Pilot Study of Melatonin and Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Melatonin; Placebos
Intervention description: Sustained release formula (Brand: Jigsaw); dosage will be 9mg for all subjects. Taken 30 minutes prior to bedtime for four weeks.; Placebo. Taken 30 minutes prior to bedtime for four weeks.
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: epilepsy; sleep; seizures; cognition

Summary:

      The prevalence of epilepsy is 1% in the USA. About 30% of epilepsy patients eventually become
      refractory to medical treatment. Co morbid conditions are becoming as important as seizure
      control as these affect overall wellbeing. Sleep related complaints are frequent in them
      including, frequent arousals, difficulty falling asleep and excessive daytime sleepiness.
      Polysomnography shows increased arousal index, sleep onset latency, and stage shifts and
      fragmented REM sleep. Poor sleep efficiency causes daytime fatigue, poor cognition and
      behavior and can worsen seizure control. Stabilizing sleep may improve seizure control.
      Melatonin is a naturally occurring hormone in the body involved in the regulation of
      circadian rhythm and exogenously given, has been shown to decrease sleep onset latency,
      arousals, and there-by increase sleep efficiency in healthy pediatric patients. Similar data
      does not exist in the patients with epilepsy. As sleep has important impact on epilepsy and
      overall functioning, it is important to study effect of melatonin in children with epilepsy.

      We propose a randomized double blind placebo controlled trial with a cross-over design. Our
      hypothesis is that, for patients with epilepsy, administration of melatonin 30 minutes before
      bedtime for four weeks may:

        -  Improve the quality of sleep;

        -  Improve daytime functioning in terms of cognition, behavior and quality of life;

        -  Decrease epileptic potential. We will use polysomnography, electroencephalogram,
           psychomotor vigilance task, seizure diary, and questionnaires to assess the effect of
           melatonin on these domains. This study may help to improve the care of children with
           epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 6-11 years (prepubertal based on tanner staging)

          -  Patients with epilepsy (diagnosis based on ILAE).

          -  Normal intelligence based on school placement (defined as age appropriate; an IEP due
             to epilepsy related causes is acceptable as is placement in a higher grade) or IQ>70
             (testing done with in 12 months of enrollment)

          -  No history of significant snoring- loud snoring every night outside of a room with
             closed door

          -  Combined score of 30 or more on sleep fragmentation, parasomnia and daytime drowsiness
             subscales on SBQ.

        Exclusion Criteria:

          -  History of significant snoring- loud snoring every night heard outside of a room with
             closed door

          -  Diagnosis of obstructive sleep apnea (OSA) or periodic limb movement disorder on PSG

          -  Vagus nerve stimulator implanted

          -  History of a major psychiatric disease (e.g. psychosis, major depression)

          -  History of autism or pervasive development disorder

          -  Severe neuro-developmental disabilities, as determined by PI

          -  Clinically significant systemic organic disease, as determined by PI

          -  Current use of melatonin or sustained release melatonin

          -  Prior use of sustained release melatonin

          -  Current use of any hypnotic medications except for medications used as a rescue
             treatment for seizures

          -  Use of psychoactive or stimulant medication for attention deficit disorders

          -  Subjects with immune disorders, lympho-proliferative disorders, and those taking oral
             corticosteroids or other immuno-suppressants

          -  Subject or parent/legal guardian might not be reasonably expected to be compliant with
             or to complete the study.