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NCT Number: NCT05880758

Impact of Yo-Yo Sleep on Cardiometabolic Health

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).

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Marie-Pierre St-Onge, PhD

CONTACT

[email protected]

212-305-9549

Marie-Pierre St-Onge, PhD

PRINCIPAL_INVESTIGATOR

Sanja Jelic, MD

SUB_INVESTIGATOR

About this study

A large portion of the U.S. adult population reports insufficient sleep on a nightly basis. It has been shown that sustained insufficient sleep leads to adverse cardiometabolic risk profile and positive energy balance. However, sleep patterns in real life are not consistent over weeks. Individuals not obtaining sufficient sleep during the week may compensate by sleeping longer on weekends. The differences in sleep duration between week and weekend nights is approximately 1 hour, mostly due to delaying wake times rather than advancing bedtimes. A drawback of such behaviors is resultant change in sleep midpoint, which has been associated with adverse cardiometabolic health and obesity. However, very few studies have attempted to determine whether recovery sleep on weekends results in reversal of adverse health effects of insufficient sleep during the week. Available studies suggest that recovery sleep does not revert health markers to pre-sleep restriction (SR) levels. But these studies are short, usually involving only one cycle of SR followed by recovery sleep, and fail to use appropriate and robust statistical methods. Therefore, the goal of the current investigation is to evaluate the impact of repeated intermittent short sleep, with short sleep maintained 5 days/week followed by 2 days of recovery sleep, relative to daily adequate sleep, on energy balance and cardiometabolic risk markers. A secondary goal of this research is to determine if maintaining a constant sleep timing while undergoing intermittent short sleep, leads to better outcomes than intermittent short sleep in conjunction with shifts in sleep times.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 to 49 years
  • BMI 20-29.9 kg/m2
  • Habitually sleeping 7-9 hours/night without sleep aids or naps

Exclusion criteria

  • Sleep disorders
  • Psychiatric disorders (including eating disorders) and seasonal affective disorder
  • Pregnancy (current/prior year)
  • Breastfeeding
  • Smokers (Any cigarette smoking or ex-smokers <3years)
  • Diabetes
  • Elevated blood pressure, taking beta-blockers
  • Individuals taking anti-coagulants or anti-platelets
  • Recent weight change or participation in a weight loss program or have ever had bariatric surgery or other weight loss or gastrointestinal procedure.
  • Travel across time zones; shift work (non-traditional hours)

Treatment and study plan

Intermittent Short Sleep (ISS)

Behavioral

Restricted sleep duration of <5.5 h/night for 5 nights (SR) followed by 2 nights of 9.5 hours of time in bed (TIB) (recover sleep) each week.

Other names: ISS

Social Jetlag (SJL)

Behavioral

2-hour delayed sleep timing.

Other names: SJL

Sustained Adequate Sleep (SAS)

Behavioral

Goal of ≥7 hours of sleep/night with 8 hours of time in bed (TIB).

Other names: SAS

Primary outcomes

  1. Fasting Plasma Glucose

    Time frame: Up to 4 weeks

    Insulin resistance will be assessed by measuring fasting plasma glucose levels.

  2. Insulin Level

    Time frame: Up to 4 weeks

    Insulin resistance will be assessed by measuring insulin levels.

  3. Morning Systolic and Diastolic Blood Pressure

    Time frame: Up to 4 weeks

    Ambulatory blood pressure will be measured.

  4. Evening Systolic and Diastolic Blood Pressure

    Time frame: Up to 4 weeks

    Ambulatory blood pressure will be measured.

  5. Fat mass

    Time frame: Up to 4 weeks

    Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass.

Secondary outcomes

  1. Low-density Lipoprotein (LDL) Level

    Time frame: Up to 4 weeks

    Lipid panel will be assessed.

  2. High-density Lipoprotein (HDL) Level

    Time frame: Up to 4 weeks

    Lipid panel will be assessed.

  3. Total Cholesterol Level

    Time frame: Up to 4 weeks

    Lipid panel will be assessed.

  4. Triglyceride Level

    Time frame: Up to 4 weeks

    Lipid panel will be assessed.

  5. C-reactive protein (CRP) Level

    Time frame: Up to 4 weeks

    CRP will be measured as an inflammatory marker.

  6. Interleukin 6 (IL-6)

    Time frame: Up to 4 weeks

    IL-6 will be measured as an inflammatory marker.

  7. Tumor necrosis factor alpha (TNF-alpha)

    Time frame: Up to 4 weeks

    TNF-alpha will be measured as an inflammatory marker.

  8. Total daily energy expenditure

    Time frame: Baseline and endpoint (4 weeks)

    Energy expenditure will be measured using doubly-labeled water over 14 days

  9. Energy Intake

    Time frame: Baseline and endpoint (4 weeks)

    Energy intake will be measured to assess diet quality using daily food records for 7 days.

  10. Total Ghrelin

    Time frame: 2 hours post meal at baseline and endpoint (4 weeks)

    Total ghrelin will be assessed using radioimmunoassay (RIA).

  11. Serum Leptin

    Time frame: 2 hours post meal at baseline and endpoint (4 weeks)

    Serum leptin will be measured using a double-antibody RIA.

  12. Adiponectin Level

    Time frame: Up to 4 weeks

    Adiponectin levels will be analyzed using RIA.

  13. Glucagon-like peptide 1 (GLP-1) Level

    Time frame: 2 hours post meal at baseline and endpoint (4 weeks)

    GLP-1 will be measured by RIA after plasma extraction with 95% ethanol.

  14. Change in Nuclear factor kappa B (NFkB) Level

    Time frame: Baseline and endpoint (4 weeks)

    NFkB will be measured to assess endothelial cell inflammation.

Study contacts

Contact information is provided by the study sponsor or research team.

Greiby Mercedes

CONTACT

[email protected]

646-761-3455

Marie-Pierre St-Onge, PhD

CONTACT

[email protected]

212-305-9549

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Icahn School of Medicine at Mount Sinai
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Colorado, Denver

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
May 30, 2023
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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