Study Stopped
Slow enrollment
Extended-Release Melatonin in Patients With Rapid Eye Movement Sleep Behavior Disorder
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
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2022
CompletedFirst Posted
Study publicly available on registry
April 1, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedMay 29, 2024
May 1, 2024
1.8 years
March 23, 2022
May 28, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Immediate Release Melatonin, Then Extended Release Melatonin
EXPERIMENTALSubjects 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.
Extended Release Melatonin, Then Immediate Release Melatonin
EXPERIMENTALSubjects 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.
Interventions
5 mg orally every night at 9 pm for 4 weeks
5 mg orally every night at 9 pm for 4 weeks
Eligibility Criteria
You may qualify if:
- Diagnosed with Parkinson's disease and rapid eye movement sleep behavior disorder.
- Patient registered to Parkinson's disease database of Mayo Clinic Florida.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emir Festic, MD, MS
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 23, 2022
First Posted
April 1, 2022
Study Start
May 1, 2022
Primary Completion
February 1, 2024
Study Completion
February 1, 2024
Last Updated
May 29, 2024
Record last verified: 2024-05