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Not yet recruiting NCT07696442

Sleep, Music, And Research Trial 2.0

No phase Interventional Epilepsy in Children Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Music-based intervention, Active Control Placebo.
Who it may be relevant to
Registry conditions: Epilepsy in Children, Epilepsy. Basic parameters: 18 months — 9 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Music-Based Intervention for Pediatric Epilepsy

Overview

The goal of this clinical trial is to learn if a music-based intervention works to improve sleep and health in children with epilepsy and their parents. The main question it aims to answer is: Does the music-based intervention improve sleep and health for both the children and their parents?

Detailed description

Researchers will compare two different music modules, an experimental module and a control module, to determine if the experimental module yields better outcomes.

Participants will:

1. Listen to one of the two assigned music modules twice a day (once before bedtime and once after waking up) for 6 months. 2. Complete 4 assessments, include wearing an activity and sleep tracking device, keeping a daily sleep diary, and filling out questionnaires. 3. Maintain a diary to record any seizure activity.

Interventions

  • Behavioral Music-based intervention
    Participants will listen to a standardized nighttime music piece within approximately 30 minutes before their habitual bedtime and a daytime intervention music piece upon waking each day for 6 months.
  • Behavioral Active Control Placebo
    Participants will listen to a standardized nighttime music piece within approximately 30 minutes before their habitual bedtime and a daytime placebo music piece upon waking each day for 6 months.

Primary outcome measures

  • Sleep Efficiency [Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization]
Secondary outcome measures (8)
  • Total Nighttime Sleep [Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization]
  • Daily 24-hour Sleep Duration [Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization]
  • Sleep Onset Latency [Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization]
  • Wake After Sleep Onset [Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization]
  • Children's Sleep Habits Questionnaire (CSHQ) [Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization]
  • Child Behavior Checklist (CBCL) [Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization]
  • Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization]
  • Center for Epidemiologic Studies Depression Scale [Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization]

Eligibility criteria

Inclusion criteria

  • Children aged between 1.5 and 9 years with epilepsy;
  • Parents with sufficient Chinese language proficiency and skills to comprehend the study procedures and complete questionnaires.

Exclusion criteria

  • Children who have severe hearing loss even with the use of hearing devices;
  • 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 preclude differentiation of sleep and wake states via actigraphy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT07696442 · 202601052RINC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