This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and polysomnographic parameters in patients with idiopathic REM sleep behavior disorder.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
34
4 weeks of 2mg prolonged release melatonin (Circadin)
4 weeks of 0.5mg clonazepam (Rivotril)
Kyung Hee University Hospital at Gangdong
Seoul, South Korea
Automated REM without atonia index
Percentage seconds with chin EMG amplitude\<1uV/ Total REM seconds.
Time frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Clinical Global Impression of RBD symptom severity
Clinical Global Impression scale score provided by patient and caregiver.
Time frame: 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
Time frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Sleep quality
Pittsburg Sleep Quality Index total score
Time frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
Depression
Beck depression inventory-II total score
Time frame: 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg
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