Sleep Hygiene for Sleep Quality

(SIESTA Trial)

Recruiting at 1 trial location

Overseen By Daphne Koinis-Mitchell, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Must not be taking: Any condition medications

Disqualifiers: Medical, psychiatric, developmental conditions, others

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

Compensation: Varies

Number of Visits: 8

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called SIESTA to determine if it can improve sleep habits and outcomes for middle schoolers. It focuses on sleep hygiene, which includes healthy sleep behaviors like getting enough rest and reducing nighttime disruptions. Participants will attend group sessions, complete surveys, and wear sleep watches to track sleep patterns. The trial seeks middle school students who sleep less than 9 hours a night and live and attend school in certain districts. As an unphased trial, participants can contribute to research that may enhance sleep health for students nationwide.

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

The trial does not specify if you need to stop taking your current medications, but it excludes children who are taking medicine for any condition that might affect their ability to participate.

What prior data suggests that the SIESTA intervention is safe for improving sleep hygiene?

Research shows that the SIESTA program, designed to improve sleep habits for urban Latino middle school children, has been tested for safety and effectiveness. Studies have found that sleep programs like SIESTA are usually safe and well-tolerated. Similar programs have helped people of different ages with sleep problems without reporting major side effects.

SIESTA focuses on teaching children and their families how to improve sleep habits, making it a very low-risk approach. The program includes group sessions and family meetings to learn about better sleep. Since it involves no medication, the risk of side effects is reduced.

Although some studies on sleep programs show mixed results, this type of program is generally safe for participants. Therefore, participants can feel confident about the safety of the SIESTA program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SIESTA intervention because it tailors sleep hygiene education specifically for urban Latino middle schoolers, addressing cultural and environmental factors unique to this group. Unlike standard sleep education that offers generic advice, SIESTA incorporates personalized sessions that involve both the children and their families, promoting a holistic approach to improving sleep quality. The program also uses daily feedback collected through a digital platform, helping families set and track personalized sleep goals, which could lead to more effective and lasting improvements in sleep habits compared to traditional methods.

What evidence suggests that the SIESTA intervention is effective for improving sleep quality?

Research has shown that the SIESTA program, which participants in this trial may receive, can improve sleep. In an initial study, people using SIESTA slept longer and developed better sleep habits than those who did not. This finding suggests that SIESTA can help people establish healthy sleep routines. The program is also tailored for urban Latino children, potentially increasing its effectiveness for them. Overall, evidence supports SIESTA as a promising method to enhance sleep quality and reduce sleep problems. ^{1 2 6 7 8}

Who Is on the Research Team?

Daphne Koinis-Mitchell, PhD

Principal Investigator

Alpert Medical School of Brown University

Ligia Chavez, PhD

Principal Investigator

University of Puerto Rico Medical Sciences Campus

Are You a Good Fit for This Trial?

This trial is for urban, Latino middle school children who may be experiencing poor sleep health. Participants and their guardians must commit to attending education sessions and completing surveys at multiple points during the study. They also need to wear sleep watches to track sleep patterns.

Inclusion Criteria

Children must live and go to school in one of the targeted school districts

Children must sleep no more than 9 hours on an average night

I am a middle schooler aged between 11-13.

Exclusion Criteria

My child does not have any serious medical, psychiatric, or developmental issues.

My child is not on medication that affects study participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants attend 4 remotely administered group sleep hygiene education sessions and 2 individualized sessions with a parent/guardian.

6 weeks

4 group sessions (remote), 2 family sessions (remote)

Follow-up

Participants are monitored for sleep outcomes and sleep hygiene behaviors at multiple time points post-intervention.

12 months

Assessments at baseline, end of treatment, and at 4, 8, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• SIESTA

Trial Overview The SIESTA intervention, which includes group and individualized sleep hygiene education sessions, is being tested against a control condition focusing on general health topics. The effectiveness of SIESTA will be measured by improvements in participants' sleep outcomes and behaviors.

How Is the Trial Designed?

Group I: Sleep Education plus Child Health attention control Experimental Treatment 1 Intervention

A facilitator from the community will deliver this attention control condition, which consists of the same number of sessions as SIESTA but will focus only on basic sleep hygiene education plus general child health topics (e.g., nutrition, physical activity, safety). It is expected that this will exert limited treatment effects on sleep hygiene, because it does not 1) involve effective behavioral approaches for this age group, or 2) include content tailored for urban Latinos.

Group II: SIESTA Experimental Treatment 1 Intervention

The SIESTA Intervention includes 4, 60-minute group remote sessions by a trained facilitator, and 2, 90-minute family sessions in their home 1 week after group Sessions 1 and 4. SIESTA incorporates key sleep hygiene principles and strategies critical to optimal sleep health in middle schoolers and tailored to urban Latino children's cultural background and urban setting. Areas of focus include the importance of adequate sleep duration, principles and strategies to enhance sleep hygiene, and characteristics of healthy sleep environments, and were developed with targeted goals. After intervention group Session 1, daily sleep questions about the child participant are completed, including key sleep parameters (bedtime, rise time, night awakenings) and sleep hygiene behaviors (daytime naps, electronics, caffeine use) via Qualtrics. Responses are summarized and presented pictorially in caregiver-child sessions to facilitate developing sleep goals for the youth and assess their progress.

