Regularized Sleep Schedule for Cardiovascular Risk

(Goldilocks Trial)

Overseen By Nicole Chaudhary, MPH

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

112 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a cross-sectional study with an optional intervention that will examine how extreme sleep durations relate to cardiovascular health, physical activity, and sleep quality by studying three groups of participants: short sleepers (≤ 6 hrs), long sleepers (≥ 9 hrs), and average duration sleepers (7-8 hrs). The optional intervention asks participants to maintain an 8-hour per night regular sleep schedule for one week.

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 data supports the effectiveness of the treatment Regularized Sleep Schedule for reducing cardiovascular risk?

Research shows that irregular sleep patterns are linked to higher risks of heart disease and related conditions. Regularizing sleep schedules may help lower these risks by improving sleep quality and reducing stress, which are important for heart health. ^{1 2 3 4 5}

Is a regularized sleep schedule safe for humans?

Research suggests that maintaining a regular sleep schedule is generally safe and may help reduce cardiovascular risks associated with irregular sleep patterns, such as those seen in shift workers. Irregular sleep can lead to increased cardiovascular risk, but a consistent sleep schedule may help mitigate these risks. ^{6 7 8 9 10}

How does a regularized sleep schedule treatment differ from other treatments for cardiovascular risk?

A regularized sleep schedule treatment is unique because it focuses on aligning sleep patterns to reduce cardiovascular risk, unlike traditional treatments that may focus on medication or lifestyle changes like diet and exercise. This approach addresses the impact of sleep duration and circadian rhythm alignment on heart health, which is not typically the primary focus of standard cardiovascular treatments. ^{7 10 11 12 13}

Research Team

Saurabh S Thosar, PhD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. 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]

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

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

5. England pubmed.ncbi.nlm.nih.gov

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

6. Germany pubmed.ncbi.nlm.nih.gov

Circadian rhythm, sleep pattern, and metabolic consequences: an overview on cardiovascular risk factors. [2015]

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

Social jetlag, a novel predictor for high cardiovascular risk in blue-collar workers following permanent atypical work schedules. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

The impact of the circadian timing system on cardiovascular and metabolic function. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Shift working and cardiovascular health. [2023]

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

Correlations between sleep patterns and cardiovascular diseases in a Chinese middle-aged population. [2022]

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

Sleep duration and risk of ischemic stroke in postmenopausal women. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Biological pathways underlying the association between habitual long-sleep and elevated cardiovascular risk in adults. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Sleep and cardiovascular disease. [2022]