Impact of Yo-Yo Sleep on Cardiometabolic Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intermittent Short Sleep (ISS), Social Jetlag (SJL), Sustained Adequate Sleep (SAS).
- Who it may be relevant to
- Registry conditions: Cardiometabolic Syndrome, Obesity. Basic parameters: 18 years — 49 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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. - Behavioral Social Jetlag (SJL)
2-hour delayed sleep timing. - Behavioral Sustained Adequate Sleep (SAS)
Goal of ≥7 hours of sleep/night with 8 hours of time in bed (TIB).
Primary outcome measures
- Fasting Plasma Glucose [Time frame: Up to 4 weeks]
- Insulin Level [Time frame: Up to 4 weeks]
- Morning Systolic and Diastolic Blood Pressure [Time frame: Up to 4 weeks]
- Evening Systolic and Diastolic Blood Pressure [Time frame: Up to 4 weeks]
- Fat mass [Time frame: Up to 4 weeks]
Secondary outcome measures (12)
- Low-density Lipoprotein (LDL) Level [Time frame: Up to 4 weeks]
- High-density Lipoprotein (HDL) Level [Time frame: Up to 4 weeks]
- Total Cholesterol Level [Time frame: Up to 4 weeks]
- Triglyceride Level [Time frame: Up to 4 weeks]
- C-reactive protein (CRP) Level [Time frame: Up to 4 weeks]
- Interleukin 6 (IL-6) [Time frame: Up to 4 weeks]
- Tumor necrosis factor alpha (TNF-alpha) [Time frame: Up to 4 weeks]
- Total daily energy expenditure [Time frame: Baseline and endpoint (4 weeks)]
- Energy Intake [Time frame: Baseline and endpoint (4 weeks)]
- Total Ghrelin [Time frame: 2 hours post meal at baseline and endpoint (4 weeks)]
- Serum Leptin [Time frame: 2 hours post meal at baseline and endpoint (4 weeks)]
- Adiponectin Level [Time frame: Up to 4 weeks]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Columbia University Irving Medical Center — New York
Identifiers
NCT: NCT05880758 · AAAU3694 · R35HL155670