Varied Sleep Patterns for Cardiometabolic Health

Recruiting in Palo Alto (17 mi)

Overseen by Marie-Pierre St-Onge, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Columbia University

Must not be taking: Beta-blockers, Anti-coagulants, Anti-platelets

Disqualifiers: Sleep disorders, Psychiatric disorders, Diabetes, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test the impact of repeated intermittent short sleep, with short sleep maintained 5 days per week followed by 2 days of prolonged sleep, compared to daily adequate sleep, on energy balance and cardiometabolic risk. A secondary goal of this research is to determine if maintaining a constant midpoint of sleep while undergoing intermittent short sleep, leads to better outcomes than intermittent short sleep with a 2-hour delay in sleep midpoint. The aims of this research will be tested in the context of a 3-group, parallel-arm, outpatient intervention of 4 weeks in duration, in young-to-middle-aged adults (aged 18-49 years).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking beta-blockers, anti-coagulants, or anti-platelets.

What data supports the effectiveness of the treatment Varied Sleep Patterns for Cardiometabolic Health?

Research shows that irregular sleep patterns, like social jetlag, are linked to higher risks of obesity, diabetes, and heart issues. Regular and adequate sleep can help reduce these risks by improving metabolic health. ^{1 2 3 4 5}

Is varied sleep pattern treatment safe for humans?

Research on varied sleep patterns, like social jetlag, suggests it may be linked to higher body weight and cardiometabolic risks, such as obesity and poor nutrient intake. However, these studies focus on associations rather than direct safety evaluations, so more research is needed to fully understand the safety of these sleep patterns. ^{1 6 7 8 9}

How does the treatment of Intermittent Short Sleep (ISS) and Social Jetlag (SJL) differ from other treatments for cardiometabolic health?

This treatment is unique because it focuses on managing sleep patterns, specifically the timing and duration of sleep, to address cardiometabolic health. Unlike traditional treatments that might focus on medication or diet, this approach targets the circadian rhythm (the body's internal clock) and its impact on metabolism, which is a novel way to address issues like obesity and diabetes. ^{1 2 6 10 11}

Research Team

Marie-Pierre St-Onge, PhD

Principal Investigator

Columbia University

Eligibility Criteria

This trial is for adults aged 18-49 with a BMI of 20-29.9 who usually sleep 7-9 hours without aids or naps. It's not for those who've recently changed weight, are in weight loss programs, have had bariatric surgery, smoke, have sleep disorders, take certain blood medications, have psychiatric conditions including eating disorders and seasonal affective disorder, are pregnant or breastfeeding, have high blood pressure on beta-blockers or diabetes.

Inclusion Criteria

I usually sleep 7-9 hours a night without needing sleeping pills or naps.

Your body mass index (BMI) is between 20 and 29.9.

I am between 18 and 49 years old.

Exclusion Criteria

You frequently travel to different time zones, or work non-traditional hours such as night shifts.

I am currently taking blood thinners.

I have recently changed my weight, joined a weight loss program, or had weight loss surgery.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants undergo a 3-group, parallel-arm, outpatient intervention to test the impact of sleep patterns on cardiometabolic health

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• Intermittent Short Sleep (ISS) (Behavioral Intervention)
• Social Jetlag (SJL) (Behavioral Intervention)
• Sustained Adequate Sleep (SAS) (Behavioral Intervention)

Trial Overview The study compares the effects of intermittent short sleep (5 days of less sleep followed by 2 days of more) to consistent adequate nightly sleep on heart health and metabolism over an eight-week period. It also examines if keeping a constant midpoint of sleep during short nights affects outcomes differently than shifting it later.

Participant Groups

Group I: ISS_SJL Experimental Treatment 2 Interventions

Intermittent short sleep with short jetlag (SJL) 5 nights of 5.5 hours time in bed 2 nights of 9.5 hours time in bed with constant bedtimes and delayed wake times

Group II: ISS_Alone Experimental Treatment 1 Intervention

Intermittent short sleep (ISS) 5 nights of 5.5 hours time in bed 2 nights of 9.5 hours time in bed with advanced bedtimes and delayed wake times

Group III: Stable Adequate Sleep (SAS) Active Control 1 Intervention

Participants will go to bed and wake up at the same time every night, maintaining adequate sleep duration.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Dr. Katrina Armstrong

Columbia University

Chief Executive Officer

MD from Johns Hopkins University, MS in Epidemiology from Harvard School of Public Health

Dr. Katrina Armstrong

Columbia University

Chief Medical Officer

MD from Harvard Medical School

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Aviva Abosch

University of Colorado, Denver

Chief Medical Officer since 2019

MD

Uday B. Kompella

University of Colorado, Denver

Chief Executive Officer since 2015

PhD in Pharmaceutical Sciences

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

Findings from Research

In a study of 1,208 Hispanic youth aged 8-16, social jetlag (the difference in sleep timing between weekdays and weekends) was linked to healthier behaviors, including more physical activity and a higher healthy eating index, as well as lower odds of being overweight.

Conversely, shorter sleep duration was associated with less physical activity but did not show a significant relationship with other cardiometabolic outcomes, suggesting that sleep timing may be more critical for health than total sleep duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of sleep duration and social jetlag with cardiometabolic risk factors in the study of Latino youth. Johnson, DA., Reid, M., Vu, TT., et al.[2021]

In a study of 145 healthy participants, those with 2 or more hours of social jetlag exhibited higher cortisol levels, less sleep during the week, and increased resting heart rates compared to those with 1 hour or less of social jetlag.

