Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinic-based and technology-supported sleep intervention.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: 18 months — 9 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Sleep problems are more common and more severe in children with epilepsy. The purpose of this study is to develop and evaluate the effect of a clinic-based and technology-supported sleep intervention for improving sleep and health in children with epilepsy and their parents.
Detailed description
Participants in the intervention group will receive a standard pediatric neurology care plus a hybrid in-person and digital sleep education program.
Interventions
- Behavioral 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.
Primary outcome measures
- Sleep Efficiency by Actigraphy [Time frame: At baseline and at 3, 6, and 12 months after randomization.]
Secondary outcome measures (8)
- Sleep Onset Latency [Time frame: At baseline and at 3, 6, and 12 months after randomization.]
- Wake After Sleep Onset (WASO) [Time frame: At baseline and at 3, 6, and 12 months after randomization.]
- Total Nighttime Sleep [Time frame: At baseline and at 3, 6, and 12 months after randomization.]
- Daily 24-hour Sleep Duration [Time frame: At baseline and at 3, 6, and 12 months after randomization.]
- Children's Sleep Habits Questionnaire (CSHQ) [Time frame: At baseline and at 3, 6, and 12 months after randomization.]
- Child Behavior Checklist (CBCL) [Time frame: At baseline and at 3, 6, and 12 months after randomization.]
- Pittsburgh Sleep Quality Index [Time frame: At baseline and at 3, 6, and 12 months after randomization.]
- Center for Epidemiologic Studies Depression Scale [Time frame: At baseline and at 3, 6, and 12 months after randomization.]
Eligibility criteria
Inclusion criteria
- Children aged between 1.5 and 9 years with a confirmed diagnosis of epilepsy.
- Parents with sufficient Chinese language skills to fully comprehend the trial and complete questionnaires.
Exclusion criteria
- Children who are bedridden.
- Children with a documented sleep disorder, such as obstructive or central sleep apnea and sleep-related movement disorders
- Children with severe motor dysfunction that prevents accurate sleep-wake differentiation via actigraphy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Taiwan · 1 center
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT06661759 · 202402064RINE