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Extended-Release Melatonin for REM Sleep Behavior Disorder

N/A

Waitlist Available

Led By Emir Festic, MD, MS

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with Parkinson's disease and rapid eye movement sleep behavior disorder.

Be older than 18 years old

Must not have

Patients who are using other sleep aids or medications (Clonazepam).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of two types of melatonin supplements in people with Parkinson's disease and a sleep disorder.

Who is the study for?

This trial is for individuals with Parkinson's disease who also have REM Sleep Behavior Disorder and are listed in the Mayo Clinic Florida's Parkinson's database. It excludes those using other sleep aids like Clonazepam, unwilling to stop these medications for a week before starting the trial, or not consenting to research participation.

What is being tested?

The study aims to compare two forms of melatonin: immediate-release versus extended-release, to see which one better improves sleep in patients with Parkinson’s and REM Sleep Behavior Disorder.

What are the potential side effects?

Melatonin may cause drowsiness during daytime, mood changes, headaches, dizziness, stomach discomfort or cramps. These side effects can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have Parkinson's disease and a sleep disorder where I act out dreams.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently using sleep aids or medications like Clonazepam.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in sleep cycle

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Immediate Release Melatonin, Then Extended Release MelatoninExperimental Treatment2 Interventions

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.

Group II: Extended Release Melatonin, Then Immediate Release MelatoninExperimental Treatment2 Interventions

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.

0 / 2Eligibility criteria met