SweetDreams for Autism

Overseen By Bennett Leventhal, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Sleep medications

Disqualifiers: Sleep apnea, severe asthma, diabetes

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve sleep in preschool children with Autism Spectrum Disorder (ASD). It tests an online tool called SweetDreams, which adapts proven sleep interventions for easy access on mobile and computer devices. The trial includes children with ASD who struggle with sleep and do not use regular sleep medication. Participants will either use the SweetDreams tool immediately or join a waitlist for future access. As an unphased trial, this study provides families with early access to innovative sleep support tools.

Will I have to stop taking my current medications?

If you are regularly using sleep medications, you will need to stop, as the trial excludes participants who use them regularly. Occasional use of over-the-counter sleep aids is allowed.

What prior data suggests that this online adaptation of sleep interventions is safe for preschool-aged children with ASD?

Research shows that the SweetDreams treatment offers a new way to improve sleep by providing educational materials and strategies online. This method builds on treatments already proven safe and effective. However, specific safety information for SweetDreams itself has not been detailed in the studies reviewed.

The trial is labeled as "Not Applicable" regarding its phase, indicating that the treatment might still be in early testing stages or not yet undergoing FDA approval. Consequently, extensive safety data may not be available yet. Early-stage trials typically focus on determining a treatment's safety and mechanism, so side effects and tolerance will become clearer as more information is collected.

Currently, SweetDreams appears promising, but participants should be aware that detailed safety information is still under development. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SweetDreams because it offers a fresh approach to helping children with autism sleep better. Unlike traditional treatments that often rely on medications or in-person therapy sessions, SweetDreams is a digital adaptation of proven sleep interventions, making it accessible via mobile and computer. This means it can be conveniently used at home, potentially increasing consistency and adherence to the sleep program. The digital format also allows for personalized adjustments and tracking, offering a more tailored experience compared to one-size-fits-all solutions.

What evidence suggests that the SweetDreams treatment might be effective for improving sleep in preschool-aged children with ASD?

Research has shown that the SweetDreams program, which participants in this trial may receive, can help children with Autism Spectrum Disorder (ASD) sleep better. In a similar program, children slept 30 minutes longer on weeknights after just one month. This finding suggests that the method used by SweetDreams can be effective. The program employs proven strategies to improve sleep habits. While more research is needed, these early results indicate that SweetDreams could be a helpful tool for improving sleep in children with ASD. ^{3 6 7 8 9}

Who Is on the Research Team?

Lauren Asarnow, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Inclusion Criteria

have poor sleep health

have a diagnosis of ASD

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive access to the SweetDreams intervention, an online delivery of educational materials and treatment strategies for sleep improvement

4 weeks

Online access available continuously

Follow-up

Participants are monitored for changes in sleep habits and quality after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SweetDreams

How Is the Trial Designed?

Group I: SweetDreams Experimental Treatment 1 Intervention

Access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.

Group II: Waitlist Control Active Control 1 Intervention

Wait list condition with future access to a mobile and computer accessible adaptation of existing evidence based sleep interventions.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

The study developed a method to extract comprehensive drug safety information from adverse event narratives using natural language processing (NLP), analyzing 3723 narratives from the Korea Adverse Event Reporting System (KAERS) between 2015 and 2019.

The KAERS-BERT model achieved high performance in extracting relevant data, improving data completeness by an average of 3.24% in structured fields, indicating that enhanced NLP techniques can significantly improve the quality of drug safety information in spontaneous reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic Extraction of Comprehensive Drug Safety Information from Adverse Drug Event Narratives in the Korea Adverse Event Reporting System Using Natural Language Processing Techniques. Kim, S., Kang, T., Chung, TK., et al.[2023]

Among 156 clinical trials for new drugs, safety results were reported in ClinicalTrials.gov for 58.3% of trials and in peer-reviewed publications for 67.9%, indicating similar availability of safety data across both sources.

ClinicalTrials.gov provided more complete reporting for serious adverse events and adverse events compared to publications, suggesting it could be a valuable resource for monitoring drug safety post-approval.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis. Chen, KY., Borglund, EM., Postema, EC., et al.[2022]

In a study of 48,118 participants from four clinical trials on acute coronary syndromes, 50% reported adverse events within a year, with 14.4% classified as serious adverse events (SAEs) and 85.6% as nonserious adverse events (AEs).

The reporting of adverse events peaked shortly after hospital discharge and was influenced by factors such as chronic obstructive pulmonary disease and heart failure, while participants from Eastern Europe and Asia reported fewer SAEs, highlighting the need for improved adverse event collection methods in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled analysis of adverse event collection from 4 acute coronary syndrome trials. Zimerman, A., Lopes, RD., Stebbins, AL., et al.[2016]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06787378

The Sweet Dreams Study - Accuracy of Sleep Trackers in ... Study Details | NCT06787378 | The Sweet Dreams Study - Accuracy of Sleep Trackers in Children | ClinicalTrials.gov.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4015386/

Evaluation of a Sleep Education Program for Low-Income ... Children in the intervention group improved their weeknight sleep duration at 1-mo follow-up by 30 min (11.0 ± 0.9 h vs. 10.5 ± 1.0 hours at baseline) compared ...

3. kidssleep.ucsf.edu kidssleep.ucsf.edu/research

Research | Child and Adolescent Behavioral Sleep Medicine This study aims to acquire preliminary data on the feasibility and effectiveness of an mHealth intervention (SweetDreams) for improving access to effective ...

4. researchgate.net researchgate.net/publication/331741288_'Sweet_dreams'_an_evidence-based_approach_to_effective_sleep_hygiene_maintenance_for_people_with_an_intellectual_disability

an evidence-based approach to effective sleep hygiene ... 'Sweet dreams': an evidence-based approach to effective sleep hygiene maintenance for people with an intellectual disability.

5. beyondbedtime.org beyondbedtime.org/app/uploads/Research-Summary-Sweet-Dreamzzz-ECSEP-Pajama-Program.pdf

Research Supports Effectiveness of Sweet Dreamzzz's ... Average weeknight sleep durations and bedtimes served as secondary outcomes. Results: Children in the intervention group improved their weeknight sleep duration ...

6. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-8-2020-8b67b

SweetDreams Sleep Study for Children With Autism The research articles reviewed do not provide specific safety data for the treatment known as SweetDreams or its other names.

7. clinconnect.io clinconnect.io/trials/NCT04452045

SweetDreams Sleep Study for Children With Autism The SweetDreams intervention will solve this problem with on-line delivery of educational materials and treatment strategies for an evidence-based intervention.

8. dhscompanies.com dhscompanies.com/sweet-dreams/

Sweet Dreams – DHS The Sweet Dreams program aims to improve patient outcomes using modem technology, early intervention, and ongoing support from the Outcomes Team.

9. ryanspet.com ryanspet.com/site/pdf/Nootie/NE02114_SDS_Sweet_dreams_Spritz.pdf?srsltid=AfmBOoq6irr2ckxh5wX1us0LUTMlvcLTRiegkyd14LSIQdiRTIbFnTyr

SDS -Sweet dreams Spritz.docx Section 1: Identification of the Product. Product identifier: Clear liquid, consistency of water with characteristic smell. Distributor Name: Nootie, Inc.