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Sleep Extension for Improved Health in Adolescents (SUNRISE Trial)

N/A

Waitlist Available

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

Must not have

Regular use of melatonin or other sleep aids

A prior diagnosis of a sleep disorder (e.g. insomnia, delayed sleep phase syndrome, obstructive sleep apnea)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week after baseline and 6 weeks after baseline

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in the late stages of puberty.

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My BMI is within the healthy range for my age and sex.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I regularly use melatonin or other sleep aids.

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I have been diagnosed with a sleep disorder like insomnia or sleep apnea.

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I have type 2 diabetes or prediabetes.

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I do not have a severe mental illness or an IQ below 70 that affects my sleep or decision-making.

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I am a teen not attending a traditional high school.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, 1 week after baseline and 6 weeks after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Dietary Intake

Change in Insulin Sensitivity

Change in Physical activity

+1 more

Secondary study objectives

Change in glycemic variability

MTNR1B rs10830963 SNP

Awards & 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: 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

0 / 7Eligibility criteria met