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NCT Number: NCT06661759

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 month–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Sleep Efficiency by Actigraphy

    Time frame: At baseline and at 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. Sleep efficiency, a key indicator of sleep quality, is calculated as total nighttime sleep divided by time in bed × 100%.

Secondary outcomes

  1. Sleep Onset Latency

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

    Sleep onset latency is defined as the duration (minutes) from bedtime to actigraphy-derived sleep onset.

  2. Wake After Sleep Onset (WASO)

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

    WASO is defined as the duration (minutes) scored as wake between sleep onset and final awakening.

  3. Total Nighttime Sleep

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

    Total nighttime sleep by actigraphy is defined as the total duration scored as sleep within the nocturnal rest interval.

  4. Daily 24-hour Sleep Duration

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

    Daily 24-hour sleep duration is defined as the total duration scored as sleep.

  5. Children's Sleep Habits Questionnaire (CSHQ)

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

    The CSHQ is a 45-item parent-reported questionnaire used to assess sleep behaviors in children.

  6. Child Behavior Checklist (CBCL)

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

    CBCL is a parent-report instrument that evaluates behavioral and emotional problems in children.

  7. Pittsburgh Sleep Quality Index

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

    The Pittsburgh Sleep Quality Index (PSQI) is used to assess the overall sleep quality of parents, with higher scores indicating greater sleep disturbances.

  8. Center for Epidemiologic Studies Depression Scale

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shao-Yu Tsai

CONTACT

[email protected]

+886223123456 ext. 262962

Yi-Shan Sung

CONTACT

[email protected]

+886223123456 ext. 288904

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 28, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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