Extensive phenotyping of REM sleep behavior disorder in patients with Parkinson*s disease and Dementia with Lewy bodies - REMIND (REM-sleep In Neurological Disorders)

Vrije Universiteit Medisch Centrum0 个研究点目标入组 80 人开始时间: 待定最近更新: 2024年4月15日

试验速览

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•- Diagnosed with probable or possible DLB according to the McKeith diagnostic
•criteria or diagnosed with PD according to the Movement Disorder Society
•clinical diagnostic criteria for Parkinson*s disease. - Being able to read and
•understand Dutch
•- Being able to understand the aim of the study and the study procedure and
•give written informed consent
•- Absence of medication that is known to precipitate RSWA/RBD, particularly the
•antidepressants venlafaxine, serotonin-specific reuptake inhibitors (SSRIs),
•mirtazapine and other antidepressant agents (but not bupropion), and medication
•that is known to reduce RSWA (melatonin).
•- Signed statement of eligibility to participate from the treating specialist
•(e.g. neurologist)

•We will include 80 subjects in the final study; we expect that we will lose
•~20% during screening due to exclusion criteria listed below, and therefore
•expect to screen appr. 100 patients. All patients - A history of
•neurodegenerative disorders that affect the central nervous system other than
•PD or DLB - A contraindication to MRI (i.e. metal implants, cardiac pacemakers,
•prior exposition to metal flakes without an X-ray showing absence of embedded
•metal in the body, claustrophobia or feeling uncomfortable in small, enclosed
•spaces, being pregnant) - Patients who have received brain surgery for
•Parkinson*s disease - Unwillingness to be informed of unexpected medical
•findings After polysomnography - Untreated moderate to severe obstructive sleep
•apnea (AHI>=15/h) - None or insufficient amounts (< 5 min) of REM sleep
•during polysomnography

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