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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. It will also learn about the feasibility and acceptability of the music-based intervention.
The main questions it aims to answer are:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental intervention group | Experimental | Participants will listen to the experimental music module twice daily (before bedtime and upon waking) for 6 months. |
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| Active control group | Placebo Comparator | Participants will listen to the control music module twice daily (before bedtime and upon waking) for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music-based intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | Baseline, 2 weeks, 3 months, and 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Total Nighttime Sleep | Total Nighttime Sleep is defined as the total duration (minutes) scored as sleep within the nocturnal rest interval. | Baseline, 2 weeks, 3 months, and 6 months after randomization |
| Daily 24-hour Sleep Duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shao-Yu Tsai, PhD | Contact | +886223123456 | 288904 | stsai@ntu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan | 100 | Taiwan |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Active Control Placebo | Behavioral | 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. |
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Daily 24-hour sleep duration is defined as total nighttime sleep plus nap duration.
| 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. | 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. | Baseline, 2 weeks, 3 months, and 6 months after randomization |
| Children's Sleep Habits Questionnaire (CSHQ) | The CSHQ is a 45-item parent-reported questionnaire used to assess sleep behaviors in children. Higher scores indicate more sleep problems. | Baseline, 2 weeks, 3 months, and 6 months after randomization |
| Child Behavior Checklist (CBCL) | CBCL is a parent-report instrument that evaluates behavioral and emotional problems in children. | Baseline, 2 weeks, 3 months, and 6 months after randomization |
| Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index (PSQI) is used to assess the overall sleep quality of parents, with higher scores indicating greater sleep disturbances. | 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 questionnaire used to measure parents' symptoms of depression, with higher scores indicating more persistent symptoms. | Baseline, 2 weeks, 3 months, and 6 months after randomization |