Back to resultsExtended-Release Melatonin in Patients With Rapid Eye Movement Sleep Behavior Disorder
Primary Purpose
Rapid Eye Movement Sleep Behavior Disorder, Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediate Release Melatonin
Extended Release Melatonin
Sponsored by
About this trial
This is an interventional supportive care trial for Rapid Eye Movement Sleep Behavior Disorder
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic FloridaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Immediate Release Melatonin, Then Extended Release Melatonin
Extended Release Melatonin, Then Immediate Release Melatonin
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05307770
Brief Title
Extended-Release Melatonin in Patients With Rapid Eye Movement Sleep Behavior Disorder
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rapid Eye Movement Sleep Behavior Disorder, Parkinson Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immediate Release Melatonin, Then Extended Release Melatonin
Arm Type
Experimental
Arm Description
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.
Arm Title
Extended Release Melatonin, Then Immediate Release Melatonin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Immediate Release Melatonin
Intervention Description
5 mg orally every night at 9 pm for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Extended Release Melatonin
Intervention Description
5 mg orally every night at 9 pm for 4 weeks
Primary Outcome Measure Information:
Title
Change in sleep cycle
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Mendiola
Phone
904-953-5064
Email
mendiola.michael@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Torsak Vimoktayon
Phone
904-953-3238
Email
vimoktayon.torsak@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emir Festic, MD, MS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Extended-Release Melatonin in Patients With Rapid Eye Movement Sleep Behavior Disorder
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