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?
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
144
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.
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.
National Taiwan University Hospital
Taipei, Taiwan
Sleep Efficiency
Sleep efficiency, measured objectively using actigraphy, is a key indicator of sleep quality. It is calculated as the ratio of total nighttime sleep time to time in bed, multiplied by 100%.
Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization
Total Nighttime Sleep
Total Nighttime Sleep is defined as the total duration (minutes) scored as sleep within the nocturnal rest interval.
Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization
Daily 24-hour Sleep Duration
Daily 24-hour sleep duration is defined as total nighttime sleep plus nap duration.
Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization
Sleep Onset Latency
Sleep onset latency is defined as the duration (minutes) from diary-reported bedtime to actigraphy-derived sleep onset.
Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization
Wake After Sleep Onset
Wake after sleep onset (WASO) is defined as the duration (minutes) scored as wake between sleep onset and final awakening.
Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization
Children's Sleep Habits Questionnaire (CSHQ)
The Children's Sleep Habits Questionnaire (CSHQ) is a 33-item parent-report questionnaire that assesses sleep behaviors in children. Items are rated on a 3-point scale, with higher scores indicating more sleep problems.
Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization
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Child Behavior Checklist (CBCL)
The Child Behavior Checklist (CBCL) is a 120-item parent-report instrument used to assess behavioral and emotional problems in children. Parents rate each item on a 3-point Likert scale, with higher scores indicating a greater presence of behavioral and emotional problems.
Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire that assesses parents' overall sleep quality. The 19 items are combined into seven component scores (0-3), which are summed to generate a global score ranging from 0 to 21. Higher scores indicate poorer sleep quality, with a global score \>5 suggesting significant sleep difficulties.
Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization
Center for Epidemiologic Studies Depression Scale
The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report questionnaire that assesses parents' depressive symptoms. Items are rated on a 4-point Likert scale (0-3), with higher scores indicating more severe depressive symptoms.
Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization