Regularized Sleep Schedule for Cardiovascular Risk

(Goldilocks Trial)

Overseen By Saurabh S Thosar, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Must not be taking: Prescription drugs, Non-prescription drugs

Disqualifiers: Chronic conditions, Psychiatric disorders, others

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

Compensation: Varies

Number of Visits: 2

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different sleep habits affect heart health, exercise, and overall sleep quality. Participants will be grouped by their usual sleep patterns: short sleepers (6 hours or less), long sleepers (9 hours or more), and average sleepers (7-8 hours). An optional part allows participants to try an 8-hour sleep schedule for a week, known as a Regularized Sleep Schedule. This study may suit individuals aged 25 to 65 who are generally healthy and do not smoke or take medications. As an unphased trial, it offers a unique opportunity to contribute to understanding the impact of sleep habits on health.

Do I need to stop taking my current medications to join the trial?

Yes, you must stop taking any prescription or non-prescription medications to participate in this trial.

What prior data suggests that a regularized sleep schedule is safe for cardiovascular health?

Research has shown that a regular sleep schedule is linked to better heart health. People who do not maintain a consistent sleep pattern face a higher risk of heart issues, such as heart attacks and strokes. Thus, a consistent sleep routine might help lower these risks.

There is no specific information about side effects or safety concerns with regularizing sleep schedules, as it is a natural lifestyle change rather than a medication or medical procedure. Generally, changing sleep habits is considered safe. Most people do not experience negative effects from going to bed and waking up at the same times daily. It is a simple and non-invasive way to potentially improve overall health and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how adjusting sleep schedules might impact cardiovascular risk. Unlike standard treatments that often involve medications or lifestyle changes like diet and exercise, this trial is focused on the simple act of regularizing sleep duration. By examining different sleep patterns—short, average, and long sleep durations—the trial aims to uncover how sleep consistency influences heart health. This could lead to a non-invasive and easily adoptable approach for reducing cardiovascular risk, offering a fresh perspective beyond traditional methods.

What evidence suggests that a regularized sleep schedule is effective for cardiovascular health?

This trial will evaluate the impact of a regularized sleep schedule on cardiovascular risk. Research has shown that a regular sleep schedule can reduce the risk of heart problems. Studies have found that people who go to bed and wake up at the same time every day tend to have healthier hearts. In fact, a consistent sleep routine predicts heart health better than just the number of hours slept. People with irregular sleep patterns face a higher likelihood of serious heart issues, such as heart attacks and strokes. Following a regular sleep schedule might also aid recovery from heart conditions. Overall, maintaining a consistent sleep routine could be an easy way to improve heart health. Participants in this trial will be grouped based on their reported nightly sleep duration to assess the effects of sleep regularity on heart health. ^{2 3 4 5 6}

Who Is on the Research Team?

Saurabh S Thosar, PhD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for men and women aged 25-65 who don't smoke, have a BMI of 18.5-40, aren't on any medications or drugs, and don't have chronic health issues. It's not for those with recent shift work, extensive travel history, pregnant women, prisoners, or people with severe psychiatric conditions.

Inclusion Criteria

You do not smoke tobacco or marijuana currently.

My BMI is between 18.5 and 40.

People who fit all the criteria above, have a suitable medical history and health habits, and answer additional sleep and health questions may be eligible to participate.

Exclusion Criteria

I do not have any serious or long-term health conditions, except for slightly high blood pressure.

Persons with a history of regular night/or rotating shift work in the past year, or who have traveled more than three time zones during the one month prior to the study will be excluded.

You have a history of serious mental health issues or disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants measure sleep, physical activity, and blood pressure with at-home devices before coming in for one in-lab visit for vascular function and blood markers measurement

2 weeks

1 visit (in-person)

Optional Intervention

Participants maintain an 8-hour per night regular sleep schedule for one week while continuing at-home measures, followed by a second in-lab visit

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Regularized Sleep Schedule

Trial Overview The study looks at how different sleep durations affect heart health by observing three groups: short sleepers (≤6 hrs), long sleepers (≥9 hrs), and average sleepers (7-8 hrs). Participants can choose to follow an 8-hour nightly sleep schedule for one week as part of the intervention.

How Is the Trial Designed?

Group I: Short Sleepers Experimental Treatment 1 Intervention

Reported nightly sleep time of ≤6 hours

Group II: Long Sleepers Experimental Treatment 1 Intervention

Reported nightly sleep time of ≥9 hours

Group III: Average Duration Sleepers Experimental Treatment 1 Intervention

Reported nightly sleep time of 7-8 hours

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

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]

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]

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 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 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]

Citations

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

The Emerging Importance of Sleep Regularity on ... High sleep regularity was consistently associated with lower risks of cardiovascular disease and all-cause mortality and to a lesser extent ...

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

Sleep regularity is a stronger predictor of mortality risk than ... Emerging research demonstrates that sleep regularity, the day-to-day consistency of sleep–wake timing, can be a stronger predictor for some health outcomes than ...

3. 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 ...

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

The importance of sleep regularity: a consensus statement ... Association between actigraphy-based sleep duration variability and cardiovascular risk factors - results of a population-based study. Sleep Med ...

5. bmjgroup.com bmjgroup.com/irregular-sleep-wake-cycle-linked-to-heightened-risk-of-major-cardiovascular-events/

Irregular sleep-wake cycle linked to heightened risk of ... An irregular sleep-wake cycle is associated with a heightened risk of major cardiovascular events, such as heart attack and stroke, even for those who clock up ...

6. nih.gov nih.gov/news-events/nih-research-matters/irregular-sleep-patterns-may-raise-risk-heart-disease

Irregular sleep patterns may raise risk of heart disease Participants with the most irregular sleep schedules were nearly twice as likely to develop cardiovascular disease as those with more regular ...