NCT05307770

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rapid Eye Movement Sleep Behavior Disorder
• Parkinson Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Immediate Release Melatonin	5 mg orally every night at 9 pm for 4 weeks
DIETARY_SUPPLEMENT	Extended Release Melatonin	5 mg orally every night at 9 pm for 4 weeks

Timeline

• Start date: 2022-05-01
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2022-04-01
• Last updated: 2024-05-29

Locations

1 site across 1 country: United States