Epilepsy
Conditions
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.
Interventions
BEHAVIORALClinic-based and technology-supported sleep intervention
CATS 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.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Months to 9 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Efficiency by Actigraphy | 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep Onset Latency | At baseline and at 3, 6, and 12 months after randomization. | Sleep onset latency is defined as the duration (minutes) from bedtime to actigraphy-derived sleep onset. |
| Wake After Sleep Onset (WASO) | At baseline and at 3, 6, and 12 months after randomization. | WASO is defined as the duration (minutes) scored as wake between sleep onset and final awakening. |
| Total Nighttime Sleep | At baseline and at 3, 6, and 12 months after randomization. | Total nighttime sleep by actigraphy is defined as the total duration scored as sleep within the nocturnal rest interval. |
| Daily 24-hour Sleep Duration | At baseline and at 3, 6, and 12 months after randomization. | Daily 24-hour sleep duration is defined as the total duration scored as sleep. |
| Children's Sleep Habits Questionnaire (CSHQ) | At baseline and at 3, 6, and 12 months after randomization. | The CSHQ is a 45-item parent-reported questionnaire used to assess sleep behaviors in children. |
| Child Behavior Checklist (CBCL) | At baseline and at 3, 6, and 12 months after randomization. | CBCL is a parent-report instrument that evaluates behavioral and emotional problems in children. |
| Pittsburgh Sleep Quality Index | At baseline and at 3, 6, and 12 months after randomization. | The Pittsburgh Sleep Quality Index (PSQI) is used to assess the overall sleep quality of parents, with higher scores indicating greater sleep disturbances. |
| Center for Epidemiologic Studies Depression Scale | At baseline and at 3, 6, and 12 months after randomization. | The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item questionnaire used to measure parents' symptoms of depression, with higher scores indicating more persistent symptoms. |
Countries
Taiwan
Contacts
CONTACTYi-Shan Sung
CONTACTShao-Yu Tsai
PRINCIPAL_INVESTIGATORShao-Yu Tsai
National Taiwan University
Outcome results
None listed