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Sleep Extension for Improved Health in Adolescents (SUNRISE Trial)
N/A
Recruiting
Led By Stacey Simon, PhD
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
Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.
BMI 5th-84th percentile for age and sex
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week after baseline and 6 weeks after baseline
Awards & highlights
SUNRISE Trial Summary
This trial plans to study how sleep may play a role in conditions like obesity and diabetes in teenagers.
Who is the study for?
This trial is for high school students aged 14-19 who sleep less than 7 hours on school nights, are not very active (less than 3 hours of exercise per week), and have a BMI within the normal range for their age and sex. They should be in later stages of puberty but can't join if they have sleep disorders, use sleep aids regularly, or take medications affecting insulin resistance or sleep.Check my eligibility
What is being tested?
The study investigates how extra sleep affects teenagers' sensitivity to insulin and eating habits. Participants will follow their usual sleeping routine for one week and then extend their bedtime by over an hour each night for another week. Researchers will measure changes in insulin response and dietary intake during these periods.See study design
What are the potential side effects?
Since this trial involves extending participants' amount of sleep without medication, there are no direct side effects from interventions like drugs. However, changing sleep patterns could temporarily affect mood, alertness, or daytime functioning.
SUNRISE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am in the late stages of puberty.
Select...
My BMI is within the healthy range for my age and sex.
SUNRISE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, 1 week after baseline and 6 weeks after baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 1 week after baseline and 6 weeks after baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Dietary Intake
Change in Insulin Sensitivity
Change in Physical activity
+1 moreSecondary outcome measures
Change in glycemic variability
MTNR1B rs10830963 SNP
SUNRISE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sleep ExtensionExperimental Treatment1 Intervention
Participants will be prescribed a sleep schedule that allows them to obtain 1 hour more time in bed compared to Typical Sleep. For participants completing the study September 2021 and later, they will also be instructed to take exogenous melatonin (500mcg) and maintain dim light conditions 2 hours before bedtime, and use light glasses for 30 minutes in an upright position after waking in the morning (Sleep Extension + Circadian Manipulation).
Group II: Typical SleepActive Control1 Intervention
All participants will sleep for 6 nights (Sunday - Thursday) in the home environment per their usual school schedule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Extension
2017
N/A
~400
Find a Location
Who is running the clinical trial?
University of Colorado, DenverLead Sponsor
1,738 Previous Clinical Trials
2,149,451 Total Patients Enrolled
5 Trials studying Sleep
133 Patients Enrolled for Sleep
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,314,517 Total Patients Enrolled
1 Trials studying Sleep
1,645 Patients Enrolled for Sleep
Stacey Simon, PhDPrincipal InvestigatorChildren's Hospital Colorado and University of Colorado Anschutz Medical Campus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You usually sleep less than 7 hours on school nights.I regularly use melatonin or other sleep aids.I am not taking medications that affect insulin resistance or sleep.I have been diagnosed with a sleep disorder like insomnia or sleep apnea.I have type 2 diabetes or prediabetes.I do not have a severe mental illness or an IQ below 70 that affects my sleep or decision-making.I am a high school student aged between 14 and 19.I am in the late stages of puberty.You don't do regular physical activity for at least 3 hours per week.I am a teen not attending a traditional high school.My BMI is within the healthy range for my age and sex.
Research Study Groups:
This trial has the following groups:- Group 1: Typical Sleep
- Group 2: Sleep Extension
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 recruitment for this clinical experiment still available?
"Yes, the clinical trial is currently searching for qualified participants. According to information on clinicaltrials.gov, it was first posted in October 15th 2018 and recently updated on August 31st 2022. 75 patients are being recruited from a single medical site."
Answered by AI
How many volunteers have enrolled in this medical research experiment?
"Affirmative. Clinicaltrials.gov displays information that indicates the ongoing recruitment of participants for this trial, which was initially posted on October 15th 2018 and last updated on August 31st 2022. 75 patients are being sought from one medical centre."
Answered by AI
Does this research include participants who have surpassed their eightieth birthday?
"The study is open to participants aged between 14 and 19 years of age."
Answered by AI
Which demographic is eligible to participate in this research?
"This experiment is accepting 75 teenagers, aged 14 to 19, who suffer from poor sleeping habits and a sedentary lifestyle (fewer than 3 hours of exercise per week). In addition, their BMI must be between the 5th-84th percentile for age and sex. Also, they have to have reached Tanner stage 4 or 5 based on sexual maturity assessment. Ultimately, participants are required to sleep fewer than 7 hours each night during school days."
Answered by AI
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