Sleep, Music, And Research Trial 2.0 (SMART-2)

July 6, 2026 updated by: National Taiwan University Hospital

Music-Based Intervention for Pediatric Epilepsy

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:

  1. Does the music-based intervention improve sleep and health for both the children and their parents?
  2. How frequently and for how long do participants listen to the music?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shao-Yu Tsai, PhD
  • Phone Number: 288904 +886223123456
  • Email: stsai@ntu.edu.tw

Study Locations

  • Taiwan
    • Taiwan
      • Taipei, Taiwan, Taiwan, 100
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental intervention group
Participants will listen to the experimental music module twice daily (before bedtime and upon waking) for 6 months.
Behavioral: 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.
Placebo Comparator: Active control group
Participants will listen to the control music module twice daily (before bedtime and upon waking) for 6 months.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
Baseline, 2 weeks, 3 months, and 6 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 2 weeks, 3 months, and 6 months after randomization
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.
Baseline, 2 weeks, 3 months, and 6 months after randomization
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.
Baseline, 2 weeks, 3 months, and 6 months after randomization
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.
Baseline, 2 weeks, 3 months, and 6 months after randomization
Children's Sleep Habits Questionnaire (CSHQ)
Time Frame: Baseline, 2 weeks, 3 months, and 6 months after randomization
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)
Time Frame: Baseline, 2 weeks, 3 months, and 6 months after randomization
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
Time Frame: Baseline, 2 weeks, 3 months, and 6 months after randomization
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
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 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

July 6, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202601052RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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