Varied Sleep Patterns for Cardiometabolic Health

Overseen By Greiby Mercedes

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

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

Disqualifiers: Sleep disorders, Psychiatric disorders, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test how different sleep patterns affect energy and heart health. Participants will either follow a routine with varying sleep lengths across the week, known as Intermittent Short Sleep (ISS) and Social Jetlag (SJL), or maintain a steady sleep schedule, referred to as Sustained Adequate Sleep (SAS). The study will examine how these sleep patterns impact weight and heart-related risks. Ideal candidates are young to middle-aged adults who usually sleep 7-9 hours a night without sleep aids or naps. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research on sleep and health.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that insufficient sleep links to higher risks of health problems like heart disease and diabetes. Sleeping less than 6 hours a night can increase the risk of heart issues.

Regarding social jetlag (SJL), evidence is mixed. Some studies suggest it might lower good cholesterol and raise triglyceride levels, which are fats in the blood. However, other studies indicate it might associate with healthier habits and a lower risk of being overweight.

Overall, both lack of sleep and social jetlag pose some risks to heart and metabolic health. Considering these factors is important when thinking about joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how varying sleep patterns might improve cardiometabolic health in ways that traditional approaches haven't addressed. Unlike standard treatments that emphasize consistent sleep duration and timing, this trial examines the effects of intermittent short sleep (ISS) and social jetlag (SJL) on health. The ISS approach introduces variability by alternating between nights of restricted and extended sleep, while the SJL element explores the impact of shifting sleep schedules. These methods could reveal new insights into how sleep variability affects heart and metabolic health, potentially leading to more flexible and personalized sleep recommendations.

What evidence suggests that this trial's sleep patterns could be effective for cardiometabolic health?

Research has shown that getting too little sleep, like the short sleep patterns studied in the Intermittent Short Sleep (ISS) arms of this trial, links to health problems such as obesity and high blood pressure. Both insufficient and excessive sleep can harm heart and metabolic health.

The ISS_SJL arm also tests social jetlag, which is the mismatch between a person's sleep schedule and their body's natural rhythm. Evidence suggests it may increase the risk of diabetes and other metabolic issues, though this link is weaker than the one with short sleep. These findings explain why the study examines different sleep patterns, including the Stable Adequate Sleep (SAS) arm, to understand their effects on heart and metabolic health. ^{2 3 6 7 8}

Who Is on the Research Team?

Marie-Pierre St-Onge, PhD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

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]

Sleep regularity is crucial for overall health, and irregular sleep patterns are linked to an increased risk of cardiometabolic diseases such as coronary heart disease, hypertension, obesity, and diabetes, with the Sleep Regularity Index (SRI) showing a strong association with these conditions.

Different measures of sleep regularity, like the standard deviation of sleep duration and social jetlag, have varying impacts on health, indicating that specific metrics may be more relevant for certain populations, such as those with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irregular sleep and cardiometabolic risk: Clinical evidence and mechanisms. Zhang, C., Qin, G.[2023]

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 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 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]

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]

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]

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 2189 Hispanic/Latino adults, intermediate chronotype was linked to a higher risk of metabolic syndrome in those over 40, while a later chronotype was associated with a lower risk in those under 40, indicating that age influences how sleep patterns affect metabolic health.

Higher sleep efficiency was found to significantly reduce the odds of developing metabolic syndrome, suggesting that improving sleep quality may be beneficial for metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations of chronotype and sleep patterns with metabolic syndrome in the Hispanic community health study/study of Latinos. Maghsoudipour, M., Allison, MA., Patel, SR., et al.[2023]

Citations

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Sleep and Cardiometabolic Health: A Narrative Review of ... Habitual short sleep predicts higher incidence of metabolic syndrome and type 2 diabetes, while chronic insomnia is linked to 45% greater odds ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.124.011873

Device-Measured Sleep Characteristics, Daily Step Count, ... Sleep duration, which has been studied more extensively, appears to have a U-shaped association with adverse cardiometabolic health outcomes, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5567876/

Sleep Duration and Quality: Impact on Lifestyle Behaviors ... Sleep duration, mostly short sleep, and sleep disorders have emerged as being related to adverse cardiometabolic risk, including obesity, hypertension, type 2 ...

4. withpower.com withpower.com/trial/phase-metabolic-syndrome-5-2023-f4b45

Varied Sleep Patterns for Cardiometabolic Health 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 ...

5. mdpi.com mdpi.com/2072-6643/14/3/420

Sleep, Time-Restricted Eating, and Cardiometabolic Health This suggests a U-shape relationship between sleep and cardiometabolic health, with 7–9 h considered an optimum amount for favourable cardiometabolic outcomes [ ...

6. mdpi.com mdpi.com/2075-1729/15/1/60

The Effect of Sleep Disruption on Cardiometabolic Health Short sleep duration, typically defined as sleeping less than 6 h per night, has been consistently associated with an increased risk of cardiovascular mortality ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9806213/

Impact of objectively-measured sleep duration on ... In this review, we found a strong relationship between objectively measured sleep duration and the risk of cardiometabolic disease.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38268197/

Sleep extension and cardiometabolic health: what it ... - PubMed Short sleep duration is associated with heightened cardiometabolic disease risk and has reached epidemic proportions among children, adolescents and adults.