- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05880758
Impact of Yo-Yo Sleep on Cardiometabolic Health
March 22, 2024 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
Recruiting
Conditions
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
Interventional
Enrollment (Estimated)
72
Phase
- 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
- Name: Marie-Pierre St-Onge, PhD
- Phone Number: 212-305-9549
- Email: ms2554@cumc.columbia.edu
Study Contact Backup
- Name: Greiby Mercedes
- Phone Number: 646-761-3455
- Email: gdm2130@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- Columbia University Irving Medical Center
-
Principal Investigator:
- Marie-Pierre St-Onge, PhD
-
Contact:
- Marie-Pierre St-Onge, PhD
- Phone Number: 212-305-9549
- Email: ms2554@cumc.columbia.edu
-
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
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 |
Intervention / Treatment |
---|---|
Active Comparator: Stable Adequate Sleep (SAS)
Participants will go to bed and wake up at the same time every night, maintaining adequate sleep duration.
|
Goal of ≥7 hours of sleep/night with 8 hours of time in bed (TIB).
Other Names:
|
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
|
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:
|
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
|
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:
2-hour delayed sleep timing.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
Collaborators
Investigators
- 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)
September 22, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
June 1, 2028
Study Registration Dates
First Submitted
May 17, 2023
First Submitted That Met QC Criteria
May 25, 2023
First Posted (Actual)
May 30, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 22, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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