Regularized Sleep Schedule for Sleep

Phase-Based Estimates
1
Effectiveness
1
Safety
Oregon Health and Science University, Portland, OR
+1 More
Regularized Sleep Schedule - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Sleep

Study Summary

This study is evaluating whether sleeping less or more than 8 hours per night may have negative impacts on cardiovascular health, physical activity, and sleep quality.

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Eligible Conditions

  • Sleep
  • Cardiovascular Risk

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Regularized Sleep Schedule will improve 20 primary outcomes in patients with Sleep. Measurement will happen over the course of 2 weeks.

2 weeks
24-hour BP measurement
Blood Cholesterol
Blood cortisol
Blood fasting glucose
Blood pressure
Body Mass Index (BMI)
C-reactive protein
Cardiovascular Risk
Content of caloric intake
Coronary Atherosclerotic Burden
Heart rate
Interleukins
P-selectin
Physical Activity
Plasminogen activator inhibitor-1
Sleep duration
Sleep efficiency
Timing of caloric intake
Total Mood Disturbance
Vascular Endothelial Function

Trial Safety

Safety Estimate

1 of 3

Trial Design

3 Treatment Groups

No Control Group
Short Sleepers

This trial requires 112 total participants across 3 different treatment groups

This trial involves 3 different treatments. Regularized Sleep Schedule is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Short Sleepers
Behavioral
Reported nightly sleep time of ≤6 hours
Long Sleepers
Behavioral
Reported nightly sleep time of ≥9 hours
Average Duration Sleepers
Behavioral
Reported nightly sleep time of 7-8 hours

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2 weeks for reporting.

Who is running the study

Principal Investigator
S. T.
Prof. Saurabh Thosar, Assistant Professor
Oregon Health and Science University

Closest Location

Oregon Health and Science University - Portland, OR

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
No weapons This is a safe space This is a safe space for people who do not use prescription or non-prescription medications or drugs of abuse and who do not carry weapons. show original
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. show original
This text is about the average age ranges for men and women show original
Lean and overweight (BMI 18.5-40 kg/m2)
No person shall be employed by the district if they have any acute, chronic, or debilitating medical conditions. show original
I have never smoked tobacco, and I have never smoked marijuana show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is cardiovascular risk?

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We found that risk factors for CVD are not only present in, but predictive of, CVD. A number of factors related to both risk and prevention should be considered with these patients, such as lifestyle modification, optimal diet and control of blood pressure.

Unverified Answer

What causes cardiovascular risk?

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There are numerous factors that could contribute to higher CVD risk, but there seems to be little or no difference in CV risk between men and women. Diabetes and CVD risk factors, such as high blood pressure, high blood cholesterol and BMI, are positively associated with higher CVD risk in women.

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What are the signs of cardiovascular risk?

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The common cardiovascular risk factors of hypertension, obesity and tobacco and drink habits are highly important to diagnose. On the other hand, patients may be at a higher risk if they have a family history.

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What are common treatments for cardiovascular risk?

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The most frequent diagnoses and treatments for the cardiovascular risk condition were hypertension treatment, aspirin use, anti-smoker counseling, screening for dyslipidaemia, blood pressure counseling, and regular physical activity.

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How many people get cardiovascular risk a year in the United States?

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This is the first study to provide national estimates of cardiovascular risk in all adults in the U.S., measured via FRS, CVD, and diabetes risk scores, and has found significant variation by racial and ethnic group. This has an important implication for both clinical practice and public policy.

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Can cardiovascular risk be cured?

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Atherosclerosis may be managed (i) by the use of preventive treatments for the patient to halt the onset of cardiovascular events; (ii) by the use of vascular interventions to prevent future cardiovascular events; and (iii) by the use of pharmacologic medications to keep arterial blood pressure, blood lipids, or blood glucose in desired ranges.

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Who should consider clinical trials for cardiovascular risk?

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Clinicians must not underestimate their responsibility when making clinical decisions for patients presenting with a CVD risk profile. Even when patients are eligible for clinical trials, there appears to be a need for more information to assess the relevance of any individual risk factor in both the population as a whole and in individual patients before participation in a clinical trial. The clinical relevance of some common cardiovascular risk factors should be evaluated in prospective study population samples of patients with or without CVD. This is particularly relevant at this time when the relative risks of CVD are debated between statins and blood pressure reduction.

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Does regularized sleep schedule improve quality of life for those with cardiovascular risk?

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The present study demonstrated, for the first time, a significant association between a night sleep schedule and HRQOL among those with cardiovascular risks. However, there is no significant interaction between sleep wake schedule and HRQOL, so sleep schedule-based intervention could be helpful for those who have a difficulty in sleep at work and a busy lifestyle in a healthy lifestyle.

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What is the average age someone gets cardiovascular risk?

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The national median overall age at cardiovascular risk was 73 years. However, this varies according to ethnicity. White men and women had significantly lower ages at cardiovascular risk when compared to other racial/ethnic groups. Moreover, when stratified by age, there were racial/ethnic differences when using the FRS calculator, and more stringent definitions of cardiovascular risk are needed for ethnic minorities.

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How serious can cardiovascular risk be?

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Although common risk factors for coronary heart disease and heart attack are well documented, many people, including those considered to be in good health, may not be advised to undergo screening for these common risk factors. The magnitude and consequences of cardiovascular risk need further discussion.

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What is the primary cause of cardiovascular risk?

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As cardiovascular risk is a common end-point in clinical research, physicians who see large number of patients are most likely to be most knowledgeable of cardiovascular risk. Data from a recent study reveal that cardiovascular risk is most commonly caused by hypertension or hyperlipidemia (66% and 24%) and is also most common after the age of 40 (61%), with a slight gender difference. These data suggest that most cardiac and vascular risk in clinical research populations comes from two well-recognized sources as a primary endpoint.

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Is regularized sleep schedule typically used in combination with any other treatments?

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The study demonstrates, for the first time, that a regularized sleep schedule is not a dominant factor in the use of adjunctive therapies. These data suggest that more studies are warranted to investigate whether adherence to an individualized exercise program in addition to a regular sleep schedule promotes positive clinical outcomes in individuals with chronic obstructive pulmonary disease.

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