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| ID | Type | Description | Link |
|---|---|---|---|
| R35HL155670 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
| University of Colorado, Denver | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stable Adequate Sleep (SAS) | Active Comparator | Participants will go to bed and wake up at the same time every night, maintaining adequate sleep duration. |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Short Sleep (ISS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Plasma Glucose | Insulin resistance will be assessed by measuring fasting plasma glucose levels. | Up to 4 weeks |
| Insulin Level | Insulin resistance will be assessed by measuring insulin levels. | Up to 4 weeks |
| Morning Systolic and Diastolic Blood Pressure | Ambulatory blood pressure will be measured. | Up to 4 weeks |
| Evening Systolic and Diastolic Blood Pressure | Ambulatory blood pressure will be measured. | Up to 4 weeks |
| Fat mass | Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass. | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Low-density Lipoprotein (LDL) Level | Lipid panel will be assessed. | Up to 4 weeks |
| High-density Lipoprotein (HDL) Level | Lipid panel will be assessed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie-Pierre St-Onge, PhD | Contact | 212-305-9549 | ms2554@cumc.columbia.edu | |
| Greiby Mercedes | Contact | 646-761-3455 | gdm2130@cumc.columbia.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marie-Pierre St-Onge, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
Data from this study will be available for sharing with other investigators. Data sharing requests should be made in writing and sent directly to the investigator(s) who generated the data. The purposes for using shared data should be stated in the request, and the data can only be used for research purposes. Data sharing agreements should be developed and accepted by both parties before data sharing takes place. Protecting the rights and privacy of human subjects and maintaining the study participants' confidentiality will be the first priority of our data sharing plan. HIPAA privacy rule for de-identification of a dataset will be followed before transferring data.
Data will become available after results of the main aims from the final dataset have been accepted for publication.
Contact PI for information on data availability and data sharing.
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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3-arm, parallel study design
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Statistician will be blinded to intervention allocation; blinding of study participants is not possible due to the intervention type.
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| Social Jetlag (SJL) | Behavioral | 2-hour delayed sleep timing. |
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| Sustained Adequate Sleep (SAS) | Behavioral | Goal of ≥7 hours of sleep/night with 8 hours of time in bed (TIB). |
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| Up to 4 weeks |
| Total Cholesterol Level | Lipid panel will be assessed. | Up to 4 weeks |
| Triglyceride Level | Lipid panel will be assessed. | Up to 4 weeks |
| C-reactive protein (CRP) Level | CRP will be measured as an inflammatory marker. | Up to 4 weeks |
| Interleukin 6 (IL-6) | IL-6 will be measured as an inflammatory marker. | Up to 4 weeks |
| Tumor necrosis factor alpha (TNF-alpha) | TNF-alpha will be measured as an inflammatory marker. | Up to 4 weeks |
| Total daily energy expenditure | Energy expenditure will be measured using doubly-labeled water over 14 days | Baseline and endpoint (4 weeks) |
| Energy Intake | Energy intake will be measured to assess diet quality using daily food records for 7 days. | Baseline and endpoint (4 weeks) |
| Total Ghrelin | Total ghrelin will be assessed using radioimmunoassay (RIA). | 2 hours post meal at baseline and endpoint (4 weeks) |
| Serum Leptin | Serum leptin will be measured using a double-antibody RIA. | 2 hours post meal at baseline and endpoint (4 weeks) |
| Adiponectin Level | Adiponectin levels will be analyzed using RIA. | Up to 4 weeks |
| 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) |
| Change in Nuclear factor kappa B (NFkB) Level | NFkB will be measured to assess endothelial cell inflammation. | Baseline and endpoint (4 weeks) |
| D009750 |
| Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |