Parkinson Disease, Rapid Eye Movement Sleep Behavior Disorder
Conditions
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.
Interventions
DIETARY_SUPPLEMENTImmediate Release Melatonin
5 mg orally every night at 9 pm for 4 weeks
DIETARY_SUPPLEMENTExtended Release Melatonin
5 mg orally every night at 9 pm for 4 weeks
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed