Impact of Yo-Yo Sleep on Cardiometabolic Health

Study Overview
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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 8 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.

Official Title
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Impact of Yo-Yo Sleep on Cardiometabolic Health

Conditions
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Cardiometabolic Syndrome, Obesity

Intervention / Treatment
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* Behavioral: Intermittent Short Sleep (ISS)
* Behavioral: Social Jetlag (SJL)
* Behavioral: Sustained Adequate Sleep (SAS)


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3-arm, parallel study design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stable Adequate Sleep (SAS)<br>Participants will go to bed and wake up at the same time every night, maintaining adequate sleep duration. | Behavioral: Sustained Adequate Sleep (SAS)<br>* Goal of ≥7 hours of sleep/night with 8 hours of time in bed (TIB).<br>* Other names: SAS;|
| Experimental: ISS_Alone<br>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 | Behavioral: Intermittent Short Sleep (ISS)<br>* 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.<br>* Other names: ISS;|
| Experimental: ISS_SJL<br>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 | Behavioral: Intermittent Short Sleep (ISS)<br>* 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.<br>* Other names: ISS;Behavioral: Social Jetlag (SJL)<br>* 2-hour delayed sleep timing.<br>* Other names: SJL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose | Insulin resistance will be assessed by measuring fasting plasma glucose levels. | Up to 8 weeks | 
| Insulin Level | Insulin resistance will be assessed by measuring insulin levels. | Up to 8 weeks | 
| Morning Systolic and Diastolic Blood Pressure | Ambulatory blood pressure will be measured. | Up to 8 weeks | 
| Evening Systolic and Diastolic Blood Pressure | Ambulatory blood pressure will be measured. | Up to 8 weeks | 
| Fat mass | Body composition will be measured using Dual-energy X-ray absorptiometry (DXA) to determine fat mass. | Up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low-density Lipoprotein (LDL) Level | Lipid panel will be assessed. | Up to 8 weeks | 
| High-density Lipoprotein (HDL) Level | Lipid panel will be assessed. | Up to 8 weeks | 
| Total Cholesterol Level | Lipid panel will be assessed. | Up to 8 weeks | 
| Triglyceride Level | Lipid panel will be assessed. | Up to 8 weeks | 
| C-reactive protein (CRP) Level | CRP will be measured as an inflammatory marker. | Up to 8 weeks | 
| Interleukin 6 (IL-6) | IL-6 will be measured as an inflammatory marker. | Up to 8 weeks | 
| Tumor necrosis factor alpha (TNF-alpha) | TNF-alpha will be measured as an inflammatory marker. | Up to 8 weeks | 
| Total daily energy expenditure | Energy expenditure will be measured using doubly-labeled water over 14 days | Baseline and endpoint (8 weeks) | 
| Energy Intake | Energy intake will be measured to assess diet quality using daily food records for 7 days. | Baseline and endpoint (8 weeks) | 
| Total Ghrelin | Total ghrelin will be assessed using radioimmunoassay (RIA). | 2 hours post meal at baseline and endpoint (8 weeks) | 
| Serum Leptin | Serum leptin will be measured using a double-antibody RIA. | 2 hours post meal at baseline and endpoint (8 weeks) | 
| Adiponectin Level | Adiponectin levels will be analyzed using RIA. | Up to 8 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 (8 weeks) | 
| Change in Nuclear factor kappa B (NFkB) Level | NFkB will be measured to assess endothelial cell inflammation. | Baseline and endpoint (8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Circadian Rhythms, Cardiometabolic Health