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

March 3, 2026 updated by: National Taiwan University Hospital
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 born with a congenital, genetic, or orthopedic abnormality that limit their activities of daily living or impair their physical activity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Objective sleep parameter by actigraphy
Time Frame: 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.
Baseline, 3 , 6 , and 12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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