Impact of Yo-Yo Sleep on Cardiometabolic Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-49
SponsorColumbia University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 18 to 49 years
BMI 20-29.9 kg/m2
Habitually sleeping 7-9 hours/night without sleep aids or naps
Disqualifiers
Sleep disorders
Psychiatric disorders (including eating disorders) and seasonal affective disorder
Pregnancy (current/prior year)
Breastfeeding
Trial design
Design model
Parallel
Treatments tested in this trial
Intermittent Short Sleep (ISS)
BehavioralRestricted 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.
Social Jetlag (SJL)
Behavioral2-hour delayed sleep timing.
Sustained Adequate Sleep (SAS)
BehavioralGoal of ≥7 hours of sleep/night with 8 hours of time in bed (TIB).
Treatment groups
72 Participants
are divided into 3 treatment groupsGroup A: Stable Adequate Sleep (SAS)Active comparator 1 intervention
Group B: ISS_AloneExperimental treatment 1 intervention
Group C: ISS_SJLExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Fasting Plasma Glucose
Insulin resistance will be assessed by measuring fasting plasma glucose levels.
Time frame
Up to 4 weeks2
Insulin Level
Insulin resistance will be assessed by measuring insulin levels.
Time frame
Up to 4 weeks3
Morning Systolic and Diastolic Blood Pressure
Ambulatory blood pressure will be measured.
Time frame
Up to 4 weeks4
Evening Systolic and Diastolic Blood Pressure
Ambulatory blood pressure will be measured.
Time frame
Up to 4 weeksSecondary outcomes
1
Low-density Lipoprotein (LDL) Level
Lipid panel will be assessed.
Time frame
Up to 4 weeks2
High-density Lipoprotein (HDL) Level
Lipid panel will be assessed.
Time frame
Up to 4 weeks3
Total Cholesterol Level
Lipid panel will be assessed.
Time frame
Up to 4 weeks4
Triglyceride Level
Lipid panel will be assessed.
Time frame
Up to 4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborator
University of Colorado, Denver
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov