Epilepsy in ChildrenSMART-2NCT07696442
Sleep, Music, And Research Trial 2.0
A study testing Music-based intervention in people with Epilepsy in Children and Epilepsy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 months to 9 years
- Conditions the study is for
- Epilepsy in Children, Epilepsy
- What is being tested?
- Music-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Shao-Yu Tsai, PhD, +886223123456 ext. 288904, stsai@ntu.edu.tw
About this study
Official title: 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. The main question it aims to answer is: Does the music-based intervention improve sleep and health for both the children and their parents?
Read the 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:
- 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.
- Conditions
- Epilepsy in Children, Epilepsy
- Being tested
- Music-based intervention, Active Control Placebo
- Keywords
- Pediatric epilepsy, Music, Sleep
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music-based interventionBehavioural
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 PlaceboBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental music intervention group | Experimental | Participants will listen to the experimental music module twice daily (before bedtime and upon waking) for 6 months. Receives: Behavioral: Music-based intervention |
| Active control music group | Placebo comparator | Participants will listen to the control music module twice daily (before bedtime and upon waking) for 6 months. Receives: Behavioral: Active Control Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Baseline, 2 weeks, 3 months, and 6 months after randomization
Secondary outcomes (8)
Total Nighttime Sleep
Total Nighttime Sleep is defined as the total duration (minutes) scored as sleep within the nocturnal rest interval.
Measured: Baseline, 2 weeks, 3 months, and 6 months after randomization
Daily 24-hour Sleep Duration
Daily 24-hour sleep duration is defined as total nighttime sleep plus nap duration.
Measured: 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.
Measured: 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.
Measured: Baseline, 2 weeks, 3 months, and 6 months after randomization
Children's Sleep Habits Questionnaire (CSHQ)
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.
Measured: Baseline, 2 weeks, 3 months, and 6 months after randomization
Child Behavior Checklist (CBCL)
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.
Measured: Baseline, 2 weeks, 3 months, and 6 months after randomization
Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: 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 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.
Measured: Baseline, 2 weeks, 3 months, and 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy in ChildrenStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696442
- Sponsor's protocol ID
- 202601052RINC
- Acronym
- SMART-2
- Status last verified
- Oct 2026
- First submitted
- 6 Jul 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music-Based Intervention for Pediatric Epilepsy
- ClinicalTrials.gov ID
- NCT07696442
- Acronym / sponsor ID
- SMART-2 / 202601052RINC
- Conditions
- Epilepsy in Children, Epilepsy
- Keywords
- Pediatric epilepsy, Music, Sleep
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental music intervention group | Experimental | Behavioral: Music-based interventionParticipants will listen to the experimental music module twice daily (before bedtime and upon waking) for 6 months. |
| Active control music group | Placebo comparator | Behavioral: Active Control PlaceboParticipants will listen to the control music module twice daily (before bedtime and upon waking) for 6 months. |
Who may qualify
- Ages
- 18 months to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music-based interventionParticipants 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. | Behavioural | Experimental music intervention group |
| Active Control PlaceboParticipants 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. | Behavioural | Active control music group |
Primary outcome
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%.
8 secondary outcomes
Total Nighttime Sleep
Time frame: 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
Sleep Onset Latency
Time frame: 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
Children's Sleep Habits Questionnaire (CSHQ)
Time frame: 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
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music-based intervention in people with Epilepsy in Children and Epilepsy, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shao-Yu Tsai, PhD (+886223123456 ext. 288904, stsai@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency (time frame: Baseline, 2 weeks, 3 months, and 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.