REM Sleep Behavior Disorder Clinical Trial
Official title:
Efficacy and Safety of Melatonin and Rivotril Treatment for Idiopathic Rapid Eye Movement Sleep Disorder: Prospective Randomized Study.
Verified date | February 2021 |
Source | Kyung Hee University Hospital at Gangdong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and polysomnographic parameters in patients with idiopathic REM sleep behavior disorder.
Status | Completed |
Enrollment | 34 |
Est. completion date | December 1, 2020 |
Est. primary completion date | December 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kyung Hee University Hospital at Gangdong | Seoul |
Lead Sponsor | Collaborator |
---|---|
Kyung Hee University Hospital at Gangdong |
Korea, Republic of,
Ferri R, Marelli S, Ferini-Strambi L, Oldani A, Colli F, Schenck CH, Zucconi M. An observational clinical and video-polysomnographic study of the effects of clonazepam in REM sleep behavior disorder. Sleep Med. 2013 Jan;14(1):24-9. doi: 10.1016/j.sleep.2012.09.009. Epub 2012 Oct 23. — View Citation
Iranzo A, Molinuevo JL, Santamaría J, Serradell M, Martí MJ, Valldeoriola F, Tolosa E. Rapid-eye-movement sleep behaviour disorder as an early marker for a neurodegenerative disorder: a descriptive study. Lancet Neurol. 2006 Jul;5(7):572-7. — View Citation
Kunz D, Mahlberg R. A two-part, double-blind, placebo-controlled trial of exogenous melatonin in REM sleep behaviour disorder. J Sleep Res. 2010 Dec;19(4):591-6. doi: 10.1111/j.1365-2869.2010.00848.x. — View Citation
McCarter SJ, Boswell CL, St Louis EK, Dueffert LG, Slocumb N, Boeve BF, Silber MH, Olson EJ, Tippmann-Peikert M. Treatment outcomes in REM sleep behavior disorder. Sleep Med. 2013 Mar;14(3):237-42. doi: 10.1016/j.sleep.2012.09.018. Epub 2013 Jan 23. — View Citation
McGrane IR, Leung JG, St Louis EK, Boeve BF. Melatonin therapy for REM sleep behavior disorder: a critical review of evidence. Sleep Med. 2015 Jan;16(1):19-26. doi: 10.1016/j.sleep.2014.09.011. Epub 2014 Oct 13. Review. — View Citation
Nardone R, Golaszewski S, Höller Y, Christova M, Trinka E, Brigo F. Neurophysiological insights into the pathophysiology of REM sleep behavior disorders: a review. Neurosci Res. 2013 Jul;76(3):106-12. doi: 10.1016/j.neures.2013.03.009. Epub 2013 Mar 28. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Sleep quality | Pittsburg Sleep Quality Index total score | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg | |
Secondary | Depression | Beck depression inventory-II total score | 4 weeks of prolonged release melatonin 2mg or clonazepam 0.5mg |
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