Polysomnography ON stimulation the… for Parkinson's (NCT07636720)
Does stimulation change sleep quality
- Trial ID
- NCT07636720
- Official Title
- Sensing in Sleep and Deep Brain Stimulation
- Goal
- Does stimulation change 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
Researchers are testing whether the implanted Percept RC deep brain stimulation device changes common sleep problems in Parkinson's, like poor sleep quality, frequent awakenings, and sleep apnea. Participants spend two nights in a sleep lab, one night with stimulation on and one night with it off, while standard sleep monitoring and the device's Brainsense recordings match brain signals from the sites where the leads sit to sleep stages and events. The team hopes to find brain-signal markers linked to sleep quality, REM behavior symptoms, sleep fragmentation, and awakenings, which could help guide better stimulation settings to improve sleep beyond movement benefits. The study is for people 40 to 80 years old with Parkinson's who already have a Percept RC implant in a typical target area, can give consent, do not have dementia, and are willing to stop certain sleep medicines and spend two nights in the sleep lab.
Locations
- The University of Texas Health Science Center at San Antonio - Brain Health Center, San Antonio, Texas, United States
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07636720. It is the one about "Does stimulation change sleep quality". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take? The listing already answers this: Participants will have two overnight in-person study visits (sleeping in the study sleep lab for two nights), one night with DBS on and one night with DBS off. Ask the coordinator to confirm it still applies.
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: 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.
- Would I need to stop or pause any of my current medications? The listing already answers this: Participants must be willing to stop any sleep hypnotics such as benzodiazepines and Ambien, with a 3 day washout period. Ask the coordinator to confirm it still applies.
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Polysomnography ON stimulation then OFF. Researchers are testing whether the implanted Percept RC deep brain stimulation device changes common sleep problems in Parkinson's, like poor sleep quality, frequent awakenings, and sleep apnea. Participants spend two nights in a sleep lab, one night with stimulation on and one night with it off, while standard sleep monitoring and the device's Brainsense recordings match brain signals from the sites where the leads sit to sleep stages and events. The team hopes to find brain-signal markers linked to sleep quality, REM behavior symptoms, sleep fragmentation, and awakenings, which could help guide better stimulation settings to improve sleep beyond movement benefits. The study is for people 40 to 80 years old with Parkinson's who already have a Percept RC implant in a typical target area, can give consent, do not have dementia, and are willing to stop certain sleep medicines and spend two nights in the sleep lab.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- 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?
- Participants will have two overnight in-person study visits (sleeping in the study sleep lab for two nights), one night with DBS on and one night with DBS off.
- 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?
- Participants must be willing to stop any sleep hypnotics such as benzodiazepines and Ambien, with a 3 day washout period.