Extended-Release Melatonin in Patients With Rapid Eye Movement Sleep Behavior Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized, Double-Blind, Cross-Over Study Comparing the Efficacy of Immediate and Extended-Release Melatonin as a Supplement Affecting the Sleep Cycle in Patients With Parkinson Disease and Rapid Eye Movement Sleep Behavior Disorder

Conditions
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Rapid Eye Movement Sleep Behavior Disorder, Parkinson Disease

Intervention / Treatment
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* Dietary Supplement: Immediate Release Melatonin
* Dietary Supplement: Extended Release Melatonin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with Parkinson's disease and rapid eye movement sleep behavior disorder. Patient registered to Parkinson's disease database of Mayo Clinic Florida. Exclusion Criteria: Patients who are using other sleep aids or medications (Clonazepam). Patients who are not willing to undertake 1 week of washout period. Patients who do not sign a consent for research.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Release Melatonin, Then Extended Release Melatonin<br>Subjects will receive immediate release melatonin 5 mg orally at 9 pm every night for 4 weeks. After a washout period of 2 weeks, they then receive extended release melatonin 5 mg orally at 9 pm every night for 4 weeks. | Dietary Supplement: Immediate Release Melatonin<br>* 5 mg orally every night at 9 pm for 4 weeks<br>Dietary Supplement: Extended Release Melatonin<br>* 5 mg orally every night at 9 pm for 4 weeks<br>|
| Experimental: Extended Release Melatonin, Then Immediate Release Melatonin<br>Subjects will receive extended release melatonin 5 mg orally at 9 pm every night for 4 weeks. After a washout period of 2 weeks, they then receive immediate release melatonin 5 mg orally at 9 pm every night for 4 weeks. | Dietary Supplement: Immediate Release Melatonin<br>* 5 mg orally every night at 9 pm for 4 weeks<br>Dietary Supplement: Extended Release Melatonin<br>* 5 mg orally every night at 9 pm for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 4 weeks |