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

Not Applicable

Terminated

• Conditions: Parkinson Disease; Rapid Eye Movement Sleep Behavior Disorder
• Interventions: Dietary Supplement: Immediate Release Melatonin; Dietary Supplement: Extended Release Melatonin

• Registration Number: NCT05307770
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-03-23
• Study First Posted: 2022-04-01
• Study Start: 2022-05-01
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Extended Release Melatonin, Then Immediate Release Melatonin	Immediate Release Melatonin	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.
Extended Release Melatonin, Then Immediate Release Melatonin	Extended Release Melatonin	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.
Immediate Release Melatonin, Then Extended Release Melatonin	Immediate Release Melatonin	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.
Immediate Release Melatonin, Then Extended Release Melatonin	Extended Release Melatonin	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.

Primary Outcome Measures

Name	Time	Method
Change in sleep cycle	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.

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States