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

NCT ID: NCT06661759

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-19

Study Completion Date

2027-12-31

Brief Summary

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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

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

Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Experimental intervention group

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

Group Type EXPERIMENTAL

Clinic-based and technology-supported sleep intervention

Intervention Type BEHAVIORAL

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.

Usual care group

standard pediatric neurology care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Months

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shao-Yu Tsai

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yi-Shan Sung

Role: CONTACT

+886223123456 ext. 288904

Shao-Yu Tsai

Role: CONTACT

+886223123456 ext. 262962

Facility Contacts

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Yi-Shan Sung

Role: primary

+88623123456 ext. 288904

Shao-Yu Tsai

Role: backup

+88623123456 ext. 262962

Other Identifiers

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202402064RINE

Identifier Type: -

Identifier Source: org_study_id

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