Study to Determine Whether Ramelteon Helps People With REM Sleep Behavior Disorder

Sleep Medicine Centers of WNY20 enrolled

Overview

The purpose of this study is to determine whether the use of the drug ramelteon decreases the symptoms of REM Sleep Behavior Disorder.

This is a randomized double blind placebo controlled study to determine whether the use of ramelteon decreases symptoms of RBD. Outcome measures are determined by change in RBD polysomnographic score and assessment scores on the RBD symptom questionnaire and sleep diary.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

REM Sleep Behavior Disorder

Interventions

ramelteonDRUG

8 mg nightly for 30 nights

placeboDRUG

placebo control i pill nightly for 30 nights

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Meets criteria for RBD as determined by screening PSG's * steady bed partner for completion of RBD questionnaire Exclusion Criteria: * Hepatic impairment * RBD associated with narcolepsy * use of fluvoxamine, rifampin, fluconazole or ketoconazole * current alcohol or drug abuse

Locations (1)

Sleep Medicine Centers of WNY

West Seneca, New York, United States

Outcomes

Primary Outcomes

Change in polysomnographic scores

Time frame: 30 days

Secondary Outcomes

change in RBD symptom questionnaire and sleep diary

Time frame: 30 days

Data from ClinicalTrials.gov

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