Sleep, Music, And Research Trial 2.0

Официальное название

Music-Based Intervention for Pediatric Epilepsy

Обзор

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?

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Sleep Efficiency [Срок оценки: Baseline, 2 weeks, 3 months, and 6 months after randomization]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT07696442 · 202601052RINC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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