The purpose of this research is to compare the efficacy of immediate versus extended-release melatonin as a supplement affecting the sleep cycle in patients with Parkinson disease and Rapid Eye Movement Sleep Behavior Disorder.
Enrolled patients with Parkinson disease and previously diagnosed rapid eye movement sleep behavior disorder, who are being treated at Mayo Clinic in Florida, will be randomized to receive either immediate-release melatonin or extended-release melatonin and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of 4 weeks separated by a washout period of 2 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
25
5 mg orally every night at 9 pm for 4 weeks
5 mg orally every night at 9 pm for 4 weeks
Mayo Clinic Florida
Jacksonville, Florida, United States
Change in sleep cycle
Assessed by the self-reported modified Mayo Sleep questionnaire (MSQ) which consists of 8 questions related to sleep behavior in the past month.
Time frame: Baseline and 4 weeks
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