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The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
Sleep disturbances are more prevalent in children with epilepsy whose sleep can be disrupted by seizures occurring during the night and/or during the day. Melatonin is a naturally occurring hormone produced in the pineal which regulates sleep-wake cycles and facilitates quality sleep. Therefore, the purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin | Experimental | Melatonin |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | Melatonin 2 mg daily for 4 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Onset Latency | Sleep onset latency was assessed by actigraphy. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Children's Sleep Disturbance | Children's sleep disturbance was assessed by Children's Sleep Habits Questionnaire (CSHQ) total sleep disturbance score. There are 33 questions sumed as total score, range between 33 to 99. Higher score indicated more sleep disturbance problems in children. | 4 weeks |
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Inclusion Criteria:
- Children aged between 1 and 18 years with a confirmed diagnosis of epilepsy and with sleep problems
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wang-Tso Lee | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 10051 | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Melatonin, Then Placebo | Participants first received melatonin (2 mg for children younger than 6 years or 4 mg for those 6 years and older) every night for 4 weeks. After a washout period of 2 weeks, they then received Placebo tablet each evening for 4 weeks. |
| FG001 | Placebo, Then Melatonin | Participants first received Placebo tablet every night for 4 weeks. After a washout period of 2 weeks, they then received Melatonin (2 mg for children younger than 6 years or 4 mg for those 6 years and older) every night for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (for 4 Weeks) |
| |||||||||||||
| Wash-out Period (for 2 Weeks) |
| |||||||||||||
| Second Intervention (for 4 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Melatonin, Then Placebo | Melatonin First then Placebo Participants first received melatonin (2 mg for children younger than 6 years or 4 mg for those 6 years and older) every night for 4 weeks. After a washout period of 2 weeks, they then received Placebo tablet each evening for 4 weeks. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Onset Latency | Sleep onset latency was assessed by actigraphy. | Posted | Mean | Standard Deviation | minutes | 4 weeks |
|
|
14 weeks
Six participants had a single non-serious adverse event each, evenly distributed between the melatonin (n=3) and placebo (n=3) groups. In the melatonin group, one participant reported mild hand weakness and decreased appetite. The other two participants in the melatonin group reported somnolence and fatigue. Adverse events in the placebo group included reported increased seizure frequency (n=1), body tremor (n=1), and agitation (n=1).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Melatonin | Melatonin Melatonin: Melatonin 2 mg daily for 4 weeks | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild hand weakness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shao-Yu Tsai | School of Nursing, College of Medicine, National Taiwan University, Taipei, Taiwan | (02)23123456#288904 | stsai@ntu.edu.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 18, 2025 | Jun 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D013213 | Starch |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo | Drug | Placebo daily for 4 weeks |
|
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| Placebo, Then Melatonin |
Placebo First then Melatonin Participants first received Placebo tablet every night for 4 weeks. After a washout period of 2 weeks, they then received Melatonin (2 mg for children younger than 6 years or 4 mg for those 6 years and older) every night for 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Sleep Onset Latency | Mean | Standard Deviation | minutes |
|
|
| Secondary | Children's Sleep Disturbance | Children's sleep disturbance was assessed by Children's Sleep Habits Questionnaire (CSHQ) total sleep disturbance score. There are 33 questions sumed as total score, range between 33 to 99. Higher score indicated more sleep disturbance problems in children. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
|
|
| 137 |
| 0 |
| 137 |
| 3 |
| 137 |
| EG001 | Placebo | Placebo Placebo: Placebo daily for 4 weeks | 0 | 138 | 0 | 138 | 3 | 138 |
| decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| somnolence and fatigue | Nervous system disorders | Systematic Assessment |
|
| increased seizure frequency | Nervous system disorders | Systematic Assessment |
|
| body tremors | Nervous system disorders | Systematic Assessment |
|
| agitation | Nervous system disorders | Systematic Assessment |
|
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| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |