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Varied Sleep Patterns for Cardiometabolic Health

N/A

Recruiting

Led By Marie-Pierre St-Onge, PhD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Habitually sleeping 7-9 hours/night without sleep aids or naps

Aged 18 to 49 years

Must not have

Individuals taking anti-coagulants or anti-platelets

Psychiatric disorders (including eating disorders) and seasonal affective disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours post meal at baseline and endpoint (4 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the effects of repeated short sleep and delayed sleep midpoint on energy balance and heart health in young to middle-aged adults.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While this trial does not involve medication that typically has side effects like drugs do, participants may experience fatigue or stress due to altered sleeping patterns which could potentially impact mood and alertness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 49 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking blood thinners.

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I have a psychiatric or eating disorder, or seasonal affective disorder.

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I have diabetes.

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I have high blood pressure and am taking beta-blockers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours post meal at baseline and endpoint (4 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hours post meal at baseline and endpoint (4 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours post meal at baseline and endpoint (4 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Evening Systolic and Diastolic Blood Pressure

Fasting Plasma Glucose

Fat mass

+2 more

Secondary study objectives

Adiponectin Level

C-reactive protein (CRP) Level

Change in Nuclear factor kappa B (NFkB) Level

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: ISS_SJLExperimental Treatment2 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_AloneExperimental Treatment1 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 Control1 Intervention

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

0 / 6Eligibility criteria met