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

  • End date
    Jun 3, 2023
  • participants needed
  • sponsor
    Mayo Clinic
Updated on 3 June 2022


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.

Condition Rapid Eye Movement Sleep Behavior Disorder, Parkinson Disease
Treatment Immediate Release Melatonin, Extended Release Melatonin
Clinical Study IdentifierNCT05307770
SponsorMayo Clinic
Last Modified on3 June 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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