Impact of Yo-Yo Sleep on Cardiometabolic Health

NCT ID: NCT05880758

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-22

Study Completion Date

2028-06-30

Brief Summary

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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

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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

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Cardiometabolic Syndrome Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3-arm, parallel study design
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
Statistician will be blinded to intervention allocation; blinding of study participants is not possible due to the intervention type.

Study Groups

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Stable Adequate Sleep (SAS)

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

Group Type ACTIVE_COMPARATOR

Sustained Adequate Sleep (SAS)

Intervention Type BEHAVIORAL

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

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

Group Type EXPERIMENTAL

Intermittent Short Sleep (ISS)

Intervention Type BEHAVIORAL

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.

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

Group Type EXPERIMENTAL

Intermittent Short Sleep (ISS)

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

2-hour delayed sleep timing.

Interventions

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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.

Intervention Type BEHAVIORAL

Social Jetlag (SJL)

2-hour delayed sleep timing.

Intervention Type BEHAVIORAL

Sustained Adequate Sleep (SAS)

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

Intervention Type BEHAVIORAL

Other Intervention Names

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ISS SJL SAS

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Marie-Pierre St-Onge

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie-Pierre St-Onge, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University Irving Medical Center

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marie-Pierre St-Onge, PhD

Role: CONTACT

212-305-9549

Greiby Mercedes

Role: CONTACT

646-761-3455

Facility Contacts

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Marie-Pierre St-Onge, PhD

Role: primary

212-305-9549

Other Identifiers

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R35HL155670

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAU3694

Identifier Type: -

Identifier Source: org_study_id

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