Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT05880758

Conditions

Cardiometabolic Syndrome

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

Intermittent Short Sleep (ISS)

Social Jetlag (SJL)

Sustained Adequate Sleep (SAS)

Study Details

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).

Conditions

Cardiometabolic Syndrome

Obesity

Study ID

NCT05880758

Start date

Sep 22, 2023

Status verified date

May, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 49

Healthy Volunteers: Accepted

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 Design

Enrollment

72 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Stable Adequate Sleep (SAS)

Participants will go to bed and wake up at the same time every night, maintaining adequate sleep duration.

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

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

Interventions

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.

Social Jetlag (SJL)

2-hour delayed sleep timing.

Sustained Adequate Sleep (SAS)

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

Primary outcome measure

  • Fasting Plasma Glucose [ Time Frame: Up to 4 weeks ]
  • Insulin Level [ Time Frame: Up to 4 weeks ]
  • Morning Systolic and Diastolic Blood Pressure [ Time Frame: Up to 4 weeks ]
  • Evening Systolic and Diastolic Blood Pressure [ Time Frame: Up to 4 weeks ]
  • Fat mass [ Time Frame: Up to 4 weeks ]

Central Contacts and Locations

Central contacts

Marie-Pierre St-Onge, PhD

212-305-9549ms2554@cumc.columbia.edu

Greiby Mercedes

646-761-3455gdm2130@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Marie-Pierre St-Onge, PhD

212-305-9549ms2554@cumc.columbia.edu

Principal Investigator:

Marie-Pierre St-Onge, PhD

More Information

Sponsor

Columbia University

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

  • Sleep
  • Circadian Rhythms
  • Cardiometabolic Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-05-18.