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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05880758
Other study ID # AAAU3694
Secondary ID R35HL155670
Status Recruiting
Phase N/A
First received
Last updated
Start date September 22, 2023
Est. completion date June 2028

Study information

Verified date March 2024
Source Columbia University
Contact Marie-Pierre St-Onge, PhD
Phone 212-305-9549
Email ms2554@cumc.columbia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date June 2028
Est. primary completion date December 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 49 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Behavioral:
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).

Locations

Country Name City State
United States Columbia University Irving Medical Center New York New York

Sponsors (4)

Lead Sponsor Collaborator
Columbia University Icahn School of Medicine at Mount Sinai, National Heart, Lung, and Blood Institute (NHLBI), University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fasting Plasma Glucose Insulin resistance will be assessed by measuring fasting plasma glucose levels. Up to 4 weeks
Primary Insulin Level Insulin resistance will be assessed by measuring insulin levels. Up to 4 weeks
Primary Morning Systolic and Diastolic Blood Pressure Ambulatory blood pressure will be measured. Up to 4 weeks
Primary Evening Systolic and Diastolic Blood Pressure Ambulatory blood pressure will be measured. Up to 4 weeks
Primary Fat mass Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass. Up to 4 weeks
Secondary Low-density Lipoprotein (LDL) Level Lipid panel will be assessed. Up to 4 weeks
Secondary High-density Lipoprotein (HDL) Level Lipid panel will be assessed. Up to 4 weeks
Secondary Total Cholesterol Level Lipid panel will be assessed. Up to 4 weeks
Secondary Triglyceride Level Lipid panel will be assessed. Up to 4 weeks
Secondary C-reactive protein (CRP) Level CRP will be measured as an inflammatory marker. Up to 4 weeks
Secondary Interleukin 6 (IL-6) IL-6 will be measured as an inflammatory marker. Up to 4 weeks
Secondary Tumor necrosis factor alpha (TNF-alpha) TNF-alpha will be measured as an inflammatory marker. Up to 4 weeks
Secondary Total daily energy expenditure Energy expenditure will be measured using doubly-labeled water over 14 days Baseline and endpoint (4 weeks)
Secondary Energy Intake Energy intake will be measured to assess diet quality using daily food records for 7 days. Baseline and endpoint (4 weeks)
Secondary Total Ghrelin Total ghrelin will be assessed using radioimmunoassay (RIA). 2 hours post meal at baseline and endpoint (4 weeks)
Secondary Serum Leptin Serum leptin will be measured using a double-antibody RIA. 2 hours post meal at baseline and endpoint (4 weeks)
Secondary Adiponectin Level Adiponectin levels will be analyzed using RIA. Up to 4 weeks
Secondary Glucagon-like peptide 1 (GLP-1) Level GLP-1 will be measured by RIA after plasma extraction with 95% ethanol. 2 hours post meal at baseline and endpoint (4 weeks)
Secondary Change in Nuclear factor kappa B (NFkB) Level NFkB will be measured to assess endothelial cell inflammation. Baseline and endpoint (4 weeks)
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