Columbia University Irving Medical Center
New York, 10032, United States
Location status: Recruiting
Location contact
Marie-Pierre St-Onge, PhD
CONTACT
Marie-Pierre St-Onge, PhD
PRINCIPAL_INVESTIGATOR
Sanja Jelic, MD
SUB_INVESTIGATOR
NCT Number: NCT05880758
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).
Interested in participating?
Request Info18 year–49 year
All sexes
Interventional
Not applicable
New York, 10032, United States
Location status: Recruiting
Marie-Pierre St-Onge, PhD
CONTACT
Marie-Pierre St-Onge, PhD
PRINCIPAL_INVESTIGATOR
Sanja Jelic, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: ISS
2-hour delayed sleep timing.
Other names: SJL
Goal of ≥7 hours of sleep/night with 8 hours of time in bed (TIB).
Other names: SAS
Time frame: Up to 4 weeks
Insulin resistance will be assessed by measuring fasting plasma glucose levels.
Time frame: Up to 4 weeks
Insulin resistance will be assessed by measuring insulin levels.
Time frame: Up to 4 weeks
Ambulatory blood pressure will be measured.
Time frame: Up to 4 weeks
Ambulatory blood pressure will be measured.
Time frame: Up to 4 weeks
Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass.
Time frame: Up to 4 weeks
Lipid panel will be assessed.
Time frame: Up to 4 weeks
Lipid panel will be assessed.
Time frame: Up to 4 weeks
Lipid panel will be assessed.
Time frame: Up to 4 weeks
Lipid panel will be assessed.
Time frame: Up to 4 weeks
CRP will be measured as an inflammatory marker.
Time frame: Up to 4 weeks
IL-6 will be measured as an inflammatory marker.
Time frame: Up to 4 weeks
TNF-alpha will be measured as an inflammatory marker.
Time frame: Baseline and endpoint (4 weeks)
Energy expenditure will be measured using doubly-labeled water over 14 days
Time frame: Baseline and endpoint (4 weeks)
Energy intake will be measured to assess diet quality using daily food records for 7 days.
Time frame: 2 hours post meal at baseline and endpoint (4 weeks)
Total ghrelin will be assessed using radioimmunoassay (RIA).
Time frame: 2 hours post meal at baseline and endpoint (4 weeks)
Serum leptin will be measured using a double-antibody RIA.
Time frame: Up to 4 weeks
Adiponectin levels will be analyzed using RIA.
Time frame: 2 hours post meal at baseline and endpoint (4 weeks)
GLP-1 will be measured by RIA after plasma extraction with 95% ethanol.
Time frame: Baseline and endpoint (4 weeks)
NFkB will be measured to assess endothelial cell inflammation.
Contact information is provided by the study sponsor or research team.
Greiby Mercedes
CONTACT
Marie-Pierre St-Onge, PhD
CONTACT
Columbia University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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