Clinic-based and technology-supported sleep program for children with epilepsy
Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy
This program will test whether adding a hybrid in-person and digital sleep education program to standard pediatric neurology care improves sleep and overall health for children aged 1.5–9 with epilepsy and their parents.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Months to 9 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06661759 on ClinicalTrials.gov |
What this trial studies
This interventional study adds a hybrid sleep education program to standard pediatric neurology care for children with epilepsy. Participants in the intervention arm receive a combination of clinic-based sessions and digital modules aimed at improving child sleep habits and parental management strategies. Sleep quality, daytime functioning, and parent-reported health measures are collected using questionnaires and clinical follow-up. The program is delivered at National Taiwan University Hospital and is designed for Mandarin/Chinese-speaking families.
Who should consider this trial
Good fit: Ideal candidates are children aged 1.5–9 years with a confirmed diagnosis of epilepsy whose parents have sufficient Chinese language skills to participate and complete questionnaires.
Not a fit: Children who are bedridden, have a diagnosed primary sleep disorder (such as obstructive or central sleep apnea or sleep-related movement disorders), or have congenital, genetic, or orthopedic conditions that limit daily activities are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, the program could improve children's sleep quality and daytime functioning and reduce caregiver sleep-related stress, improving overall health for both children and parents.
How similar studies have performed: Behavioral and digital sleep interventions have improved sleep in other pediatric populations, but similar approaches have been less extensively tested specifically in children with epilepsy.
Eligibility criteria
Show full inclusion / exclusion 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 born with a congenital, genetic, or orthopedic abnormality that limit their activities of daily living or impair their physical activity.
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Shao-Yu Tsai — National Taiwan University
- Study coordinator: Yi-Shan Sung
- Email: yshansung33@ntu.edu.tw
- Phone: +886223123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.