Clinical trial for Parkinson's Disease and Parkinsonism
Official title Sensing in Sleep Deep Brain Stimulation
ClinicalTrials.gov ID: NCT07636720
What this study is testing
- What it's testing
- The study wants to see how the deep brain stimulation device affects sleep quality and breathing during sleep in Parkinson's patients.
- Who it's for
- People with Parkinson's disease who already have a Percept RC deep brain stimulation device implanted.
- What's involved
- Participants will spend two nights in a sleep lab, sleeping one night with the device turned on and one night with it turned off. Their sleep will be monitored.
- Time commitment
- The study lasts two overnight visits to the sleep lab.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Males and females; Age 40-80
- people with the diagnosis of idiopathic PD consistent with the United Kingdom Parkinson Disease society brain bank criteria, or documented diagnosis...
- Willingness to adhere to the PSG regimen and turn DBS off for one night.
- A score of ≥23 on the Montreal Cognitive Assessment (MoCA)
You likely can't join if
- History of severe cardiovascular disease, untreated obstructive sleep apnea (OSA).
- History of other neurological disorders affecting the central nervous system such as stroke, multiple sclerosis, tumors, amyotrophic lateral...
- History of Dementia.
- Report dopaminergic medication changes in the past month.
See the full eligibility criteria
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Males and females; Age 40-80
- people with the diagnosis of idiopathic PD consistent with the United Kingdom Parkinson Disease society brain bank criteria, or documented diagnosis of Parkinson Disease who have a Deep Brain Implant, Percept RC device...
- Willingness to adhere to the PSG regimen and turn DBS off for one night.
- A score of ≥23 on the Montreal Cognitive Assessment (MoCA)
- Be willing to stop any sleep hypnotics such as benzodiazepines and Ambien, with a 3 day washout period.
- History of severe cardiovascular disease, untreated obstructive sleep apnea (OSA).
- History of other neurological disorders affecting the central nervous system such as stroke, multiple sclerosis, tumors, amyotrophic lateral sclerosis or muscle disease such as muscular dystrophy, myopathy.
- History of Dementia.
- Report dopaminergic medication changes in the past month.
The study team makes the final eligibility decision.
Where it is enrolling
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Antonio, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.