SLEEP Program for Improving Sleep

Overseen By Robin Tucker, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michigan State University

Disqualifiers: Younger than 40 years

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

210 Participants Needed

Trial Summary

What is the purpose of this trial?

This study tests the effectiveness of a new educational intervention designed to improve sleep outcomes among an older adult population.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the SLEEP program treatment?

Research shows that a four-session Sleep Intervention Program improved sleep for older adults, and behavioral treatments for insomnia have led to significant improvements in sleep quality, such as reduced time to fall asleep and fewer awakenings during the night. ^{1 2 3 4 5}

Is the SLEEP Program safe for humans?

The SLEEP Program, also known as the Sleep Intervention Program or Behavioral Sleep Intervention, has been tested in various studies with different groups, including older adults and adolescents. These studies did not report any safety concerns, suggesting that the program is generally safe for humans. ^{4 6 7 8 9}

How is the SLEEP program treatment different from other treatments for sleep issues?

The SLEEP program is unique because it focuses on behavioral interventions, such as sleep compression, stimulus control, and sleep hygiene, rather than medication. This approach aims to improve sleep habits and behaviors, making it different from treatments that rely on drugs or other medical interventions. ^{4 8 9 10 11}

Eligibility Criteria

This trial is for older adults interested in improving their sleep through a new educational program called the SLEEP program. To participate, individuals must choose to enroll in this specific program. However, those under the age of 40 are not eligible to join.

Inclusion Criteria

I have decided to join the SLEEP program.

Exclusion Criteria

I am younger than 40 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the SLEEP educational intervention

Duration not specified

Follow-up

Participants are monitored for changes in sleep quality, duration, daytime sleepiness, insomnia symptoms, and sleep hygiene habits

6 months

Treatment Details

Interventions

• SLEEP program

Trial Overview The study is examining how effective the SLEEP program is at enhancing sleep quality among older adults. Participants will engage with this educational intervention designed specifically to address sleep issues in this population.

Participant Groups

Group I: Experimental Experimental Treatment 1 Intervention

Participants who participated in the SLEEP program.

Group II: Control Active Control 1 Intervention

Participants who did not participate in the SLEEP program.

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

Findings from Research

In a clinical case series study of 47 patients with primary insomnia, behavioral treatment led to an average improvement of 43%, indicating significant effectiveness in real-world settings.

Patients experienced a 65% reduction in sleep latency, a 46% decrease in nightly awakenings, a 48% reduction in wake time after sleep onset, and a 13% increase in total sleep time, demonstrating the treatment's substantial impact on sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral treatment of insomnia: a clinical case series study. Perlis, M., Aloia, M., Millikan, A., et al.[2022]

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]

The 4-week behavioral Sleep Intervention Program (SIP) significantly improved sleep efficiency and reduced nighttime awakenings in older adults compared to an information-only control, with benefits persisting at a 4-month follow-up.

Participants in the SIP group experienced fewer disturbances during the day, indicating that the intervention may enhance overall daily functioning, although no differences in total sleep time were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Four-Session Sleep Intervention Program Improves Sleep for Older Adult Day Health Care Participants: Results of a Randomized Controlled Trial. Martin, JL., Song, Y., Hughes, J., et al.[2022]

A quality improvement project at Johns Hopkins Hospital aimed to enhance sleep quality for critically ill patients in the ICU by implementing a structured four-step framework that included evidence-based interventions and staff education.

The project highlighted the importance of addressing local barriers and measuring adherence to sleep-promoting interventions, although challenges remain in maintaining long-term adherence and sustainability of these practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing, implementing, and evaluating a multifaceted quality improvement intervention to promote sleep in an ICU. Kamdar, BB., Yang, J., King, LM., et al.[2022]

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]

The quality improvement project at a large U.S. children's hospital successfully increased adherence to safe sleep practices, with Safe Sleep Environment audits showing improvement from 23% to 34% after the intervention (p<0.001).

Staff confidence in educating caregivers about safe sleep practices significantly increased, highlighting the effectiveness of the multifaceted educational approach in promoting infant safety and potentially reducing infant mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Safe Sleep Practices into a Pediatric Hospital: Outcomes of a Quality Improvement Project. Rowe, AD., Sisterhen, LL., Mallard, E., et al.[2017]

A simple education program that included a 90-minute lecture and a 2-week practice session significantly improved sleep knowledge and habits among 6th-year medical students, with notable enhancements in sleep quality and attitudes towards sleep management.

Students who participated in both the lecture and practice learning session showed greater improvements in sleep-related issues, such as nightmares and daytime sleepiness, compared to those who only attended the lecture, highlighting the effectiveness of hands-on practice in medical education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preparation and effect of a behavioral science-based education program for sleep improvement among medical students]. Ueda, M., Adachi, Y., Hayama, J., et al.[2011]

A behavior modification program taught to parents in a single 45-minute consultation significantly improved sleep performance in newborns, with intervention infants sleeping an average of 1.3 hours more per day at 6 weeks and 1.2 hours more at 12 weeks compared to the control group.

The intervention led to a higher percentage of days where infants achieved 15 hours or more of total sleep in 24 hours (62% in the intervention group vs. 36% in the control group), indicating a meaningful impact on sleep quality without affecting crying time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a consultation teaching behaviour modification on sleep performance in infants: a randomised controlled trial. Symon, BG., Marley, JE., Martin, AJ., et al.[2020]

A school-based motivational sleep education program combined with bright light therapy (BLT) and/or parental involvement significantly improved sleep knowledge, sleep onset latency, total sleep time, and mood among 193 adolescents over a 4-week period.

All intervention groups showed similar benefits compared to the control group, particularly for students with delayed sleep timing, suggesting that these educational strategies can effectively enhance sleep health in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of novel school-based interventions for adolescent sleep problems: does parental involvement and bright light improve outcomes? Bonnar, D., Gradisar, M., Moseley, L., et al.[2019]

Participants in a 12-week app-based sleep coaching program showed significant improvements in sleep quality, with an average reduction in sleep latency by 11 minutes and an increase in total sleep time by about 44 minutes.

41% of participants who initially used sleep aids stopped using them by the end of the program, indicating that the coaching intervention may effectively reduce reliance on sleep medications, especially for those with poorer sleep efficiency or shorter sleep duration at the start.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

App-Supported Sleep Coaching: Implications for Sleep Duration and Sleep Quality. Gorovoy, SB., Campbell, RL., Fox, RS., et al.[2023]

References

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

Behavioral treatment of insomnia: a clinical case series study. [2022]

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

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

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

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

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

A Four-Session Sleep Intervention Program Improves Sleep for Older Adult Day Health Care Participants: Results of a Randomized Controlled Trial. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Developing, implementing, and evaluating a multifaceted quality improvement intervention to promote sleep in an ICU. [2022]

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

Integrating Safe Sleep Practices into a Pediatric Hospital: Outcomes of a Quality Improvement Project. [2017]

8. Japan pubmed.ncbi.nlm.nih.gov

[Preparation and effect of a behavioral science-based education program for sleep improvement among medical students]. [2011]

9. Australia pubmed.ncbi.nlm.nih.gov

Effect of a consultation teaching behaviour modification on sleep performance in infants: a randomised controlled trial. [2020]

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

Evaluation of novel school-based interventions for adolescent sleep problems: does parental involvement and bright light improve outcomes? [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

App-Supported Sleep Coaching: Implications for Sleep Duration and Sleep Quality. [2023]