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Behavioral Intervention
Sleep Extension for Insulin Resistance (REM Trial)
N/A
Waitlist Available
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
REM Trial Summary
This trial will test a 4-week sleep extension intervention on adolescents to see if it's feasible and to get preliminary data on how it affects their metabolism.
Who is the study for?
This trial is for high school students aged 13-19 with prediabetes (HbA1c between 5.7-6.4%), who are in the later stages of puberty and have a BMI above the 85th percentile for their age and sex. It's not suitable for those on certain medications, with severe mental illness, diagnosed sleep disorders, or schedules that conflict with the sleep extension protocol.Check my eligibility
What is being tested?
The study tests whether extending sleep duration over four weeks can improve insulin resistance and energy metabolism in adolescents. Participants will follow a specific sleep schedule designed to increase their usual amount of sleep.See study design
What are the potential side effects?
Since this intervention involves only extending natural sleep patterns without medication, side effects are minimal but may include changes in daytime alertness or mood due to alterations in sleeping habits.
REM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Total Sleep Time
REM Trial Design
1Treatment groups
Experimental Treatment
Group I: Extended Sleep Intervention (ES)Experimental Treatment1 Intervention
Participants will receive a Standard Care Diet and Physical Activity Education Intervention (SC) and an Extended Sleep Intervention (ES). For the SC, participants will have their diet, physical activity, and screen time assessed by study interventionist. Prescribed goals will be determined collaboratively through discussion with participants and parents. For the ES, participants will subsequently be prescribed a sleep schedule that allows them to obtain 1.5 h more time in bed compared to their typical sleep. Prescribed bedtimes and wake times will be determined collaboratively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Extended Sleep Intervention
2019
N/A
~10
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Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,732 Previous Clinical Trials
2,143,538 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have traveled across more than two time zones in the two weeks before the study.You have a certain level of HbA1c that shows you are at risk for developing diabetes.You are currently taking certain medications that affect insulin resistance or sleep.You have a severe mental illness like schizophrenia or very low IQ that may affect your sleep or understanding of the study.You have type 2 diabetes with high HbA1c levels.You have been diagnosed with a sleep disorder, such as insomnia or sleep apnea, or have abnormal test results for sleep disorders.Teens who are not attending a regular high school program, such as those who are home-schooled.Your work schedule doesn't allow you to follow the sleep extension plan, like if you work at night.Girls with developed breasts or boys with enlarged testicles are not eligible.Your body mass index (BMI) is higher than what is considered healthy for your age and gender.You regularly take melatonin or other medications to help you sleep.
Research Study Groups:
This trial has the following groups:- Group 1: Extended Sleep Intervention (ES)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age limit for enrollees in this trial constrained by any particular cutoff?
"This experiment is open to minors aged 13 and above, up until they turn 19."
Answered by AI
Could you provide the aggregate number of participants enrolled in this experiment?
"Affirmative. Evidence on clinicaltrials.gov reveals that this medical investigation, which was first published in March of 2019 is still searching for participants. 26 enrollees are necessary from one single location."
Answered by AI
Are there any available openings for volunteers in this experiment?
"As per the information posted on clinicaltrials.gov, this research trial is still open for participants to join. It was initially listed on March 21st 2019 and recently updated on March 8th 2021."
Answered by AI
May I apply to participate in this research program?
"A total of 26 adolescents aged 13 to 19, diagnosed with type 2 diabetes mellitus and exhibiting a body mass index above the 85th percentile for their age and gender, as well as Tanner Stage 4-5 (based on secondary sex characteristics), are being enrolled in this clinical trial."
Answered by AI
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