Status:
ACTIVE_NOT_RECRUITING
Subcortical Oscillations in Human Sleep Dysregulation
Lead Sponsor:
University of Colorado, Denver
Conditions:
Parkinson Disease
REM Behavior Disorder
Eligibility:
All Genders
18-80 years
Brief Summary
Sleep problems are common in the United States (US) adult population (\>50 million), and have a negative impact on quality of life, productivity, and healthcare. A major obstacle to understanding how ...
Detailed Description
Sleep is necessary for life; critically important to the regulation of body and brain function. Sleep problems are common in the U.S. adult population (\>50 million), and have a negative impact on qua...
Eligibility Criteria
Inclusion
- Subjects with Parkinson's Disease (PD) who are planning to have staged, bilateral deep brain stimulation surgery at the University of Colorado Hospital and willing and able to do the following:
- Have a computer and be willing to use it as part of this study.
- Be able to learn to use and maintain a wristband-style sleep monitor.
- Turn off their Implantable Pulse Generator (IPG, implanted battery).
- Wear a wristband-style sleep monitor for 3 weeks, 6 weeks prior to surgery.
- Spend one overnight research stay in the UCH Sleep lab, 3 weeks prior to DBS surgery .
- Spend one overnight research stay in the UCH Sleep lab, immediately prior to IPG surgery, to record brain activity from the DBS electrode .
- Have a 15 minute surgery to externalize the DBS lead cable to allow overnight recordings to occur.
- Be pseudo-randomized to one of 2 conditions: OFF stimulation or ON stimulation.
- Wear a wristband-style sleep monitor for 3 weeks, 3 months post-DBS surgery, in one of the 2 pseudo-randomized conditions.
- Spend one overnight research stay in the UCH Sleep lab, 4 months post DBS surgery, in one of the pseudo-randomized conditions.
- Subjects will have a sleep disorder documented in their medical history as determined by a single question screen for REM sleep behavior disorder.
Exclusion
- Subjects with Parkinson's Disease (PD) who are not planning to have staged, bilateral deep brain stimulation surgery at the University of Colorado Hospital.
- Subjects without a documented sleep disorder.
Key Trial Info
Start Date :
February 27 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03377569
Start Date
February 27 2018
End Date
December 1 2024
Last Update
May 13 2024
Active Locations (1)
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1
University of Colorado
Aurora, Colorado, United States, 80045