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NCT Number: NCT07696442

Sleep, Music, And Research Trial 2.0

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?

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Key information

Conditions

Epilepsy in Children Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

18 month–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Sleep Efficiency

    Time frame: 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 outcomes

  1. Total Nighttime Sleep

    Time frame: 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.

  2. Daily 24-hour Sleep Duration

    Time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization

    Daily 24-hour sleep duration is defined as total nighttime sleep plus nap duration.

  3. Sleep Onset Latency

    Time frame: 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.

  4. Wake After Sleep Onset

    Time frame: 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.

  5. Children's Sleep Habits Questionnaire (CSHQ)

    Time frame: 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.

  6. Child Behavior Checklist (CBCL)

    Time frame: 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.

  7. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  8. Center for Epidemiologic Studies Depression Scale

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shao-Yu Tsai, PhD

CONTACT

[email protected]

+886223123456 ext. 288904

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Music-Based Intervention for Pediatric Epilepsy

Acronym: SMART-2

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 10, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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