Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy

National Taiwan University

Status: Enrolling

Conditions: Epilepsy

Treatments: Behavioral: Clinic-based and technology-supported sleep intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06661759

202402064RINE

Details and patient eligibility

About

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.

Full description

Participants in the intervention group will receive a standard pediatric neurology care plus a hybrid in-person and digital sleep education program.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 months to 9 years old

Volunteers: No Healthy Volunteers

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 with cerebral palsy or those 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

150 participants in 2 patient groups

Experimental intervention group

Experimental group

Description:

standard pediatric neurology care plus a hybrid in-person and digital sleep education program

Treatment:

Behavioral: Clinic-based and technology-supported sleep intervention

Usual care group

No Intervention group

Description:

standard pediatric neurology care