Sleep Promotion Program for Teenagers with Sleep Disorders

(SPP PC Trial)

Overseen By Paige DeGennaro

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Sleep apnea, Narcolepsy, Bipolar, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new Sleep Promotion Program aimed at helping teenagers with sleep issues and depression. The program includes two sessions with a clinician and uses smartphone technology to teach healthy sleep habits. Researchers aim to determine if this approach is more effective than a simple talk about sleep. Teenagers who may be suitable for the trial have depression, sleep less than 7 hours on school nights, or have significant differences in their sleep schedule between weekdays and weekends. As an unphased trial, this study provides a unique opportunity for teenagers to explore innovative solutions for better sleep and improved mental health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that participants should not have had changes in medications in the month before screening. This might mean that stable medication use is allowed.

What prior data suggests that the Sleep Promotion Program is safe for teenagers?

Research shows that sleep programs for young people are generally safe. The Sleep Promotion Program (SPP) under testing aims to help teenagers improve their sleep habits. It includes two personal sessions and online tools. This type of program is non-invasive, meaning it doesn't involve taking medicine or having surgery.

Similar programs have not reported serious side effects. These programs mainly focus on teaching better sleep habits, so they are usually well-tolerated. While specific safety data for the SPP is not yet available, similar sleep programs are considered safe. This trial primarily assesses the program's effectiveness and ease of use, suggesting that safety issues are not a major concern at this stage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep Promotion Program (SPP) because it offers a fresh approach to tackling sleep disorders in teenagers. Unlike traditional treatments that might focus on medication or long-term therapy, SPP is a short, intensive program that combines personalized sessions with a clinician and online resources, making it more accessible and flexible for teens. The use of telehealth or in-person options also caters to varying preferences and needs, potentially improving engagement and outcomes. Additionally, SPP is designed to equip teens with practical skills to improve their sleep, which could offer more sustainable benefits compared to other methods.

What evidence suggests that this trial's treatments could be effective for teenagers with sleep disorders?

This trial will compare the Sleep Promotion Program (SPP) with Sleep Psychoeducation (SPE) for teenagers with sleep disorders. Research has shown that behavior-changing programs can help young people sleep longer. One study found that these sleep programs helped teenagers sleep more and feel less tired during the day within a few weeks. Another study showed that these programs worked even better when combined with other methods. While some programs mainly teach about sleep, they still lead to small improvements in sleep. Overall, these programs seem promising for helping teenagers with sleep problems. ^{6 7 8 9 10}

Who Is on the Research Team?

Jessica C Levenson

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adolescents aged 12-18 who experience short sleep duration and irregular sleep-wake patterns, with symptoms of depression. The program aims to help them improve their sleep habits using smartphone technology and personal sessions.

Inclusion Criteria

I am over 18, a parent/guardian of a youth in the study, and spend 10+ hours weekly with them.

I am a minor and both I and my parent/guardian agree to participate.

Youth: Currently a patient at Kids Plus Pediatrics

Exclusion Criteria

I am young and have serious or uncontrolled health issues.

I am a young person diagnosed with a sleep disorder like sleep apnea or narcolepsy.

I am a young person needing urgent help for thoughts of harming myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Sleep Promotion Program (SPP) or Sleep Psychoeducation (SPE) over two individual sessions, approximately 2 weeks apart, with web-based intervention components.

4 weeks

2 visits (telehealth or in-person)

Follow-up

Participants are monitored for changes in sleep duration, sleep-wake regularity, and depressive symptoms.

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Promotion Program
• Sleep Psychoeducation

Trial Overview The study is testing a Sleep Promotion Program (SPP) that includes two individual sessions plus smart phone tech against just one session on healthy sleep habits. It's a small test run to see if the SPP can work in real life.

How Is the Trial Designed?

Group I: Sleep Promotion Program Experimental Treatment 1 Intervention

Participants will receive the Sleep Promotion Program (SPP), consisting of 2 individual sessions with a clinician via telehealth (or in-person if desired), about 2 weeks apart, and web-based intervention components.

Group II: Sleep Psychoeducation Active Control 1 Intervention

Participants will receive Sleep Psychoeducation (SPE), a 20-minute discussion with a clinician via telehealth (or in person).

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Sleep disorders affect about one-third of people and can lead to serious issues like depression and impaired performance in daily activities, especially during adolescence when conditions like delayed sleep phase syndrome (DSPS) become common.

Health professionals, including general practitioners and school nurses, need better training to identify and treat sleep disorders, as early recognition and appropriate referral to specialists can significantly improve outcomes for affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep disorders in general and in adolescence. Stores, G.[2015]

A pilot trial involving 58 adolescents (average age 14) showed that a sleep promotion program significantly improved overall sleep quality, sleep onset latency, sleep duration, and reduced daytime sleepiness compared to a control group.

While the program demonstrated positive effects on sleep behaviors, it did not significantly impact sleep hygiene or other sleep parameters, indicating the need for further research to confirm its efficacy in a larger sample.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Promotion Program for Improving Sleep Behaviors in Adolescents: A Randomized Controlled Pilot Study. John, B., Bellipady, SS., Bhat, SU.[2020]

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]

Adolescents generally need more sleep than they are getting, with many experiencing decreased total sleep time and increased daytime sleepiness due to factors like puberty, school schedules, and part-time jobs.

