Cardiometabolic SyndromeNCT05880758
Impact of Yo-Yo Sleep on Cardiometabolic Health
A study testing Intermittent Short Sleep (ISS), Social Jetlag (SJL) and Sustained Adequate Sleep (SAS) in people with Cardiometabolic Syndrome and Obesity, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Syndrome, Obesity
- What is being tested?
- Intermittent Short Sleep (ISS), Social Jetlag (SJL) and Sustained Adequate Sleep (SAS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2023to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 49 years
- BMI 20-29.9 kg/m2
- Habitually sleeping 7-9 hours/night without sleep aids or naps
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Marie-Pierre St-Onge, PhD, 212-305-9549, ms2554@cumc.columbia.edu
Marie-Pierre St-Onge, PhD
About this study
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).
Read the 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.
- Conditions
- Cardiometabolic Syndrome, Obesity
- Being tested
- Intermittent Short Sleep (ISS), Social Jetlag (SJL), Sustained Adequate Sleep (SAS)
- Keywords
- Sleep, Circadian Rhythms, Cardiometabolic Health
- Medical subject headings
- Metabolic Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Short Sleep (ISS)Behavioural
Also called 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.
Social Jetlag (SJL)Behavioural
Also called SJL
2-hour delayed sleep timing.
Sustained Adequate Sleep (SAS)Behavioural
Also called SAS
Goal of ≥7 hours of sleep/night with 8 hours of time in bed (TIB).
| Study group | Role | What they receive |
|---|---|---|
| Stable Adequate Sleep (SAS) | Active comparator | Participants will go to bed and wake up at the same time every night, maintaining adequate sleep duration. Receives: Behavioral: Sustained Adequate Sleep (SAS) |
| ISS_Alone | Experimental | 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 Receives: Behavioral: Intermittent Short Sleep (ISS) |
| ISS_SJL | Experimental | 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 Receives: Behavioral: Intermittent Short Sleep (ISS); Behavioral: Social Jetlag (SJL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting Plasma Glucose
Insulin resistance will be assessed by measuring fasting plasma glucose levels.
Measured: Up to 4 weeks
Insulin Level
Insulin resistance will be assessed by measuring insulin levels.
Measured: Up to 4 weeks
Morning Systolic and Diastolic Blood Pressure
Ambulatory blood pressure will be measured.
Measured: Up to 4 weeks
Evening Systolic and Diastolic Blood Pressure
Ambulatory blood pressure will be measured.
Measured: Up to 4 weeks
Fat mass
Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass.
Measured: Up to 4 weeks
Secondary outcomes (14)
Low-density Lipoprotein (LDL) Level
Lipid panel will be assessed.
Measured: Up to 4 weeks
High-density Lipoprotein (HDL) Level
Lipid panel will be assessed.
Measured: Up to 4 weeks
Total Cholesterol Level
Lipid panel will be assessed.
Measured: Up to 4 weeks
Triglyceride Level
Lipid panel will be assessed.
Measured: Up to 4 weeks
C-reactive protein (CRP) Level
CRP will be measured as an inflammatory marker.
Measured: Up to 4 weeks
Interleukin 6 (IL-6)
IL-6 will be measured as an inflammatory marker.
Measured: Up to 4 weeks
Tumor necrosis factor alpha (TNF-alpha)
TNF-alpha will be measured as an inflammatory marker.
Measured: Up to 4 weeks
Total daily energy expenditure
Energy expenditure will be measured using doubly-labeled water over 14 days
Measured: Baseline and endpoint (4 weeks)
Energy Intake
Energy intake will be measured to assess diet quality using daily food records for 7 days.
Measured: Baseline and endpoint (4 weeks)
Total Ghrelin
Total ghrelin will be assessed using radioimmunoassay (RIA).
Measured: 2 hours post meal at baseline and endpoint (4 weeks)
Serum Leptin
Serum leptin will be measured using a double-antibody RIA.
Measured: 2 hours post meal at baseline and endpoint (4 weeks)
Adiponectin Level
Adiponectin levels will be analyzed using RIA.
Measured: Up to 4 weeks
Glucagon-like peptide 1 (GLP-1) Level
GLP-1 will be measured by RIA after plasma extraction with 95% ethanol.