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

University of Puerto Rico

Collaborator

Trials

69

Recruited

22,300+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

In a study of 987 Japanese adults with chronic insomnia, ramelteon 8 mg significantly reduced the time it took for patients to fall asleep (sleep latency) after just one week of treatment, compared to a placebo.

Ramelteon also improved total sleep time and sleep quality, and was well tolerated with no evidence of rebound insomnia after stopping the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of subjective efficacy and safety of ramelteon in Japanese subjects with chronic insomnia. Uchiyama, M., Hamamura, M., Kuwano, T., et al.[2022]

The Sleep Hygiene Index, tested on 632 subjects, shows that sleep hygiene behaviors are stable over time in a nonclinical population, indicating its reliability as a measurement tool.

The index is strongly correlated with sleep quality and somewhat with daytime sleepiness, supporting its validity in assessing sleep hygiene practices and their impact on overall sleep health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of sleep hygiene using the Sleep Hygiene Index. Mastin, DF., Bryson, J., Corwyn, R.[2022]

Melatonin receptor agonists have the lowest rate of adverse events (43.1 per 1000), while non-benzodiazepine benzodiazepine receptor agonists have the highest (255.0 per 1000), indicating a significant difference in safety profiles among insomnia medications.

Benzodiazepines showed the highest efficacy in improving sleep outcomes with an effect size of 1.94, while melatonin receptor agonists had the lowest efficacy (0.109), suggesting that histamine antagonists may offer the best risk-benefit ratio for treating insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative short-term safety and efficacy of hypnotics: A quantitative risk-benefit analysis. Cheung, JMY., Scott, H., Muench, A., et al.[2023]

The review analyzed 44 studies on sleep hygiene practices and their effects on sleep outcomes, such as sleep duration and onset latency, highlighting the need for clearer connections between specific sleep hygiene elements and their impacts.

The findings were organized by age group and intervention type, providing evidence-based recommendations for effective sleep hygiene practices while identifying areas that need further research to improve sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What does sleep hygiene have to offer children's sleep problems? Hall, WA., Nethery, E.[2020]

In two multicenter safety studies involving nearly 4,000 patients treated with zolpidem for insomnia, only 8.9% and 7.2% reported adverse events, indicating a relatively low incidence of side effects.

The most common adverse effects were related to the central nervous system, such as somnolence and confusion, but no new serious adverse events were identified, supporting the established safety profile of zolpidem.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety profile of zolpidem: two studies of 3805 patients by Swiss practitioners]. Ganzoni, E., Gugger, M.[2018]

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]

This umbrella review analyzed 35 systematic reviews and meta-analyses to evaluate non-pharmacological sleep health interventions in primarily healthy populations, highlighting effective strategies such as later school start times, behavior change methods, and mind-body exercises.

While some interventions like sleep education and relaxation techniques showed potential benefits for sleep quality, the evidence was less consistent, indicating a need for further research to solidify these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Health Promotion Interventions and Their Effectiveness: An Umbrella Review. Albakri, U., Drotos, E., Meertens, R.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11156421/

A Pilot Randomized Control Trial Demonstrating the Efficacy ... Results indicated high acceptability and greater improvement of sleep duration and behaviors in SIESTA versus control participants.

2. nature.com nature.com/articles/s41598-024-83291-w

Siesta characteristics mediated the association between ... Both regression models found that longer siesta duration was a risk factor for poor sleep quality. Mediation analysis demonstrated that sleep ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03954210

SIESTA: Sleep Intervention to Enhance Cognitive Status ... The objective of this study is to compare the efficacy of a sleep intervention on improving cognitive function in older adults with symptoms of insomnia.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1077722923000950

A Pilot Study of a Cognitive-Behavioral Sleep Intervention ... Quantitative findings indicate significant improvement in sleep hygiene. •. SIESTA was improved based on the experiences with this pilot study. Abstract.

5. cdn.mdedge.com cdn.mdedge.com/files/s3fs-public/issues/articles/jhm014010038.pdf

Effectiveness of SIESTA on Objective and Subjective ... We distributed pocket cards describing the mnemonic SIESTA (Screen patients for sleep disorders, Instruct patients on sleep hygiene, Eliminate disruptions ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1155/2017/7570352

The SIESTA Trial: A Randomized Study Investigating ... The present pilot study identified that acupressure is a safe, well-tolerated, and highly acceptable therapy in adult hemodialysis patients in a Western ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553725021000325

A Sleep Hygiene Intervention to Improve Sleep Quality for ... Although studies about sleep hygiene interventions to improve sleep have reported inconsistent findings [16,28], our findings must be interpreted with caution, ...

8. ctv.veeva.com ctv.veeva.com/study/a-sleep-hygiene-intervention-to-improve-sleep-health-in-urban-latino-middle-school-children

A Sleep Hygiene Intervention to Improve Sleep Health in ... The main goal of this study is to evaluate the "SIESTA" intervention, a culturally and contextually tailored sleep hygiene intervention that ...