Sleep Extension for Improved Health in Adolescents

(SUNRISE Trial)

Overseen By Stacey Simon, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Metformin, Stimulants, Antipsychotics, Steroids

Disqualifiers: Sleep disorders, Diabetes, Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how sleep affects health in teenagers, focusing on insulin resistance (when insulin doesn't work as well) and its link to sleep. By comparing teens' usual sleep patterns with a week where they get an extra hour in bed, researchers aim to determine if more sleep can influence factors like weight gain and diabetes. This approach, known as Sleep Extension or Sleep Therapy, involves extending sleep duration to improve health outcomes. Teens who usually sleep less than 7 hours on school nights might be suitable candidates. Participants will also try using melatonin and light adjustments to assess their effectiveness. As an unphased trial, this study offers a unique opportunity to contribute to understanding the impact of sleep on teen health.

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.

What prior data suggests that this sleep intervention is safe for adolescents?

Research has shown that sleep extension treatments are generally safe for teenagers. Studies have found that methods to help teenagers sleep longer can increase sleep time without causing major side effects. Participants usually tolerate these methods well, experiencing few negative effects.

In some studies, teenagers who participated in sleep extension trials reported feeling better and more rested. This suggests that getting more sleep can safely improve health, such as reducing the risk of weight gain and insulin-related issues.

Overall, the research supports the safety of sleep extension methods, making them a promising way to enhance sleep and health in teenagers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep Extension treatment for adolescents because it explores enhancing sleep as a method to improve overall health, which is different from typical lifestyle advice like maintaining a regular sleep schedule. This approach is unique as it not only extends sleep duration but also includes circadian manipulation using exogenous melatonin and light therapy. These elements aim to optimize the sleep-wake cycle, potentially offering benefits beyond what standard sleep hygiene practices can achieve. By combining these strategies, the treatment has the potential to address sleep issues more effectively, leading to better health outcomes for adolescents.

What evidence suggests that sleep extension might be an effective treatment for insulin resistance in teenagers?

Research has shown that getting more sleep benefits health, especially for young individuals. In this trial, participants in the Sleep Extension arm will follow a prescribed sleep schedule that provides 1 hour more time in bed compared to the Typical Sleep arm. Studies have found that extending sleep duration in children and teens effectively increases both sleep quantity and quality. Additionally, more sleep can reduce daytime sleepiness. Overall, evidence suggests that increased sleep can improve health in various ways, such as aiding insulin resistance and preventing weight gain. ^{6 7 8 9 10}

Who Is on the Research Team?

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.

Exclusion Criteria

I regularly use melatonin or other sleep aids.

Schedules that would preclude participants from adhering to the sleep manipulation (e.g. night shift employment)

I am not taking medications that affect insulin resistance or sleep.

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?

Group I: Sleep Extension Experimental Treatment 1 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 Sleep Active Control 1 Intervention

All participants will sleep for 6 nights (Sunday - Thursday) in the home environment per their usual school schedule.

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

In a study of 54 adolescents with asthma, those who had only 6.5 hours of sleep per night experienced lower lung function and increased asthma symptoms compared to when they had 9.5 hours of sleep, highlighting the importance of adequate sleep for asthma management.

The findings suggest that insufficient sleep negatively affects both the physical symptoms of asthma and the overall quality of life for adolescents, indicating that improving sleep health should be a key focus in asthma treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of sleep opportunity on asthma outcomes in adolescents. Meltzer, LJ., Beebe, DW., Jump, S., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral interventions to extend sleep duration: A systematic review and meta-analysis. Baron, KG., Duffecy, J., Reutrakul, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11390171/

Sleep Hygiene Intervention Improves Sleep Time and ... Conclusion. The health promotion action positively affected sleep duration and sleep time on school days and contributed to the reduction in daytime sleepiness.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10476177/

Behavioral interventions to extend sleep duration The goal of this study was to examine the effects of behavioral sleep extension interventions on sleep duration outcomes in children and adults ≥ age 12.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1087079223000631

Interventions to increase sleep duration in young people The findings indicate that behavioral and combination interventions were consistently effective in increasing sleep duration in healthy young people.

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Effectiveness of sleep hygiene measures on sleep quality ... A quasi-experimental study was undertaken to assess the effectiveness of sleep hygiene measures on sleep quality of adolescents with mental ...

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Sleep in young people: What works now and where to? A ... Brief behavioral sleep intervention for adolescents: An effectiveness study brief individual sleep intervention can increase sleep duration ...

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A systematic review and meta-analysis of behavioral sleep ... The meta-analysis showed that behavioral sleep interventions improve total sleep time but have no significant effect on sleep efficiency.

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A cluster randomized controlled trial of a theory-based sleep ... The present research found that a theory-based intervention improved sleep outcomes among adolescents, as evidenced by improved sleep ...

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Nonpharmacological Interventions to Lengthen Sleep ... The primary outcome was change in mean self-reported, parent-reported, or objectively measured daily total sleep time (in minutes) in children ...

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Effects of Digital Sleep Interventions on Sleep Among ... These findings suggest that digital sleep interventions are likely to significantly improve sleep quality in both postintervention and follow-up ...