Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study

Study Overview
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Brief Summary
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To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.

Detailed Description
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Investigators planned to administer low (2mg) and high (6mg) dose slow-release melatonin and the placebo for 4 weeks and evaluate Clinical Global Impression scale, RBD questionnaire, PSQI, Epworth sleepiness scale, and quality of life questionnaire (SF-36v2) before and after the treatment along with possible side effects and drug compliance.

Official Title
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Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic REM Sleep Behavior Disorder: a Pilot Study

Conditions
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REM Sleep Behavior Disorder

Intervention / Treatment
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* Drug: Circadin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: REM sleep behavior disorder according to ICSD-3 criteria No cognitive deficit or symptom of Parkinsonism Those with written consent. Exclusion Criteria: who took medication (ex. clonazepam) for REM sleep behavior disorder with degenerative neurologic disorder (ex. Parkinson's disease, Multiple System Atrophy, Lewy-body dementia, etc.) who took medication that can affect REM sleep behavior disorder (anti-depressant: SSRI, TCA, MAO-inhibitor) who is unable to answer questionnaires who have hypersensitive reaction to medications Pregnant women or breastfeeding who are diagnosed with other parasomnia disorder with severe medical disorder (severe liver failure, respiratory failure, heart failure, malignant tumor, etc.)

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Circadin 2mg<br>low-dose (2mg) slow-release melatonin for 1 month. | Drug: Circadin<br>* Slow-release melatonin<br>* Other names: slow-release melatonin;|
| Experimental: Circadin 6mg<br>high-dose (6mg) slow-release melatonin for 1 month. | Drug: Circadin<br>* Slow-release melatonin<br>* Other names: slow-release melatonin;|
| Placebo Comparator: Placebo<br>Administer placebo pills with identical morphology | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Clinical Global Impression scale |  | baseline and 4 weeks | 
| Changes in RBDQ-HK score (RBD questionnaire-HK) |  | Baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality questionnaire | PSQI | after taking the treatment for 4 weeks | 
| Sleepiness questionnaire | Epworth sleepiness scale | after taking the treatment for 4 weeks | 
| Quality of life questionnaire | SF-36 version 2. | after taking the treatment for 4 weeks | 
| Changes in Dream enactment behavior frequency described in sleep diary |  | Baseline and 4 weeks | 
| Drug adverse effect | adverse events and reason for drug withdrawal | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melatonin, REM sleep behavior disorder