75 Participants Needed

Sleep Extension for Improved Health in Adolescents

(SUNRISE Trial)

SS
Overseen ByStacey Simon, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Many teenagers do not get enough sleep. Obesity and diabetes are increasing in teenagers as well. This study plans to learn more about sleep and insulin resistance (insulin not working) in teenagers, and how these things may be related depending on sleep. This is important to know so that the investigators understand how sleep may play a role in health conditions like extra weight gain (increased food intake and less physical activity) and diabetes. To answer this question, the investigators plan to enroll teenagers who get \<7 hours of sleep on school nights and measure changes in insulin sensitivity and dietary intake after a week of typical sleep (sleeping on their normal school schedule) and a week of longer sleep (spending 1+ hour longer in bed each night).

Will I have to stop taking my current medications?

If you are taking medications that affect insulin resistance or sleep, such as metformin, stimulants, atypical antipsychotics, or oral steroids, you will need to stop taking them to participate in the trial. Regular use of melatonin or other sleep aids is also not allowed.

Is sleep extension safe for adolescents?

Research on sleep extension and related interventions like sleep hygiene and education shows they are generally safe for adolescents. These approaches focus on improving sleep habits and have not been associated with any significant safety concerns.12345

How does the treatment Sleep Extension differ from other treatments for sleep problems in adolescents?

Sleep Extension is unique because it focuses on gradually increasing sleep duration and improving sleep habits (like bedtime routines) to enhance sleep quality and reduce daytime sleepiness, rather than using medication or other direct interventions. This approach is particularly novel for adolescents, as it combines practical sleep hygiene advice with a focus on extending sleep time at home.23467

What data supports the effectiveness of the treatment Sleep Extension, Sleep Therapy, Sleep Hygiene, Sleep Intervention for improving health in adolescents?

Research shows that extending sleep duration through behavioral interventions can significantly improve sleep quality and reduce daytime sleepiness in adolescents. Combining sleep extension with sleep hygiene advice has also been found to improve sleep and reduce depressive symptoms in this age group.23468

Who Is on the Research Team?

SS

Stacey Simon, PhD

Principal Investigator

Children's Hospital Colorado and University of Colorado Anschutz Medical Campus

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You usually sleep less than 7 hours on school nights.
I am a high school student aged between 14 and 19.
I am in the late stages of puberty.
See 2 more

Exclusion Criteria

Schedules that would preclude participants from adhering to the sleep manipulation (e.g. night shift employment)
I regularly use melatonin or other sleep aids.
I am not taking medications that affect insulin resistance or sleep.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Typical Sleep

Participants sleep for 6 nights on their usual school schedule in the home environment

1 week
Home environment

Sleep Extension

Participants follow a prescribed sleep schedule with 1 hour more time in bed, with additional circadian manipulation for some participants

1 week
Home environment

Follow-up

Participants are monitored for changes in insulin sensitivity, physical activity, sleep duration, and dietary intake

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sleep Extension
Trial Overview 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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Published Research Related to This Trial

Behavioral sleep extension interventions significantly increase sleep duration in both children and adults aged 12 and older, with a pooled effect size indicating substantial improvement compared to control groups.
Direct interventions that specify sleep schedules are more effective than indirect methods like coaching, suggesting that clearer and more structured approaches to sleep extension yield better results.
Behavioral interventions to extend sleep duration: A systematic review and meta-analysis.Baron, KG., Duffecy, J., Reutrakul, S., et al.[2023]
A study involving 55 adolescents with chronic sleep reduction showed that gradual sleep extension, combined with sleep hygiene advice, significantly improved sleep duration and quality, leading to earlier bedtimes and reduced insomnia symptoms.
Participants in the sleep extension group also experienced a notable decrease in depressive symptoms, suggesting that improving sleep can positively impact mood in adolescents.
The effects of sleep extension and sleep hygiene advice on sleep and depressive symptoms in adolescents: a randomized controlled trial.Dewald-Kaufmann, JF., Oort, FJ., Meijer, AM.[2015]
A sleep education program for adolescents significantly improved their knowledge of sleep health and promoted better sleep behaviors, as evidenced by substantial increases in sleep-related knowledge and practices after the intervention.
The program also led to notable improvements in sleeping patterns, including earlier bedtimes, reduced sleep-onset latency, increased total sleep time, and decreased daytime sleepiness, compared to a waiting-list control group of 243 students from 5 junior high schools.
Effects of a sleep education program with self-help treatment on sleeping patterns and daytime sleepiness in Japanese adolescents: A cluster randomized trial.Tamura, N., Tanaka, H.[2022]

Citations

Behavioral interventions to extend sleep duration: A systematic review and meta-analysis. [2023]
The effects of sleep extension on sleep and cognitive performance in adolescents with chronic sleep reduction: an experimental study. [2015]
The feasibility of at-home sleep extension in adolescents and young adults: A meta-analysis and systematic review. [2022]
The effects of sleep extension and sleep hygiene advice on sleep and depressive symptoms in adolescents: a randomized controlled trial. [2015]
Interventions to increase sleep duration in young people: A systematic review. [2023]
Effects of a sleep education program with self-help treatment on sleeping patterns and daytime sleepiness in Japanese adolescents: A cluster randomized trial. [2022]
Impact of sleep opportunity on asthma outcomes in adolescents. [2022]
Preventing sleep deficit in adolescents: Long-term effects of a quasi-experimental school-based intervention study. [2021]
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