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NCT05373537
Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism
NA trial testing Cognitive behavioral therapy for Insomnia in Autism Spectrum Disorder in 80 participants. Participants enrolled and being followed up; not accepting new ones.
15 December 2026
Quick facts
| Lead sponsor | University of Pennsylvania |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 5 November 2022 |
| Primary completion | 15 December 2026 |
| Estimated completion | 15 December 2026 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Cognitive behavioral therapy for Insomnia
Conditions studied
- Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →
- Insomnia Chronic — all drugs for Insomnia Chronic →
- Caregiver Burden — all drugs for Caregiver Burden →
Sponsor
University of Pennsylvania
Who can join
Adults 3 to 100, any sex, with Autism Spectrum Disorder or Insomnia Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Autism Spectrum Disorder (ASD) represents one of the most perplexing neurobiological disorders with a prevalence of 1 in 54 children. The lifelong challenging and disruptive behaviors often associated with ASD requires caregivers to change their behavior and modify their environments to provide an ecosystem for optimal outcomes for their child, family and themselves. ASD behaviors can have significant impact on caregivers mental health and family functioning, including the ability to develop and maintain healthy sleep routines. The caregiving population in US has a high prevalence of insomnia; two thirds of caregivers experiencing difficulties falling and/or staying asleep. The prevalence of insomnia in children with ASD is equally high, 60-80% experiencing night waking contributing to poor daytime behavior and disrupted sleep in the caregivers. This pilot RCT will focus on improving caregivers sleep in the context of caring for a child with ASD and insomnia with a multi-disciplinary team. The investigators will compare a home-based tailored CBT for Insomnia (CBT-I) versus a web-based Way to Health CBT-I intervention. This data will support a larger RCT with the Department of Defense funding opportunity through the Congressionally Directed Medical Research Program. This Autism Research Program focuses on improving lives of those living with ASD.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05373537
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Currently open trials in the same condition.
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Other University of Pennsylvania trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05373537 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Pennsylvania
- Last refreshed: 8 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05373537.
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