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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new educational program designed to help older adults improve their sleep. Participants will either join the SLEEP program, a behavioral sleep intervention, or be part of a control group without the intervention. The goal is to determine if the program can significantly improve sleep quality. It suits individuals over 40 who have difficulty sleeping well. As an unphased trial, this study allows participants to contribute to valuable research that could enhance sleep quality for many.

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 prior data suggests that this educational intervention is safe for improving sleep outcomes?

Research has shown that behavioral sleep programs are generally safe. Studies have found that programs like the SLEEP program are manageable for participants. For instance, a review of studies found that these sleep programs can improve sleep without causing significant side effects. These programs focus on building good sleep habits and routines, which are non-invasive and carry a low risk of harm.

In other studies, parents using similar sleep programs for their children reported positive improvements without serious side effects. The emphasis on healthy sleep habits and routines makes these programs safe for most people. Therefore, for those considering joining a trial for a sleep improvement program, evidence suggests these programs are generally safe and could enhance sleep without major risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SLEEP program is unique because it takes a behavioral approach to improve sleep, rather than relying on medications or supplements like many traditional treatments. Researchers are excited about this trial because it explores how structured sleep education and behavior modification can lead to better sleep patterns, without the side effects often associated with sleep medications. This program aims to empower participants with tools and techniques to naturally enhance their sleep quality, potentially offering a sustainable and holistic alternative to current options.

What evidence suggests that the SLEEP program is effective for improving sleep?

Studies have shown that sleep programs can greatly improve sleep quality. Research on older adults found that participants in similar programs slept more efficiently and woke up less during the night. Another study confirmed that these programs help people sleep longer, which is important for good health. These programs have consistently improved sleep for people of all ages. This trial will evaluate the SLEEP program, which could enhance sleep quality for older adults. Participants in the experimental arm will engage in the SLEEP program, while those in the control arm will not. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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 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]

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 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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10476177/

Behavioral interventions to extend sleep duration

The goal of this study was to examine the effects of behavioral sleep extension interventions on sleep duration outcomes in children and adults ≥ age 12.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5804980/

Sleep Intervention Program Improves Sleep for Older Adults

Results. SIP participants (n = 21) showed significant improvement on actigraphy sleep efficiency (p = .007), number of nighttime awakenings (p = .016), and ...

3.

sigmapubs.onlinelibrary.wiley.com

sigmapubs.onlinelibrary.wiley.com/doi/10.1111/jnu.13037

The efficacy of behavioral sleep intervention on sleep ...

This study aimed to assess the efficacy of behavioral sleep intervention in alleviating sleep problems, enhancing quality of life (QoL), and reducing ADHD ...

4.

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.

5.

nature.com

nature.com/articles/s41598-022-07762-8

Effectiveness of behavioral sleep interventions on ...

In children's aspects, when comparing BSIs with usual care, BSIs significantly decreased child sleep problems as reported by their parents.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7669566/

A Systematic Review and Meta-Analysis of Behavioral Sleep ...

The primary aim of this systematic review and meta-analysis was to evaluate the effect of behavioral sleep-promoting interventions on the sleep characteristics.

7.

jcsm.aasm.org

jcsm.aasm.org/doi/10.5664/jcsm.8488

Behavioral interventions for infant sleep problems: the role of ...

This study showed that parental cry tolerance and sleep-related cognitions predict treatment outcomes, with greater improvement in parent-reported sleep for ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S1087079224000662

An evaluation of psychosocial sleep interventions for ...

Twelve studies demonstrated positive sleep treatment effects and four demonstrated mixed effects. Collateral improvements were reported in child mental health ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02783560

Behavioral Sleep Intervention in Children With Disruptive ...

The sleep intervention focuses on sufficient sleep, healthy sleep habits, and a positive bedtime routine, with optional modules to help address bedtime problems ...

10.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36375604/

Implementation of Behavioral Interventions for Infant Sleep ...

Results: Sixty-four percent of parents reported implementing BSIs. The average age at intervention was 5.3 months (SD = 2.6).