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

NCT06661759 | Recruiting

• 1 other identifier: 202402064RINE
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Sleep Onset Latency

  At baseline and at 3, 6, and 12 months after randomization.

• Wake After Sleep Onset (WASO)

  At baseline and at 3, 6, and 12 months after randomization.

• Total Nighttime Sleep

  At baseline and at 3, 6, and 12 months after randomization.

• Daily 24-hour Sleep Duration

  At baseline and at 3, 6, and 12 months after randomization.

• Children's Sleep Habits Questionnaire (CSHQ)

  At baseline and at 3, 6, and 12 months after randomization.

Study Arms (2)

Experimental intervention group

EXPERIMENTAL

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

Behavioral: Clinic-based and technology-supported sleep intervention

Usual care group

NO INTERVENTION

standard pediatric neurology care

Interventions

Clinic-based and technology-supported sleep intervention 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.

Experimental intervention group

Eligibility Criteria

• Age: 18 Months - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Shao-Yu Tsai

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi-Shan Sung

CONTACT

+886223123456; yshansung33@ntu.edu.tw

Shao-Yu Tsai

CONTACT

+886223123456; stsai@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 8, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)