Chronic insufficient sleep in teenagers can lead to serious consequences, including mood and behavior problems, increased risk of accidents, and vulnerability to substance abuse, highlighting the need for educational programs on proper sleep hygiene.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of sleep and sleepiness in adolescents. Carskadon, MA.[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]

Delayed sleep phase disorder (DSPD) is prevalent in adolescents and can lead to significant negative effects on academic performance, making accurate diagnosis crucial for effective treatment.

Treatment options for DSPD include bright light therapy, chronotherapy, and melatonin, which help regulate sleep patterns without acting as sedatives, alongside addressing lifestyle factors for improved sleep and mood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian rhythm disorders among adolescents: assessment and treatment options. Bartlett, DJ., Biggs, SN., Armstrong, SM.[2019]

The interactive school-based sleep education program (SEP) improved students' knowledge about sleep compared to a healthy living program, indicating that education can raise awareness about the importance of sleep.

Despite increased knowledge and intentions to prioritize sleep, the SEP did not lead to actual changes in sleep duration, suggesting that additional strategies, such as adjusting school start times and involving parents, may be necessary to effectively improve adolescent sleep habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an interactive school-based sleep education program: a cluster-randomized controlled trial. van Rijn, E., Koh, SYJ., Ng, ASC., et al.[2020]

In a long-term follow-up study of 10 adolescents with sleep-wake schedule disorders, 3 patients fully remitted and 6 showed improvement in their illness severity, indicating that intensive treatment can lead to positive outcomes over time.

All participants demonstrated enhanced social adaptation, suggesting that improvements in social functioning may be more pronounced than changes in the severity of the sleep disorders themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up study of 10 adolescent patients with sleep-wake schedule disorders. Ando, K., Hayakawa, T., Ohta, T., et al.[2019]

Chronic sleep disruption in children and adolescents negatively impacts cognitive functioning, highlighting the importance of addressing sleep issues early.

Behavioral interventions, such as graduated extinction and positive bedtime routines, have been shown to significantly improve sleep problems in young children, making them effective nonpharmacological treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment and treatment of common pediatric sleep disorders. Moturi, S., Avis, K.[2021]

School-based sleep promotion programs have the potential to significantly improve sleep knowledge, hygiene, quality, behavior, and efficiency among adolescents, who typically need 8 to 10 hours of sleep but often get less due to various pressures.

This systematic review will analyze studies involving adolescents aged 10-19, using rigorous methods to assess the effectiveness of these programs, which could lead to better sleep health and reduced risks of related issues like stress and cardiovascular problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of school-based sleep promotion programs for adolescents: a systematic review protocol. Duque, FM., Santos, D., Pinto, D., et al.[2023]

Involving stakeholders such as young adults, parents, and healthcare providers in the development of sleep promotion programs for adolescents is essential for creating effective and acceptable interventions, as highlighted by feedback from 9 focus groups with 49 participants.

Strategies to improve adolescent sleep should focus on enhancing internal motivation, personalizing content, and encouraging parents to model good sleep behaviors, which can help sustain behavior change and make programs more feasible and scalable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing adolescent sleep interventions with stakeholder input. Levenson, JC., Ford, HA., Reyes, ZMD., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7790452/

The Teensleep study: the effectiveness of a school-based ... Teensleep was effective at improving sleep knowledge but sleep changes were small. Such interventions have traditionally focused on gains for all students.

2. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11456

a pilot feasibility randomized controlled trial Of the participants 35%–47% reported they did not have concerns related to the youth's sleep at the start of the program, even though youth met our sleep ...

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.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/92/NCT06306092/Prot_SAP_000.pdf

Promoting teenage sleep for improved mental health and ... The overall aim of this project is to evaluate the effectiveness of two school-based programs that have the potential to promote adolescent ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2016/8013431

Sleep Promotion Program for Improving Sleep Behaviors in ... The study also showed a positive effect on adolescent's sleep duration at 2 weeks and daytime sleepiness at 6 weeks. A few studies had also ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5882235/

Effects of the Young Adolescent Sleep Smart Program on ... The aim of the Sleep Smart Program was to primarily improve sleep health behaviors and secondarily improve academic performance and behavioral well-being.

7. odphp.health.gov odphp.health.gov/healthypeople/objectives-and-data/browse-objectives/sleep

Sleep - Healthy People 2030 | odphp.health.gov Healthy People 2030 includes objectives focused on helping people get enough sleep, treating sleep disorders, and decreasing drowsy driving.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7024093/

Disparities in Sleep Health among Adolescents: The Role of ... The prevalence of sleep problems was age dependent, with 65% of the preadolescents reporting less than the recommended sleep time. An additional ...

9. archive.cdc.gov archive.cdc.gov/www_cdc_gov/healthyschools/sleep.htm

Sleep and Health | Healthy Schools Children and adolescents who do not get enough sleep have a higher risk for many health problems, including obesity, type 2 diabetes, poor mental health, and ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S1470211824013472

Reviews Sleep in adolescents and young adults This review article looks at why sleep matters within this population group, how it can impact on longer term health consequences and discusses some tools to ...