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

Trial Summary

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 data supports the effectiveness of the treatment SIESTA for improving sleep quality?

The umbrella review on sleep health promotion interventions suggests that behavior change methods and mind-body exercises can effectively improve sleep quality. These findings imply that similar approaches, potentially included in the SIESTA treatment, may also be beneficial for enhancing sleep quality. ^{1 2 3 4 5}

Is sleep hygiene generally safe for improving sleep quality?

The research articles primarily discuss the safety of sleep medications, not sleep hygiene practices. Sleep hygiene, which includes habits like maintaining a regular sleep schedule and creating a restful environment, is generally considered safe and non-invasive for improving sleep quality. ^{6 7 8 9 10}

How does the SIESTA treatment for sleep quality differ from other treatments?

The SIESTA treatment focuses on sleep hygiene, which involves behaviors and practices that promote better sleep, such as managing stress, avoiding caffeine, and maintaining a regular sleep schedule. Unlike other treatments that may involve medication, SIESTA emphasizes lifestyle changes and individualized approaches to improve sleep quality. ^{1 11 12 13 14}

What is the purpose of this trial?

The main goal of this study is to evaluate the "SIESTA" intervention, a culturally and contextually tailored sleep hygiene intervention that has the potential to exert greater improvements in sleep hygiene and sleep outcomes for group that may be more vulnerable to poor sleep health. The main question is: do SIESTA participants have improved sleep outcomes, sleep hygiene behaviors and less sleep-related impairment compared to Control Group participants? Participants randomized to the SIESTA intervention will: 1. Attend 4 remotely administered group sleep hygiene education sessions 2. Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator 3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention. 4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality. Participants randomized to the Child Health Control condition will: 1. Attend 4 remotely administered group sessions covering general health topics 2. Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator 3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention. 4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality. A secondary goal of the study is to conduct a process evaluation to prepare for future larger scale use of the intervention in other urban school settings. This will entail assessing Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) of the program through several methods, such as by conducting in-depth interviews with research participants and their parents/guardians, as well as school staff and by looking at rates of participation in the program.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

What does sleep hygiene have to offer children's sleep problems? [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Natural history of excessive daytime sleepiness: a population-based 5-year longitudinal study. [2021]

4. Spain pubmed.ncbi.nlm.nih.gov

[Measurement of the perceived impact of sleep problems: the Spanish version of the functional outcomes sleep questionnaire and the Epworth sleepiness scale]. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Sleep Health Promotion Interventions and Their Effectiveness: An Umbrella Review. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Comparative short-term safety and efficacy of hypnotics: A quantitative risk-benefit analysis. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of subjective efficacy and safety of ramelteon in Japanese subjects with chronic insomnia. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

[Safety profile of zolpidem: two studies of 3805 patients by Swiss practitioners]. [2018]

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

Update on the safety considerations in the management of insomnia with hypnotics: incorporating modified-release formulations into primary care. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Hypnotic drug risks of mortality, infection, depression, and cancer: but lack of benefit. [2019]

11. England pubmed.ncbi.nlm.nih.gov

The role of sleep hygiene in promoting public health: A review of empirical evidence. [2022]

12. Czech Republic pubmed.ncbi.nlm.nih.gov

The Updating and Individualizing of Sleep Hygiene Rules for Non-clinical Adult Populations. [2023]

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

Psychometric properties of the Spanish version of the Sleep Hygiene Index. [2021]

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

Assessment of sleep hygiene using the Sleep Hygiene Index. [2022]