The findings suggest that social jetlag is linked to negative endocrine, behavioral, and cardiovascular risk factors, potentially increasing the risk for metabolic diseases and mental health issues like diabetes and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is social jetlag associated with an adverse endocrine, behavioral, and cardiovascular risk profile? Rutters, F., Lemmens, SG., Adam, TC., et al.[2014]

In a study of 792 patients with non-communicable chronic diseases, social jetlag was found to be positively associated with higher fasting glucose levels, indicating a potential link to metabolic complications.

Patients experiencing social jetlag of more than 1 hour had double the odds of being overweight and 1.8 times the odds of being metabolically unhealthy obese, suggesting that disrupted circadian rhythms may increase the risk of obesity and related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social jetlag and metabolic control in non-communicable chronic diseases: a study addressing different obesity statuses. Mota, MC., Silva, CM., Balieiro, LCT., et al.[2019]

In a study of 1164 Japanese employees, greater social jetlag (the difference in sleep times between weekdays and weekends) was linked to a higher likelihood of developing metabolic syndrome (MetS), with an odds ratio of 1.92 for those experiencing 2 or more hours of social jetlag.

Specifically, individuals with greater social jetlag were more likely to have high waist circumference, with an odds ratio of 2.26 for those with 2 or more hours of jetlag, indicating a potential risk factor for obesity-related health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of social jetlag with metabolic syndrome among Japanese working population: the Furukawa Nutrition and Health Study. Islam, Z., Akter, S., Kochi, T., et al.[2022]

In a study of 599 young adults, those with significant social jetlag (SJL) of 2 hours or more were more likely to experience greater weight gain over a 2-year period.

Reducing social jetlag may help improve weight status in young adults, highlighting the importance of consistent sleep patterns for maintaining a healthy weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persistent, High Levels of Social Jetlag Predict Poor Weight Outcomes in a Weight Gain Prevention Study for Young adults. Hayes, JF., Schumacher, LM., Lanoye, A., et al.[2023]

In a study of 5015 UK adults, short sleep duration (less than 7 hours) was linked to higher intakes of unhealthy sugars and carbohydrates, as well as lower fiber intake, indicating that sleep patterns can influence dietary choices.

While both short sleep and social jetlag were associated with poor dietary habits, only short sleep was connected to increased body fat, suggesting that insufficient sleep may have a more direct impact on body composition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short sleep and social jetlag are associated with higher intakes of non-milk extrinsic sugars, and social jetlag is associated with lower fibre intakes in those with adequate sleep duration: a cross-sectional analysis from the National Diet and Nutrition Survey Rolling Programme (Years 1-9). Al Khatib, H., Dikariyanto, V., Bermingham, KM., et al.[2023]

A large-scale epidemiological study indicates that social jetlag, the mismatch between our biological and social clocks, is linked to increased body mass index (BMI), suggesting it may contribute to obesity.

The findings highlight the importance of aligning biological and social schedules, which could be beneficial in managing obesity, especially in discussions about Daylight Saving Time and work or school hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social jetlag and obesity. Roenneberg, T., Allebrandt, KV., Merrow, M., et al.[2022]

Chronic stress and poor sleep quality among university professors are linked to increased cardiometabolic risks, with 41.2% of participants reporting poor sleep despite working 40 hours a week.

Social jetlag (SJL) was found to correlate with higher blood glucose levels, indicating that disruptions in circadian rhythms can negatively impact metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiometabolic risk factors and social jetlag in university professors. Galeno, DML., Peixoto, HJA., Carneiro, BTS., et al.[2023]

Individuals with an evening chronotype are associated with higher body mass index (BMI), elevated fasting blood glucose, increased total cholesterol, and lower levels of high-density lipoprotein cholesterol (HDL-C) compared to those with a morning chronotype, based on a meta-analysis of 27 studies.

Participants experiencing larger social jetlag (SJL) also exhibited larger waist circumference, indicating a link between SJL and obesity-related metabolic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between metabolic parameters and evening chronotype and social jetlag in non-shift workers: A meta-analysis. Zhang, R., Cai, X., Lin, C., et al.[2022]

References

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

Associations of sleep duration and social jetlag with cardiometabolic risk factors in the study of Latino youth. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Irregular sleep and cardiometabolic risk: Clinical evidence and mechanisms. [2023]

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

Is social jetlag associated with an adverse endocrine, behavioral, and cardiovascular risk profile? [2014]

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

Social jetlag and metabolic control in non-communicable chronic diseases: a study addressing different obesity statuses. [2019]

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

Associations of chronotype and sleep patterns with metabolic syndrome in the Hispanic community health study/study of Latinos. [2023]

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

Association of social jetlag with metabolic syndrome among Japanese working population: the Furukawa Nutrition and Health Study. [2022]

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

Persistent, High Levels of Social Jetlag Predict Poor Weight Outcomes in a Weight Gain Prevention Study for Young adults. [2023]

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

Short sleep and social jetlag are associated with higher intakes of non-milk extrinsic sugars, and social jetlag is associated with lower fibre intakes in those with adequate sleep duration: a cross-sectional analysis from the National Diet and Nutrition Survey Rolling Programme (Years 1-9). [2023]

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

Social jetlag and obesity. [2022]

10. Brazil pubmed.ncbi.nlm.nih.gov

Cardiometabolic risk factors and social jetlag in university professors. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

The association between metabolic parameters and evening chronotype and social jetlag in non-shift workers: A meta-analysis. [2022]