Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy
ConditionEpilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-9
SponsorNational Taiwan University Hospital
About this trial
Sleep problems are more common and more severe in children with epilepsy. The purpose of this study is to develop and evaluate the effect of a clinic-based and technology-supported sleep intervention for improving sleep and health in children with epilepsy and their parents.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged between 1.5 and 9 years with a confirmed diagnosis of epilepsy.
Parents with sufficient Chinese language skills to fully comprehend the trial and complete questionnaires.
Disqualifiers
Children who are bedridden.
Children with a documented sleep disorder, such as obstructive or central sleep apnea and sleep-related movement disorders
Children born with a congenital, genetic, or orthopedic abnormality that limit their activities of daily living or impair their physical activity.
Trial design
Design model
Parallel
Treatments tested in this trial
Clinic-based and technology-supported sleep intervention
BehavioralCATS sleep intervention: The in-person sleep education and consultation will consist of 3 face-to-face, one-on-one sessions held 3 months apart during the child's routine clinic visit.The digital component of the sleep intervention will extend in-person education by providing ongoing support. Participants will receive one digital session per week for four weeks after the baseline, 3-month, and 6-month clinic visits, totaling 12 sessions.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Experimental intervention groupExperimental treatment 1 intervention
Group B: Usual care groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Sleep Efficiency by Actigraphy
Actigraphy is an objective sleep measurement method that assesses physical motion through a small device worn on the non-dominant wrist. Children's sleep will be objectively assessed for 7 days using actigraphy at each assessment time point. Sleep efficiency, a key indicator of sleep quality, is calculated as total nighttime sleep divided by time in bed × 100%.
Time frame
At baseline and at 3, 6, and 12 months after randomization.Secondary outcomes
1
Sleep Onset Latency
Sleep onset latency is defined as the duration (minutes) from bedtime to actigraphy-derived sleep onset.
Time frame
At baseline and at 3, 6, and 12 months after randomization.2
Wake After Sleep Onset (WASO)
WASO is defined as the duration (minutes) scored as wake between sleep onset and final awakening.
Time frame
At baseline and at 3, 6, and 12 months after randomization.3
Total Nighttime Sleep
Total nighttime sleep by actigraphy is defined as the total duration scored as sleep within the nocturnal rest interval.
Time frame
At baseline and at 3, 6, and 12 months after randomization.4
Daily 24-hour Sleep Duration
Daily 24-hour sleep duration is defined as the total duration scored as sleep.
Time frame
At baseline and at 3, 6, and 12 months after randomization.Sponsors and contacts
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Source ClinicalTrials.gov