Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT03377569
Eligibility Criteria:
Inclusion Criteria:
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:
1. Have a computer and be willing to use it as part of this study.
2. Be able to learn to use and maintain a wristband-style sleep monitor.
3. Turn off their Implantable Pulse Generator (IPG, implanted battery).
4. Wear a wristband-style sleep monitor for 3 weeks, 6 weeks prior to surgery.
5. Spend one overnight research stay in the UCH Sleep lab, 3 weeks prior to DBS surgery .
6. Spend one overnight research stay in the UCH Sleep lab, immediately prior to IPG surgery, to record brain activity from the DBS electrode .
7. Have a 15 minute surgery to externalize the DBS lead cable to allow overnight recordings to occur.
8. Be pseudo-randomized to one of 2 conditions: OFF stimulation or ON stimulation.
9. Wear a wristband-style sleep monitor for 3 weeks, 3 months post-DBS surgery, in one of the 2 pseudo-randomized conditions.
10. 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 Criteria:
1. Subjects with Parkinson's Disease (PD) who are not planning to have staged, bilateral deep brain stimulation surgery at the University of Colorado Hospital.
2. Subjects without a documented sleep disorder.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03377569
Study Brief:
Protocol Section:
NCT03377569