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

Not Applicable

Not yet recruiting

• Conditions: Epilepsy

• Registration Number: NCT06661759
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-28
• Last Update Submitted: 2024-10-31
• Study Start: 2024-11-01
• Last Update Posted: 2024-11-04
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Objective sleep parameter by actigraphy	Baseline, 3 , 6 , and 12 months after randomization	Actigraphy is an objective sleep measurement method that assesses physical motion through a small device worn on the non-dominant wrist. Children's sleep will be objectively assessed for 7 days using actigraphy at each assessment time point. The monitor is a wristwatch-like device with an accelerometer sensitive to body movement. Detected physical motion will be stored as activity counts at 30-second intervals and converted to sleep parameters. Outcome measures derived from actigraphy will include: 1. sleep quantity variables as measured by durations of nighttime, daytime, and total 24 hour sleep.; 2. sleep quality variable as measured by sleep efficiency.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan