Clinic-based and Technology-Supported Sleep Intervention for Pediatric Epilepsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Objective sleep parameter by actigraphy
Study Overview
Brief Summary
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.
Detailed Description
Participants in the intervention group will receive a standard pediatric neurology care plus a hybrid in-person and digital sleep education program.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Months to 9 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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 prevents accurate sleep-wake differentiation via actigraphy.
Arms & Interventions
Usual care group
standard pediatric neurology care
Experimental intervention group
standard pediatric neurology care plus a hybrid in-person and digital sleep education program
Intervention: Clinic-based and technology-supported sleep intervention (Behavioral)
Outcomes
Primary Outcomes
Objective sleep parameter by actigraphy
Time Frame: Baseline, 3 , 6 , and 12 months after randomization
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. The monitor is a wristwatch-like device with an accelerometer sensitive to body movement. Detected physical motion will be stored as activity counts at 30-second intervals and converted to sleep parameters. Outcome measures derived from actigraphy will include: 1. sleep quantity variables as measured by durations of nighttime, daytime, and total 24 hour sleep. 2. sleep quality variable as measured by sleep efficiency.
Sleep Efficiency by Actigraphy
Time Frame: At baseline and at 3, 6, and 12 months after randomization.
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%.
Secondary Outcomes
- Sleep Onset Latency(At baseline and at 3, 6, and 12 months after randomization.)
- Wake After Sleep Onset (WASO)(At baseline and at 3, 6, and 12 months after randomization.)
- Total Nighttime Sleep(At baseline and at 3, 6, and 12 months after randomization.)
- Daily 24-hour Sleep Duration(At baseline and at 3, 6, and 12 months after randomization.)
- Children's Sleep Habits Questionnaire (CSHQ)(At baseline and at 3, 6, and 12 months after randomization.)
- Child Behavior Checklist (CBCL)(At baseline and at 3, 6, and 12 months after randomization.)
- Pittsburgh Sleep Quality Index(At baseline and at 3, 6, and 12 months after randomization.)
- Center for Epidemiologic Studies Depression Scale(At baseline and at 3, 6, and 12 months after randomization.)