Measured: 2 hours post meal at baseline and endpoint (4 weeks)
Change in Nuclear factor kappa B (NFkB) Level
NFkB will be measured to assess endothelial cell inflammation.
Measured: Baseline and endpoint (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start22 Sep 2023
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3-arm, parallel study design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, University of Colorado, Denver, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Marie-Pierre St-Onge, Columbia University
- Investigators
- Marie-Pierre St-Onge, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880758
- Sponsor's protocol ID
- AAAU3694
- Other IDs
- R35HL155670
- Status last verified
- May 2026
- First submitted
- 17 May 2023
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Yo-Yo Sleep on Cardiometabolic Health
- ClinicalTrials.gov ID
- NCT05880758
- Acronym / sponsor ID
- AAAU3694
- Conditions
- Cardiometabolic Syndrome, Obesity
- Keywords
- Sleep, Circadian Rhythms, Cardiometabolic Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, University of Colorado, Denver, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 22 Sep 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3-arm, parallel study design
| Arm | Type | Receives |
|---|---|---|
| Stable Adequate Sleep (SAS) | Active comparator | Behavioral: Sustained Adequate Sleep (SAS)Participants will go to bed and wake up at the same time every night, maintaining adequate sleep duration. |
| ISS_Alone | Experimental | Behavioral: Intermittent Short Sleep (ISS)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 |
| ISS_SJL | Experimental | Behavioral: Intermittent Short Sleep (ISS), Behavioral: Social Jetlag (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 |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18 to 49 years
- BMI 20-29.9 kg/m2
- Habitually sleeping 7-9 hours/night without sleep aids or naps
Key exclusion criteria (10 listed)
- Sleep disorders
- Psychiatric disorders (including eating disorders) and seasonal affective disorder
- Pregnancy (current/prior year)
- Breastfeeding
- Smokers (Any cigarette smoking or ex-smokers <3years)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Short Sleep (ISS)Also: ISSRestricted 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. | Behavioural | ISS_Alone, ISS_SJL |
| Social Jetlag (SJL)Also: SJL2-hour delayed sleep timing. | Behavioural | ISS_SJL |
| Sustained Adequate Sleep (SAS)Also: SASGoal of ≥7 hours of sleep/night with 8 hours of time in bed (TIB). | Behavioural | Stable Adequate Sleep (SAS) |
Primary outcome
Fasting Plasma Glucose
Time frame: Up to 4 weeks
Insulin resistance will be assessed by measuring fasting plasma glucose levels.
Insulin Level
Time frame: Up to 4 weeks
Insulin resistance will be assessed by measuring insulin levels.
Morning Systolic and Diastolic Blood Pressure
Time frame: Up to 4 weeks
Ambulatory blood pressure will be measured.
Evening Systolic and Diastolic Blood Pressure
Time frame: Up to 4 weeks
Ambulatory blood pressure will be measured.
Fat mass
Time frame: Up to 4 weeks
Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass.
14 secondary outcomes
Low-density Lipoprotein (LDL) Level
Time frame: Up to 4 weeks
High-density Lipoprotein (HDL) Level
Time frame: Up to 4 weeks
Total Cholesterol Level
Time frame: Up to 4 weeks
Triglyceride Level
Time frame: Up to 4 weeks
C-reactive protein (CRP) Level
Time frame: Up to 4 weeks
Interleukin 6 (IL-6)
Time frame: Up to 4 weeks
Tumor necrosis factor alpha (TNF-alpha)
Time frame: Up to 4 weeks
Total daily energy expenditure
Time frame: Baseline and endpoint (4 weeks)
Energy Intake
Time frame: Baseline and endpoint (4 weeks)
Total Ghrelin
Time frame: 2 hours post meal at baseline and endpoint (4 weeks)
Serum Leptin
Time frame: 2 hours post meal at baseline and endpoint (4 weeks)
Adiponectin Level
Time frame: Up to 4 weeks
Glucagon-like peptide 1 (GLP-1) Level
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Pierre St-Onge, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Short Sleep (ISS), Social Jetlag (SJL) and Sustained Adequate Sleep (SAS) in people with Cardiometabolic Syndrome and Obesity, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Pierre St-Onge, PhD (212-305-9549, ms2554@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting Plasma Glucose (time frame: Up to 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.