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

75 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

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. ^{1 2 3 4 8}

Research Team

Stacey Simon, PhD

Principal Investigator

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

Eligibility Criteria

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

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Behavioral interventions to extend sleep duration: A systematic review and meta-analysis. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The effects of sleep extension on sleep and cognitive performance in adolescents with chronic sleep reduction: an experimental study. [2015]

3. England pubmed.ncbi.nlm.nih.gov

The feasibility of at-home sleep extension in adolescents and young adults: A meta-analysis and systematic review. [2022]

4. England 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. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Interventions to increase sleep duration in young people: A systematic review. [2023]

6. England 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. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Impact of sleep opportunity on asthma outcomes in adolescents. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Preventing sleep deficit in adolescents: Long-term effects of a quasi-experimental school-based intervention study. [2021]