Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy
NCT ID: NCT06661759
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-11-19
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Experimental intervention group
standard pediatric neurology care plus a hybrid in-person and digital sleep education program
Clinic-based and technology-supported sleep intervention
CATS sleep intervention: The in-person sleep education and consultation will consist of 3 face-to-face, one-on-one sessions held 3 months apart during the child's routine clinic visit.The digital component of the sleep intervention will extend in-person education by providing ongoing support. Participants will receive one digital session per week for four weeks after the baseline, 3-month, and 6-month clinic visits, totaling 12 sessions.
Usual care group
standard pediatric neurology care
No interventions assigned to this group
Interventions
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Clinic-based and technology-supported sleep intervention
CATS sleep intervention: The in-person sleep education and consultation will consist of 3 face-to-face, one-on-one sessions held 3 months apart during the child's routine clinic visit.The digital component of the sleep intervention will extend in-person education by providing ongoing support. Participants will receive one digital session per week for four weeks after the baseline, 3-month, and 6-month clinic visits, totaling 12 sessions.
Eligibility Criteria
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Inclusion Criteria
* Parents with sufficient Chinese language skills to fully comprehend the trial and complete questionnaires.
Exclusion Criteria
* Children with a documented sleep disorder, such as obstructive or central sleep apnea and sleep-related movement disorders
* Children born with a congenital, genetic, or orthopedic abnormality that limit their activities of daily living or impair their physical activity.
18 Months
9 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Shao-Yu Tsai
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University
Locations
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National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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202402064RINE
Identifier Type: -
Identifier Source: org_study_id
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