Epilepsy, Epilepsy in Children
Conditions
Keywords
Pediatric epilepsy, Music, Sleep
Brief summary
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
BEHAVIORALMusic-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.
BEHAVIORALActive 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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Months to 9 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Efficiency | Baseline, 2 weeks, 3 months, and 6 months after randomization | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Nighttime Sleep | Baseline, 2 weeks, 3 months, and 6 months after randomization | Total Nighttime Sleep is defined as the total duration (minutes) scored as sleep within the nocturnal rest interval. |
| Daily 24-hour Sleep Duration | Baseline, 2 weeks, 3 months, and 6 months after randomization | Daily 24-hour sleep duration is defined as total nighttime sleep plus nap duration. |
| Sleep Onset Latency | Baseline, 2 weeks, 3 months, and 6 months after randomization | Sleep onset latency is defined as the duration (minutes) from diary-reported bedtime to actigraphy-derived sleep onset. |
| Wake After Sleep Onset | Baseline, 2 weeks, 3 months, and 6 months after randomization | Wake after sleep onset (WASO) is defined as the duration (minutes) scored as wake between sleep onset and final awakening. |
| Children's Sleep Habits Questionnaire (CSHQ) | Baseline, 2 weeks, 3 months, and 6 months after randomization | 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. |
| Child Behavior Checklist (CBCL) | Baseline, 2 weeks, 3 months, and 6 months after randomization | 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. |
| Pittsburgh Sleep Quality Index (PSQI) | Baseline, 2 weeks, 3 months, and 6 months after randomization | 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. |
| Center for Epidemiologic Studies Depression Scale | Baseline, 2 weeks, 3 months, and 6 months after randomization | 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. |
Countries
Taiwan
Contacts
CONTACTShao-Yu Tsai, PhD
Outcome results
None listed