Impact of Yo-Yo Sleep on Cardiometabolic Health
2 other identifiers
interventional
72
1 country
1
Brief 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. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2023
CompletedFirst Posted
Study publicly available on registry
May 30, 2023
CompletedStudy Start
First participant enrolled
September 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
May 14, 2025
May 1, 2025
4.2 years
May 17, 2023
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Fasting Plasma Glucose
Insulin resistance will be assessed by measuring fasting plasma glucose levels.
Up to 4 weeks
Insulin Level
Insulin resistance will be assessed by measuring insulin levels.
Up to 4 weeks
Morning Systolic and Diastolic Blood Pressure
Ambulatory blood pressure will be measured.
Up to 4 weeks
Evening Systolic and Diastolic Blood Pressure
Ambulatory blood pressure will be measured.
Up to 4 weeks
Fat mass
Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass.
Up to 4 weeks
Secondary Outcomes (14)
Low-density Lipoprotein (LDL) Level
Up to 4 weeks
High-density Lipoprotein (HDL) Level
Up to 4 weeks
Total Cholesterol Level
Up to 4 weeks
Triglyceride Level
Up to 4 weeks
C-reactive protein (CRP) Level
Up to 4 weeks
- +9 more secondary outcomes
Study Arms (3)
Stable Adequate Sleep (SAS)
ACTIVE COMPARATORParticipants will go to bed and wake up at the same time every night, maintaining adequate sleep duration.
ISS_Alone
EXPERIMENTALIntermittent 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
EXPERIMENTALIntermittent 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
Interventions
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.
Goal of ≥7 hours of sleep/night with 8 hours of time in bed (TIB).
Eligibility Criteria
You may qualify if:
- Aged 18 to 49 years
- BMI 20-29.9 kg/m2
- Habitually sleeping 7-9 hours/night without sleep aids or naps
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- Icahn School of Medicine at Mount Sinaicollaborator
- University of Colorado, Denvercollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
Columbia University Irving Medical Center
New York, New York, 10032, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marie-Pierre St-Onge, PhD
Columbia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Statistician will be blinded to intervention allocation; blinding of study participants is not possible due to the intervention type.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 17, 2023
First Posted
May 30, 2023
Study Start
September 22, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
June 1, 2028
Last Updated
May 14, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will become available after results of the main aims from the final dataset have been accepted for publication.
- Access Criteria
- Contact PI for information on data availability and data sharing.
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.