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Impact of Yo-Yo Sleep on Cardiometabolic Health
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).
Conditions:
🦠 Cardiometabolic Syndrome 🦠 Obesity
🗓️ Study Start (Actual) 22 September 2023
🗓️ Primary Completion (Estimated) December 2027
✅ Study Completion (Estimated) June 2028
👥 Enrollment (Estimated) 72
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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: 18 Years to 49 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 May 2023
  • First Submitted that Met QC Criteria 25 May 2023
  • First Posted 30 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 March 2024
  • Last Update Posted 25 March 2024
  • Last Verified March 2024
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