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Clinical Trials/NCT05880758
NCT05880758RecruitingNot Applicable

Impact of Yo-Yo Sleep on Cardiometabolic Health

Columbia University2 sites in 1 country72 target enrollmentStarted: September 22, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
72
Locations
2
Primary Endpoint
Morning Systolic and Diastolic Blood Pressure

Study Overview

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).

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Single (Outcomes Assessor)

Masking Description

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

Eligibility Criteria

Ages
18 Years to 49 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)
  • 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)

Arms & Interventions

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

Intervention: Intermittent Short Sleep (ISS) (Behavioral)

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

Intervention: Intermittent Short Sleep (ISS) (Behavioral)

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

Intervention: Social Jetlag (SJL) (Behavioral)

Stable Adequate Sleep (SAS)

Active Comparator

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

Intervention: Sustained Adequate Sleep (SAS) (Behavioral)

Outcomes

Primary Outcomes

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.

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.

Fat mass

Time Frame: Up to 4 weeks

Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass.

Secondary Outcomes

  • Interleukin 6 (IL-6)(Up to 4 weeks)
  • Tumor necrosis factor alpha (TNF-alpha)(Up to 4 weeks)
  • Total daily energy expenditure(Baseline and endpoint (4 weeks))
  • Energy Intake(Baseline and endpoint (4 weeks))
  • Adiponectin Level(Up to 4 weeks)
  • Total Ghrelin(2 hours post meal at baseline and endpoint (4 weeks))
  • Serum Leptin(2 hours post meal at baseline and endpoint (4 weeks))
  • 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)
  • Glucagon-like peptide 1 (GLP-1) Level(2 hours post meal at baseline and endpoint (4 weeks))
  • Change in Nuclear factor kappa B (NFkB) Level(Baseline and endpoint (4 weeks))
  • Triglyceride Level(Up to 4 weeks)
  • C-reactive protein (CRP) Level(Up to 4 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Marie-Pierre St-Onge

Associate Professor

Columbia University

Study Sites (2)

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