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

16 Participants Needed

Trial Summary

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 data supports the effectiveness of the Sleep Promotion Program treatment for sleep deprivation?

Research shows that sleep promotion programs in hospitals can improve sleep quality and patient satisfaction. For example, a study in a surgical intensive care unit found that implementing a sleep program increased patient satisfaction with sleep by 28 percentage points, suggesting that structured sleep interventions can be effective. ^{1 2 3 4 5}

Is the Sleep Promotion Program safe for humans?

There is no specific safety data available for the Sleep Promotion Program itself, but general sleep education programs have been implemented in workplaces without reported safety issues. ^{6 7 8 9 10}

How is the Sleep Promotion Program treatment different from other treatments for sleep deprivation?

The Sleep Promotion Program is unique because it focuses on education and behavioral strategies to improve sleep, rather than relying on medication. This approach may include webinars and online resources to help individuals understand and improve their sleep habits, making it different from drug-based treatments that enhance slow-wave sleep. ^{6 8 10 11 12}

What is the purpose of this trial?

Investigators developed a brief, scalable, behavioral Sleep Promotion Program (SPP) for adolescents with short sleep duration and sleep-wake irregularity, which relies on one individual session and smart phone technology to deliver evidence-based strategies. This open trial portion of the R34 will focus on conducting an open trial (n=8) to iteratively refine provider training, implementation procedures, and SPP program, per participant and staff feedback.

Research Team

Jessica C Levenson

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Adding Insult to Injury: Sleep Deficiency in Hospitalized Patients. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Sleep rounds: a multidisciplinary approach to optimize sleep quality and satisfaction in hospitalized patients. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Promoting sleep in the adult surgical intensive care unit patients to prevent delirium. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Providing Evidence-Based Care, Day and Night: A Quality Improvement Initiative to Improve Intensive Care Unit Patient Sleep Quality. [2022]

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

Sleep improvement intervention and its effect on patients' sleep on the ward. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of a Workplace-Based Sleep Health Program on Sleep in Members of the German Armed Forces. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

The public health and safety consequences of sleep disorders. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Workplace-Based Sleep Education Program. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Sleep promotion, hospital practice and recovery from illness. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Tiagabine is associated with sustained attention during sleep restriction: evidence for the value of slow-wave sleep enhancement? [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Sleep deprivation in two Saskatchewan First Nation communities: a public health consideration. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Slow wave sleep enhancement with gaboxadol reduces daytime sleepiness during sleep restriction. [2021]