Impact of Yo-Yo Sleep on Cardiometabolic Health

May 14, 2026 updated by: Marie-Pierre St-Onge, Columbia University
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Principal Investigator:
          • Marie-Pierre St-Onge, PhD
        • Contact:
        • Sub-Investigator:
          • Sanja Jelic, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Stable Adequate Sleep (SAS)
Participants will go to bed and wake up at the same time every night, maintaining adequate sleep duration.
Behavioral: Sustained Adequate Sleep (SAS)
Goal of ≥7 hours of sleep/night with 8 hours of time in bed (TIB).
Other Names:
  • SAS
Experimental: ISS_Alone
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
Behavioral: Intermittent Short Sleep (ISS)
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
Experimental: ISS_SJL
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
Behavioral: Intermittent Short Sleep (ISS)
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
Behavioral: Social Jetlag (SJL)
2-hour delayed sleep timing.
Other Names:
  • SJL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fasting Plasma Glucose
Time Frame: Up to 4 weeks
Insulin resistance will be assessed by measuring fasting plasma glucose levels.
Up to 4 weeks
Insulin Level
Time Frame: Up to 4 weeks
Insulin resistance will be assessed by measuring insulin levels.
Up to 4 weeks
Morning Systolic and Diastolic Blood Pressure
Time Frame: Up to 4 weeks
Ambulatory blood pressure will be measured.
Up to 4 weeks
Evening Systolic and Diastolic Blood Pressure
Time Frame: Up to 4 weeks
Ambulatory blood pressure will be measured.
Up to 4 weeks
Fat mass
Time Frame: Up to 4 weeks
Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass.
Up to 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Low-density Lipoprotein (LDL) Level
Time Frame: Up to 4 weeks
Lipid panel will be assessed.
Up to 4 weeks
High-density Lipoprotein (HDL) Level
Time Frame: Up to 4 weeks
Lipid panel will be assessed.
Up to 4 weeks
Total Cholesterol Level
Time Frame: Up to 4 weeks
Lipid panel will be assessed.
Up to 4 weeks
Triglyceride Level
Time Frame: Up to 4 weeks
Lipid panel will be assessed.
Up to 4 weeks
C-reactive protein (CRP) Level
Time Frame: Up to 4 weeks
CRP will be measured as an inflammatory marker.
Up to 4 weeks
Interleukin 6 (IL-6)
Time Frame: Up to 4 weeks
IL-6 will be measured as an inflammatory marker.
Up to 4 weeks
Tumor necrosis factor alpha (TNF-alpha)
Time Frame: Up to 4 weeks
TNF-alpha will be measured as an inflammatory marker.
Up to 4 weeks
Total daily energy expenditure
Time Frame: Baseline and endpoint (4 weeks)
Energy expenditure will be measured using doubly-labeled water over 14 days
Baseline and endpoint (4 weeks)
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.
Baseline and endpoint (4 weeks)
Total Ghrelin
Time Frame: 2 hours post meal at baseline and endpoint (4 weeks)
Total ghrelin will be assessed using radioimmunoassay (RIA).
2 hours post meal at baseline and endpoint (4 weeks)
Serum Leptin
Time Frame: 2 hours post meal at baseline and endpoint (4 weeks)
Serum leptin will be measured using a double-antibody RIA.
2 hours post meal at baseline and endpoint (4 weeks)
Adiponectin Level
Time Frame: Up to 4 weeks
Adiponectin levels will be analyzed using RIA.
Up to 4 weeks
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.
2 hours post meal at baseline and endpoint (4 weeks)
Change in Nuclear factor kappa B (NFkB) Level
Time Frame: Baseline and endpoint (4 weeks)
NFkB will be measured to assess endothelial cell inflammation.
Baseline and endpoint (4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Colorado, Denver
National Heart, Lung, and Blood Institute (NHLBI)
Icahn School of Medicine at Mount Sinai

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marie-Pierre St-Onge, PhD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAU3694
  • R35HL155670 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data from this study will be available for sharing with other investigators. Data sharing requests should be made in writing and sent directly to the investigator(s) who generated the data. The purposes for using shared data should be stated in the request, and the data can only be used for research purposes. Data sharing agreements should be developed and accepted by both parties before data sharing takes place. Protecting the rights and privacy of human subjects and maintaining the study participants' confidentiality will be the first priority of our data sharing plan. HIPAA privacy rule for de-identification of a dataset will be followed before transferring data.

IPD Sharing Time Frame

Data will become available after results of the main aims from the final dataset have been accepted for publication.

IPD Sharing Access Criteria

Contact PI for information on data availability and data sharing.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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