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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05307770
• Other study ID #: 21-003326
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Parkinson Disease
• Rapid Eye Movement Sleep Behavior Disorder
• REM Sleep Behavior Disorder

Intervention

Dietary Supplement:
• Immediate Release Melatonin
5 mg orally every night at 9 pm for 4 weeks
• Extended Release Melatonin
5 mg orally every night at 9 pm for 4 weeks

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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