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
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Mayo Clinic
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Change in sleep cycle
Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in sleep cycle
Time Frame: Baseline and 4 weeks
Assessed by the self-reported modified Mayo Sleep questionnaire (MSQ) which consists of 8 questions related to sleep behavior in the past month.
Secondary Outcomes
No secondary outcomes reported
Investigators
Emir Festic
Principal Investigator
Mayo Clinic