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

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Clinic-based and technology-supported sleep intervention

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi-Shan Sung; Phone Number: 288904 +886223123456; Email: yshansung33@ntu.edu.tw
• Study Contact Backup: Name: Shao-Yu Tsai; Phone Number: 262962 +886223123456; Email: stsai@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yi-Shan Sung; Phone Number: 288904 +88623123456; Email: yshansung33@ntu.edu.tw
    • Contact: Shao-Yu Tsai; Phone Number: 262962 +88623123456; Email: stsai@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental intervention group; standard pediatric neurology care plus a hybrid in-person and digital sleep education program	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.
No Intervention: Usual care group; standard pediatric neurology care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Efficiency by Actigraphy	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. Sleep efficiency, a key indicator of sleep quality, is calculated as total nighttime sleep divided by time in bed × 100%.	At baseline and at 3, 6, and 12 months after randomization.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Onset Latency	Sleep onset latency is defined as the duration (minutes) from bedtime to actigraphy-derived sleep onset.	At baseline and at 3, 6, and 12 months after randomization.
Wake After Sleep Onset (WASO)	WASO is defined as the duration (minutes) scored as wake between sleep onset and final awakening.	At baseline and at 3, 6, and 12 months after randomization.
Total Nighttime Sleep	Total nighttime sleep by actigraphy is defined as the total duration scored as sleep within the nocturnal rest interval.	At baseline and at 3, 6, and 12 months after randomization.
Daily 24-hour Sleep Duration	Daily 24-hour sleep duration is defined as the total duration scored as sleep.	At baseline and at 3, 6, and 12 months after randomization.
Children's Sleep Habits Questionnaire (CSHQ)	The CSHQ is a 45-item parent-reported questionnaire used to assess sleep behaviors in children.	At baseline and at 3, 6, and 12 months after randomization.
Child Behavior Checklist (CBCL)	CBCL is a parent-report instrument that evaluates behavioral and emotional problems in children.	At baseline and at 3, 6, and 12 months after randomization.
Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index (PSQI) is used to assess the overall sleep quality of parents, with higher scores indicating greater sleep disturbances.	At baseline and at 3, 6, and 12 months after randomization.
Center for Epidemiologic Studies Depression Scale	The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item questionnaire used to measure parents' symptoms of depression, with higher scores indicating more persistent symptoms.	At baseline and at 3, 6, and 12 months after randomization.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Shao-Yu Tsai, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 202402064RINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No