Sleep, Music, And Research Trial 2.0
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-9
SponsorNational Taiwan University Hospital
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Music-based intervention
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
144 Participants
are divided into 2 treatment groupsGroup A: Experimental music intervention groupExperimental treatment 1 intervention
Group B: Active control music groupPlacebo comparator 1 intervention
Trial outcomes
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%.
Time frame
Baseline, 2 weeks, 3 months, and 6 months after randomizationSecondary outcomes
1
Total Nighttime Sleep
Total Nighttime Sleep is defined as the total duration (minutes) scored as sleep within the nocturnal rest interval.
Time frame
Baseline, 2 weeks, 3 months, and 6 months after randomization2
Daily 24-hour Sleep Duration
Daily 24-hour sleep duration is defined as total nighttime sleep plus nap duration.
Time frame
Baseline, 2 weeks, 3 months, and 6 months after randomization3
Sleep Onset Latency
Sleep onset latency is defined as the duration (minutes) from diary-reported bedtime to actigraphy-derived sleep onset.
Time frame
Baseline, 2 weeks, 3 months, and 6 months after randomization4
Wake After Sleep Onset
Wake after sleep onset (WASO) is defined as the duration (minutes) scored as wake between sleep onset and final awakening.
Time frame
Baseline, 2 weeks, 3 months, and 6 months after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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