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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.
Participants in the intervention group will receive a standard pediatric neurology care plus a hybrid in-person and digital sleep education program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental intervention group | Experimental | standard pediatric neurology care plus a hybrid in-person and digital sleep education program |
|
| Usual care group | No Intervention | standard pediatric neurology care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinic-based and technology-supported sleep intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | At baseline and at 3, 6, and 12 months after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Onset Latency | Sleep onset latency is defined as the duration (minutes) from bedtime to actigraphy-derived sleep onset. | At baseline and at 3, 6, and 12 months after randomization. |
| Wake After Sleep Onset (WASO) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi-Shan Sung | Contact | +886223123456 | 288904 | yshansung33@ntu.edu.tw |
| Shao-Yu Tsai | Contact | +886223123456 | 262962 | stsai@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Shao-Yu Tsai | National Taiwan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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WASO is defined as the duration (minutes) scored as wake between sleep onset and final awakening.
| At baseline and at 3, 6, and 12 months after randomization. |
| Total Nighttime Sleep | Total nighttime sleep by actigraphy is defined as the total duration scored as sleep within the nocturnal rest interval. | At baseline and at 3, 6, and 12 months after randomization. |
| Daily 24-hour Sleep Duration | Daily 24-hour sleep duration is defined as the total duration scored as sleep. | At baseline and at 3, 6, and 12 months after randomization. |
| Children's Sleep Habits Questionnaire (CSHQ) | The CSHQ is a 45-item parent-reported questionnaire used to assess sleep behaviors in children. | At baseline and at 3, 6, and 12 months after randomization. |
| Child Behavior Checklist (CBCL) | CBCL is a parent-report instrument that evaluates behavioral and emotional problems in children. | At baseline and at 3, 6, and 12 months after randomization. |
| Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index (PSQI) is used to assess the overall sleep quality of parents, with higher scores indicating greater sleep disturbances. | At baseline and at 3, 6, and 12 months after randomization. |
| Center for Epidemiologic Studies Depression Scale | 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. | At baseline and at 3, 6, and 12 months after randomization. |