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Behavioral Intervention
Sleep Extension for Obesity
N/A
Recruiting
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: 18-45 years old; equal numbers of men and women
Be between 18 and 65 years old
Must not have
Clinically diagnosed sleep disorder or major psychiatric illness
Clinically diagnosed diabetes or fasting plasma glucose ≥126 mg/dL or HbA1c ≥6.5%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the baseline ambulatory assessment and weeks 2, 4, 6, and 8 of the intervention ambulatory assessment.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to find out how increasing the amount of time spent in bed can affect the levels of certain substances in the blood and how well the body responds to insulin. Participants will be randomly assigned to
Who is the study for?
This trial is for people who are overweight or obese, sleep less than 6.5 hours a night, and may have issues with insulin sensitivity. It's not suitable for individuals with certain allergies, eating disorders, or other conditions that could interfere with the study.
What is being tested?
The study tests if sleeping more (2 extra hours per night) can change blood levels of ceramides (fats) and improve how the body uses insulin compared to just getting healthy lifestyle advice without added sleep.
What are the potential side effects?
Since this trial involves non-medical interventions like increasing sleep duration and providing health information, significant side effects are not expected. However, changes in sleep patterns can sometimes affect mood and alertness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with a sleep disorder or major psychiatric illness.
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I have diabetes or my blood sugar/HbA1c levels are high.
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I do not have major heart or kidney disease.
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I am not taking medications that affect sleep, sugar levels, or blood thinning.
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I am currently pregnant, nursing, going through menopause, or am post-menopausal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ analyzed as change from baseline for each week of the ~8 week experimental segment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~analyzed as change from baseline for each week of the ~8 week experimental segment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Insulin Sensitivity
Total Plasma Ceramides
Secondary study objectives
Average (per week) daytime alertness change from baseline
Average (per week) nightly total sleep time (change from baseline)
Average (per week) sleep satisfaction change from baseline
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention GroupExperimental Treatment1 Intervention
Sleep extension-based intervention focused on increasing time in bed by 2 hours per night.
Group II: Control GroupActive Control1 Intervention
Provided with general health information on diet and physical activity.
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Who is running the clinical trial?
University of UtahLead Sponsor
1,141 Previous Clinical Trials
1,697,729 Total Patients Enrolled
1 Trials studying Sleep Hygiene
20 Patients Enrolled for Sleep Hygiene
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