Sleep, Music, And Research Trial 2.0

Sponsor
National Taiwan University Hospital
Study ID
NCT07696442
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Months - 9 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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?

Key Dates

First listed
Jul 10, 2026
Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Experimental music intervention group
    Participants will listen to the experimental music module twice daily (before bedtime and upon waking) for 6 months.
  • Placebo Comparator: Active control music group
    Participants will listen to the control music module twice daily (before bedtime and upon waking) for 6 months.

Primary Outcome Measure

Sleep Efficiency [ Time Frame: Baseline, 2 weeks, 3 months, and 6 months after randomization ]

Central Contacts

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