Polysomnography ON stimulation the… for Parkinson's (NCT07636720)
Brain stimulation improves sleep quality
- Trial ID
- NCT07636720
- Official Title
- Sensing in Sleep and Deep Brain Stimulation
- Goal
- Brain stimulation improves sleep quality
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Study Type
- INTERVENTIONAL
- Enrollment
- 20 participants
- Conditions
- Parkinson's Disease and Parkinsonism, Dyssomnia
- Interventions
- Polysomnography ON stimulation then OFF, Polysomnography OFF stimulation then ON
Summary For Families
The goal is to understand how deep brain stimulation affects sleep problems in people with Parkinson's, including poor sleep quality, frequent awakenings, and acting-out dreams. Participants who already have the Percept RC deep brain stimulation device will spend two nights in a sleep lab, one with stimulation on and one with it off, while the device’s built-in sensing tools called Brainsense record brain signals from the areas where the contacts sit and those recordings are matched with standard overnight sleep monitoring. The study is looking for adults 40 to 80 with a Parkinson’s diagnosis who already have that implanted device, who score 23 or higher on a brief cognitive test, are willing to stop sleep sedatives for a short washout and turn the stimulator off for one night, and who do not have untreated sleep apnea, dementia, other major brain disorders, recent changes in Parkinson’s medications, or severe heart disease.
Locations
- The University of Texas Health Science Center at San Antonio - Brain Health Center, San Antonio, Texas, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Polysomnography ON stimulation then OFF. The goal is to understand how deep brain stimulation affects sleep problems in people with Parkinson's, including poor sleep quality, frequent awakenings, and acting-out dreams. Participants who already have the Percept RC deep brain stimulation device will spend two nights in a sleep lab, one with stimulation on and one with it off, while the device’s built-in sensing tools called Brainsense record brain signals from the areas where the contacts sit and those recordings are matched with standard overnight sleep monitoring. The study is looking for adults 40 to 80 with a Parkinson’s diagnosis who already have that implanted device, who score 23 or higher on a brief cognitive test, are willing to stop sleep sedatives for a short washout and turn the stimulator off for one night, and who do not have untreated sleep apnea, dementia, other major brain disorders, recent changes in Parkinson’s medications, or severe heart disease.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 1 year and 11 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. Ask the coordinator for the exact sequence and how long each phase lasts.
- How many visits does this trial involve?
- You will sleep overnight in the study sleep lab for two nights.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.
- Is there a medication washout in this trial?
- You must be willing to stop sleep hypnotics such as benzodiazepines and Ambien with a 3 day washout period.