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

Trial Summary

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 6 7}

How 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. ^{1 2 8 9 10}

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.

Research Team

Andrew W McHill, PhD

Principal Investigator

Oregon Health and Science University

Eligibility 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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 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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Association of self-reported sleep disturbances with ideal cardiovascular health in Brazilian adults: A cross-sectional population-based study. [2022]

2. England 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Association of healthy sleep pattern with risk of recurrent cardiovascular events among patients with coronary heart disease. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The Lifestyle-Related Cardiovascular Risk Is Modified by Sleep Patterns. [2023]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Disruption of Circadian Rhythms and Sleep on Critical Illness and the Impact on Cardiovascular Events. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The Association Between Race, Ethnicity and Sleep Quality and Duration: A National Health Interview Survey Study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Daytime sleep accelerates cardiovascular recovery after psychological stress. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Validation of the Sleep Regularity Index in Older Adults and Associations with Cardiometabolic Risk. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Sleep and vascular disorders. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Sleep Irregularity and Subclinical Markers of Cardiovascular Disease: The Multi-Ethnic Study of Atherosclerosis. [2023]