To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Seoul National University Hospital
Seoul, South Korea
RECRUITINGChanges in Clinical Global Impression scale
Time frame: baseline and 4 weeks
Changes in RBDQ-HK score (RBD questionnaire-HK)
Time frame: Baseline and 4 weeks
Sleep quality questionnaire
PSQI
Time frame: after taking the treatment for 4 weeks
Sleepiness questionnaire
Epworth sleepiness scale
Time frame: after taking the treatment for 4 weeks
Quality of life questionnaire
SF-36 version 2.
Time frame: after taking the treatment for 4 weeks
Changes in Dream enactment behavior frequency described in sleep diary
Time frame: Baseline and 4 weeks
Drug adverse effect
adverse events and reason for drug withdrawal
Time frame: 4 weeks
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