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Varied Sleep Patterns for Cardiometabolic Health

N/A
Recruiting
Led By Marie-Pierre St-Onge, PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Habitually sleeping 7-9 hours/night without sleep aids or naps
Aged 18 to 49 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours post meal at baseline and endpoint (4 weeks)
Awards & highlights

Study Summary

This trial tests the effects of repeated short sleep and delayed sleep midpoint on energy balance and heart health in young to middle-aged adults.

Who is the study for?
This trial is for adults aged 18-49 with a BMI of 20-29.9 who usually sleep 7-9 hours without aids or naps. It's not for those who've recently changed weight, are in weight loss programs, have had bariatric surgery, smoke, have sleep disorders, take certain blood medications, have psychiatric conditions including eating disorders and seasonal affective disorder, are pregnant or breastfeeding, have high blood pressure on beta-blockers or diabetes.Check my eligibility
What is being tested?
The study compares the effects of intermittent short sleep (5 days of less sleep followed by 2 days of more) to consistent adequate nightly sleep on heart health and metabolism over an eight-week period. It also examines if keeping a constant midpoint of sleep during short nights affects outcomes differently than shifting it later.See study design
What are the potential side effects?
While this trial does not involve medication that typically has side effects like drugs do, participants may experience fatigue or stress due to altered sleeping patterns which could potentially impact mood and alertness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I usually sleep 7-9 hours a night without needing sleeping pills or naps.
Select...
I am between 18 and 49 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours post meal at baseline and endpoint (4 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours post meal at baseline and endpoint (4 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evening Systolic and Diastolic Blood Pressure
Fasting Plasma Glucose
Fat mass
+2 more
Secondary outcome measures
Adiponectin Level
C-reactive protein (CRP) Level
Change in Nuclear factor kappa B (NFkB) Level
+11 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: ISS_SJLExperimental Treatment2 Interventions
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
Group II: ISS_AloneExperimental Treatment1 Intervention
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
Group III: Stable Adequate Sleep (SAS)Active Control1 Intervention
Participants will go to bed and wake up at the same time every night, maintaining adequate sleep duration.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,426 Previous Clinical Trials
2,473,736 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
853 Previous Clinical Trials
535,861 Total Patients Enrolled
University of Colorado, DenverOTHER
1,729 Previous Clinical Trials
2,143,620 Total Patients Enrolled

Media Library

Intermittent Short Sleep (ISS) Clinical Trial Eligibility Overview. Trial Name: NCT05880758 — N/A
Cardiometabolic Syndrome Research Study Groups: ISS_SJL, ISS_Alone, Stable Adequate Sleep (SAS)
Cardiometabolic Syndrome Clinical Trial 2023: Intermittent Short Sleep (ISS) Highlights & Side Effects. Trial Name: NCT05880758 — N/A
Intermittent Short Sleep (ISS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05880758 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age of 55 or older render an individual ineligible for this testing?

"Only those over 18 and younger than 49 are eligible for recruitment in this trial."

Answered by AI

Could I possibly qualify for this research trial?

"Eligibility for this trial necessitates cardiometabolic syndrome and a participant's age to be between 18-49. A total of 72 patients are being accepted into the program."

Answered by AI

Are there still spots available to join this clinical trial?

"Affirmative. Per the clinicaltrials.gov website, this medical trial is currently recruiting patients with a start date of June 1st 2023 and last update on May 25th 2023. In total, 72 individuals are needed to participate at one site."

Answered by AI

What is the ultimate aim of this experiment?

"The primary aim of this experiment, assessed after up to 8 weeks is a change in insulin levels. Secondary objectives include assessing the High-density Lipoprotein (HDL) Level, Total Cholesterol Level and Triglyceride Levels with a lipid panel test."

Answered by AI

What is the current enrollment for this investigation?

"Affirmative. According to the clinicaltrials.gov, this trial is actively looking for suitable participants and was initially posted on June 1st 2023 with most recent edits occurring on May 25th 2023. The study requests 72 enrollees from a single site."

Answered by AI
~48 spots leftby Dec 2027