM., Huang, T., Shah, NA., et al.[2023]

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 393,690 participants over nearly 9 years, poor sleep patterns were found to significantly increase the risk of cardiovascular disease (CVD) and myocardial infarction (MI) when combined with an unfavorable lifestyle, with risks rising by 25% and 29% respectively.

Conversely, participants with healthy sleep patterns experienced lower increases in CVD and MI risk (18% and 17%) from the same unfavorable lifestyle, suggesting that good sleep can help mitigate some of the negative effects of poor lifestyle choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Lifestyle-Related Cardiovascular Risk Is Modified by Sleep Patterns. Song, Q., Wang, M., Zhou, T., et al.[2023]

In a study of 85 healthy young adults, those who took a 60-minute daytime nap showed significantly lower mean arterial pressure during recovery from stress compared to those who did not sleep.

These results suggest that daytime sleep can help improve cardiovascular recovery from psychological stress, indicating a potential benefit for individuals with poor nighttime sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daytime sleep accelerates cardiovascular recovery after psychological stress. Brindle, RC., Conklin, SM.[2021]

Disturbed circadian rhythms and sleep can have serious negative effects on cardiovascular health, impacting recovery from heart attacks and contributing to conditions like heart disease and sleep disorders.

Understanding and applying circadian biology in cardiology could lead to new therapeutic strategies that improve patient outcomes in cardiovascular disease, which is a major global health issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disruption of Circadian Rhythms and Sleep on Critical Illness and the Impact on Cardiovascular Events. Reitz, CJ., Martino, TA.[2019]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11145062/

The Emerging Importance of Sleep Regularity on ... Low sleep regularity was consistently associated with higher cardiovascular risk and elevated risk of all-cause mortality. Results on cognitive ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.033043

Sleep Patterns and Traditional Cardiovascular Health Metrics Enhanced CVH significantly reduced CVD risk, even in individuals with a poor sleep pattern. These results emphasize the importance of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666667724002939

A contemporary review of sleep and cardiovascular health Sleep regularity has emerged as a strong and independent risk factor for CVD-related mortality, cardiometabolic syndrome, and subclinical atherosclerosis. Less ...

4. news.ohsu.edu news.ohsu.edu/2025/08/21/regular-sleep-schedule-may-improve-recovery-from-heart-failure-study-finds

Regular sleep schedule may improve recovery from heart ... Regular sleep schedule may improve recovery from heart failure, study finds OHSU review suggests a consistent sleep schedule is especially ...

5. nature.com nature.com/articles/s41598-025-15828-6

The impact of sleep health on cardiovascular and all-cause ... Sleep patterns are important predictors of long-term health outcomes. We investigated the associations of sleep duration, sleep regularity, ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.124.011873

Device-Measured Sleep Characteristics, Daily Step Count, ... Sleep regularity and steps, and sleep duration and steps showed clear and graded associations with overall cardiometabolic health (Figure 1). We ...

7. sleephealthjournal.org sleephealthjournal.org/article/S2352-7218(23)00166-3/fulltext

The importance of sleep regularity: a consensus statement ... SRI independent of sleep duration. Greater sleep irregularity correlated with 10-y risk of cardiovascular disease, greater obesity, hypertension ...

8. academic.oup.com academic.oup.com/sleep/article/47/1/zsad253/7280269

Sleep regularity is a stronger predictor of mortality risk than ... Studies with longitudinal measures of sleep regularity have found associations between irregular sleep and adverse cardiometabolic outcomes [12, 14–17], ...