Sleep, Music, And Research Trial 2.0

NCT07696442 | Not Yet Recruiting

• 1 other identifier: 202601052RINC
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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?

Conditions

Epilepsy in Children; Epilepsy

Keywords

Pediatric epilepsy; Music; Sleep

Outcome Measures

Primary Outcomes (1)

• 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%.

  Baseline, 2 weeks, 3 months, and 6 months after randomization

Secondary Outcomes (8)

• Total Nighttime Sleep

  Baseline, 2 weeks, 3 months, and 6 months after randomization

• Daily 24-hour Sleep Duration

  Baseline, 2 weeks, 3 months, and 6 months after randomization

• Sleep Onset Latency

  Baseline, 2 weeks, 3 months, and 6 months after randomization

• Wake After Sleep Onset

  Baseline, 2 weeks, 3 months, and 6 months after randomization

• Children's Sleep Habits Questionnaire (CSHQ)

  Baseline, 2 weeks, 3 months, and 6 months after randomization

Study Arms (2)

Experimental music intervention group

EXPERIMENTAL

Participants will listen to the experimental music module twice daily (before bedtime and upon waking) for 6 months.

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.

Behavioral: Active Control Placebo

Interventions

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.

Experimental music intervention group

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.

Active control music group

Eligibility Criteria

• Age: 18 Months - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Shao-Yu Tsai, PhD

CONTACT

+886223123456; stsai@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 14, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)