Pimavanserin for Sleep in Parkinson Disease
- Registration Number
- NCT05796167
- Lead Sponsor
- State University of New York - Downstate Medical Center
- Brief Summary
This pilot, self-control study is for patients with Parkinson's Disease (PD) psychosis (e.g., visual hallucinations, delusions) and sleep problems.
- Detailed Description
This is a feasibility study to determine whether pimavanserin improves sleep quality in patients with PD and visual hallucinations/delusions.
Patients will complete a Screening Visit to assess eligibility to participate in the study.
For more information, please contact Sofya Glazman, a study coordinator, at sofya.glazman@downstate.edu
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pimavanserin (Nuplazid) Pimavanserin Pimavanserin (Nuplazid) 34 mg oral capsules once a day for 6 weeks for patients with Parkinson disease psychosis (e.g., visual hallucinations, delusions) and sleep problems
- Primary Outcome Measures
Name Time Method Effect of pimavanserin on sleep fragmentation 6 weeks Number of arousals and the arousal index (arousals per hour of sleep) measured on polysomnography
- Secondary Outcome Measures
Name Time Method Effect of pimavanserin on sleep efficiency 6 weeks Sleep Efficiency Index in percent is the ratio of total sleep time (based on polysomnography recordings) to time in bed
Effect of pimavanserin on subjective measures of sleep 6 weeks PDSS-2 (Parkinson's Disease Sleep Scale Version 2) total score ranges from 0 (no disturbance) to 60 (maximum nocturnal disturbance). Scores \> 18 are considered as relevant sleep disturbances
Effect of pimavanserin on REM (Rapid Eye Movements) sleep behavior disorder 6 weeks Presence fo REM sleep without atonia (RWA) on polysomnograophy
Effect of pimavanserin on time in each sleep stage 6 weeks Time in each sleep stage as measured on polysomnography
Effect of pimavanserin on subjective measure of REM Sleep behavior disorder 6 weeks RBDSQ (REM (Rapid Eye Movements) Sleep Behavior Disorder Screening Questionnaire to assess the most prominent clinical features of RBD. It is a 10-item, patient self-rating instrument with short questions to be answered by either 'yes' or 'no'.
Effect of pimavanserin on sleep latency 6 weeks Time to first epoch on polysomnography
Effect of pimavanserin on total sleep time 6 weeks Total sleep time measured on polysomnography
Effect of pimavanserin on subjective measures of fatigue 6 weeks PFS-16 (Parkinson's disease Fatigue Scale): 16-item scale with the following scoring for each item: strong disagree -1, disagree - 2, neither agree or disagree - 3, agree - 4, strongly agree - 5; with overall score of ≥8 indicates the presence of significant fatigue.
Trial Locations
- Locations (1)
SUNY Downstate Health Sciences University
🇺🇸Brooklyn, New York, United States