Epilepsy in Children
Conditions
Brief summary
The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.
Detailed description
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.
Interventions
DRUGMelatonin
Melatonin 2 mg daily for 4 weeks
DRUGPlacebo
Placebo daily for 4 weeks
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
\- Children aged between 1 and 18 years with a confirmed diagnosis of epilepsy and with sleep problems
Exclusion criteria
* Children who are bedridden with limited mobility * Children with liver or kidney dysfunction * Children on hypnotics, antidepressants, or anxiolytics within 4 weeks before the baseline clinic visit * Adolescent girls who are pregnant or breastfeeding * Adolescent girls who have sexual activities but cannot take effective contraceptive measures during the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Onset Latency | 4 weeks | Sleep onset latency was assessed by actigraphy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Children's Sleep Disturbance | 4 weeks | 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 73 |
| 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. | 74 |
| Total | 147 |
Baseline characteristics
| Characteristic | Placebo, Then Melatonin | Melatonin, Then Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 74 Participants | 73 Participants | 147 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Taiwan | 74 participants | 73 participants | 147 participants |
| Sex: Female, Male Female | 34 Participants | 34 Participants | 68 Participants |
| Sex: Female, Male Male | 40 Participants | 39 Participants | 79 Participants |
| Sleep Onset Latency | 29.65 minutes STANDARD_DEVIATION 21.75 | 32.02 minutes STANDARD_DEVIATION 22.06 | 30.83 minutes STANDARD_DEVIATION 21.84 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 137 | 0 / 138 |
| other Total, other adverse events | 3 / 137 | 3 / 138 |
| serious Total, serious adverse events | 0 / 137 | 0 / 138 |
Outcome results
Primary
Sleep Onset Latency
Sleep onset latency was assessed by actigraphy.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Melatonin | Sleep Onset Latency | 22.80 minutes | Standard Deviation 16.21 |
| Placebo | Sleep Onset Latency | 29.99 minutes | Standard Deviation 29.74 |
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.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Melatonin | Children's Sleep Disturbance | 48.21 score on a scale | Standard Deviation 6.71 |
| Placebo | Children's Sleep Disturbance | 49.41 score on a scale | Standard Deviation 7.76 |