N/A
N=20
SweetDreams Sleep Study for Children With Autism
Autism Spectrum Disorder · Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT04452045 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Change in Children's Sleep Habits Questionnaire (CSHQ) — -8.78; -.59 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SweetDreams (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Children's Sleep Habits Questionnaire (CSHQ) |
-8.78; -.59 | — |
| SECONDARY Change in Pittsburgh Sleep Quality Index (PSQI) |
-3.36; .24 | — |
Summary
This proposal will acquire preliminary data on the feasibility and effectiveness of an innovative and scalable strategy for improving access to effective sleep health care for preschool-aged children with Autism Spectrum Disorder (ASD). The investigators will develop and test an on-line delivery adaptation of the existing behavioral sleep interventions for preschool aged children.
Eligibility Criteria
Inclusion Criteria
- have poor sleep health
- have a diagnosis of ASD
Exclusion Criteria
- any regular sleep medication use (this does not include occasional over the counter sleep aid)
- known sleep apnea
- unstable major medical conditions (e.g. severe asthma, diabetes).
Data sourced from ClinicalTrials.gov (NCT04452045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.