Sleep Promotion Program for Sleep Deprivation

(SPP OT 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new Sleep Promotion Program designed to help teens with sleep problems and depression. The program includes one-on-one sessions with a clinician and smartphone tools to teach better sleep habits. Teens aged 12-18 who are patients at Kids Plus Pediatrics, have depression, and get less than 7 hours of sleep on school nights or have significant differences in their sleep schedule between weekdays and weekends might be a good fit. The trial aims to refine the program based on feedback to enhance its effectiveness and user-friendliness.

As an unphased trial, this study offers teens a unique opportunity to contribute to developing a potentially impactful program tailored to their needs.

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 this Sleep Promotion Program is safe for adolescents?

Research has shown that programs like the Sleep Promotion Program (SPP) are generally safe. These programs aim to improve sleep habits without medication. For instance, one program helped many people sleep better without major problems.

In this trial, the Sleep Promotion Program uses technology and short sessions with a clinician to help teenagers sleep better. It focuses on increasing sleep time and regularizing sleep patterns. Because it uses behavioral methods, it is expected to be well-tolerated. Similar programs have not reported significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Sleep Promotion Program because it offers a personalized approach to tackling sleep deprivation, which is different from common treatments like medication or sleep hygiene education. This program involves two individual sessions with a clinician, providing tailored guidance via telehealth or in-person, along with web-based resources. This interactive and flexible format allows for a more accessible and potentially more effective way to improve sleep compared to traditional methods.

What evidence suggests that the Sleep Promotion Program is effective for sleep deprivation?

Research has shown that programs like the Sleep Promotion Program, which participants in this trial will receive, can help young people sleep more. One study found that these programs consistently increase sleep duration in young people. Another study showed that as sleep problems decreased, depression scores also went down, indicating better mental health. These findings suggest that targeted sleep programs can improve sleep habits and overall well-being. ^{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 who are experiencing sleep problems like insufficient sleep or irregular sleep patterns. Participants will be involved in refining the program based on their feedback.

Inclusion Criteria

Youth: Currently a patient at Kids Plus Pediatrics

I am currently experiencing depression.

I sleep less than 7 hours on school nights or my sleep schedule changes by 2 or more hours on weekends.

Exclusion Criteria

I am currently experiencing thoughts of harming myself and need immediate help.

Parents: Have any physical or mental condition that would preclude study participation

I am a young person with serious or uncontrolled health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

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

4 weeks

2 visits (telehealth or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Promotion Program

Trial Overview The Sleep Promotion Program (SPP) being tested involves one individual session and uses smartphone technology to help teens improve their sleep. This open trial aims to refine the program with participant and staff input.

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.

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

A study involving nursing interventions to promote sleep quality in hospitalized patients showed that the intervention group reported better sleep, particularly among men, highlighting the potential effectiveness of targeted sleep support.

The findings suggest that pain intensity is linked to sleep quality, and emphasize the need for individualized sleep care plans and training for nurses to enhance patients' sleep during hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep improvement intervention and its effect on patients' sleep on the ward. Ritmala-Castren, M., Salanterä, S., Holm, A., et al.[2021]

Sleep deficiency is a widespread issue among hospitalized patients, influenced by factors like existing health conditions and the hospital environment, which can negatively affect multiple organ systems.

To improve patient outcomes, it's crucial to enhance objective sleep measurement methods in hospitals and standardize study protocols to better assess the effectiveness of sleep promotion strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding Insult to Injury: Sleep Deficiency in Hospitalized Patients. Mansour, W., Knauert, M.[2023]

Sleep deprivation is linked to serious health issues such as increased risk of all-cause mortality, diabetes, and cardiovascular disease, highlighting the importance of addressing sleep disorders for public health.

Treating obstructive sleep apnea is a cost-effective healthcare intervention, providing significant quality-adjusted life years gained compared to other medical therapies, making it a valuable focus for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The public health and safety consequences of sleep disorders. Sigurdson, K., Ayas, NT.[2007]

A sleep health program consisting of four weekly group sessions significantly improved both objective and self-reported sleep parameters among 63 members of the German Armed Forces, demonstrating its effectiveness as a workplace health promotion tool.

Participants in the treatment group experienced notable improvements in sleep quality metrics, including sleep efficiency and latency to persistent sleep, with moderate effects on daytime sleepiness, indicating the program's potential as a preventive measure for sleep issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Workplace-Based Sleep Health Program on Sleep in Members of the German Armed Forces. Sauter, C., Kowalski, JT., Stein, M., et al.[2020]

Implementing a Sleep Program in the surgical intensive care unit significantly improved patient satisfaction with sleep by 28 percentage points, highlighting the importance of a healing environment for hospitalized patients.

The project focused on changing sleep management practices based on evidence-based approaches, which can lead to better healing and reduced stress for stable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting sleep in the adult surgical intensive care unit patients to prevent delirium. Hata, RK., Han, L., Slade, J., et al.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8196727/

Sleep Health Promotion Interventions and Their Effectiveness The aim of this umbrella review is to determine what non-pharmacological sleep health interventions have been evaluated among healthy populations.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12372062/

Who Benefits the Most from Sleep Hygiene Education? ... More favorable initial scores, fewer chronic conditions, and older age were the strongest predictors of positive outcomes following SLEEP.

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.6974

The Impact of a Randomized Sleep Education Intervention for ... In a pilot of a sleep health promotion program, lower sleep disturbances resulted in lower depression scores as measured by the Patient Reported Outcomes ...

4. cdc.gov cdc.gov/pcd/issues/2023/23_0197.htm

Sleep Deprivation, Sleep Disorders, and Chronic Disease Inadequate sleep disrupts critical neural processes and impairs cognitive functioning (14,15). Altering these processes provides a mechanistic ...

5. 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.

6. 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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10664020/

The need to promote sleep health in public health agendas ... Data from the CDC (appendix p 32) show that the prevalence of less than 7 h sleep per 24 h period overlaps with poor general health, poor mental health, poor ...

8. cdc.gov cdc.gov/cdi/indicator-definitions/sleep.html

Sleep | Chronic Disease Indicators We can promote sleep health through research and surveillance, public and provider education, clinical guidance, and traffic safety education.

9. nhlbi.nih.gov nhlbi.nih.gov/health-topics/education-and-awareness/sleep-health

Sleep Health - NHLBI - NIH The NHLBI offers many resources on sleep, including publications and videos, to help patients, their families, and health professionals.

10. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.7734

Workplace Interventions to Promote Sleep Health and an Alert ... The intervention significantly improved self-reported sleep quality and reduced the number of participants who had poor sleep quality by 20% in ...