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

Mayo Clinic

Status: Terminated

Conditions: Parkinson Disease; Rapid Eye Movement Sleep Behavior Disorder

Treatments: Dietary Supplement: Extended Release Melatonin; Dietary Supplement: Immediate Release Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT05307770

21-003326

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Immediate Release Melatonin, Then Extended Release Melatonin

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Extended Release Melatonin

Dietary Supplement: Immediate Release Melatonin

Extended Release Melatonin, Then Immediate Release Melatonin

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Extended Release Melatonin

Dietary Supplement: Immediate Release Melatonin