Efficacy and Safety of Melatonin and Clonazepam for IRBD

Study Overview
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Brief Summary
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This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and polysomnographic parameters in patients with idiopathic REM sleep behavior disorder.

Detailed Description
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This study is open-label parallel trial with 4 weeks treatment with slow-release melatonin (Circadin) or with clonazepam (Rivotril). Polysomnography, symptom diary and questionnaire (Clinical Global Impression, RBDQ-HK, PSQI, ESS, SSS, ISI, BDI-II) will be performed before and after 4 weeks of each medications.

Official Title
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Efficacy and Safety of Melatonin and Rivotril Treatment for Idiopathic Rapid Eye Movement Sleep Disorder: Prospective Randomized Study.

Conditions
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REM Sleep Behavior Disorder

Intervention / Treatment
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* Drug: Melatonin 2mg
* Drug: ClonazePAM 0.5 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: REM sleep behavior disorder (ICSD-3 criteria) Exclusion Criteria: Neurological disorder including epilepsy or stroke History of psychiatric illness Neurodegenerative disease including dementia or parkinsonism. Medication affecting sleep within 1 month Intake of melatonin or clonazepam within 1 week. Unable to complete questionnaires

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Randomized Open-label study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Melatonin 2mg<br>4 weeks of 2mg of prolonged release Melatonin | Drug: Melatonin 2mg<br>* 4 weeks of 2mg prolonged release melatonin (Circadin)<br>* Other names: Circadin;|
| Placebo Comparator: ClonazePAM 0.5 MG<br>4 weeks of 0.5mg of rivotril | Drug: ClonazePAM 0.5 MG<br>* 4 weeks of 0.5mg clonazepam (Rivotril)<br>* Other names: Rivotril;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Automated REM without atonia index | Percentage seconds with chin EMG amplitude<1uV/ Total REM seconds. | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression of RBD symptom severity | Clinical Global Impression scale score provided by patient and caregiver. | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg | 
| REM sleep behavior disorder symptom severity | REM sleep behavior disorder questionnaire-Hong Kong total score | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg | 
| Sleep quality | Pittsburg Sleep Quality Index total score | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg | 
| Depression | Beck depression inventory-II total score | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clonazepam, Melatonin, Treatment, REM Sleep Behavior Disorder