Clinical Trial: Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic REM Sleep Behavior Disorder: a Pilot Study
Brief Summary: To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.
Detailed Summary: 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.
Sponsor: Seoul National University Hospital
Current Primary Outcome:
- Changes 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Sleep quality questionnaire [ Time Frame: after taking the treatment for 4 weeks ]PSQI
- Sleepiness questionnaire [ Time Frame: after taking the treatment for 4 weeks ]Epworth sleepiness scale
- Quality of life questionnaire [ Time Frame: after taking the treatment for 4 weeks ]SF-36 version 2.
- Changes in Dream enactment behavior frequency described in sleep diary [ Time Frame: Baseline and 4 weeks ]
- Drug adverse effect [ Time Frame: 4 weeks ]adverse events and reason for drug withdrawal
Original Secondary Outcome: Same as current
Information By: Seoul National University Hospital
Dates:
Date Received: July 13, 2016
Date Started: January 2016
Date Completion: December 31, 2017
Last Updated: April 26, 2017
Last Verified: April 2017