REM Sleep Behavior Disorder
Conditions
Keywords
Clonazepam, Melatonin, Treatment, REM Sleep Behavior Disorder
Brief summary
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
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.
Interventions
DRUGMelatonin 2mg
4 weeks of 2mg prolonged release melatonin (Circadin)
4 weeks of 0.5mg clonazepam (Rivotril)
Sponsors
Kyung Hee University Hospital at Gangdong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Mask treatment arm when analyzing polysomnography.
Intervention model description
Prospective Randomized Open-label study
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Automated REM without atonia index | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg | Percentage seconds with chin EMG amplitude\<1uV/ Total REM seconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression of RBD symptom severity | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg | Clinical Global Impression scale score provided by patient and caregiver. |
| REM sleep behavior disorder symptom severity | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg | REM sleep behavior disorder questionnaire-Hong Kong total score |
| Sleep quality | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg | Pittsburg Sleep Quality Index total score |
| Depression | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg | Beck depression inventory-II total score |
Countries
South Korea
Outcome results
None listed