Sensing in Sleep Deep Brain Stimulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorThe University of Texas Health Science Center at San Antonio
About this trial
Participants in this study have Parkinson's Disease and already have a device, called the Percept RC Deep Brain Stimulation device implanted. People with Parkinson's disease often have issues related to sleep such as bad quality of sleep, waking up often and sleep apnea (breathing stops and starts during sleep).
For this study, participants will be sleeping overnight in the study sleep lab for two nights. One night, Deep Brain Stimulation (DBS) device turned on and one night with the DBS off, either in this order or the reverse.
Eligibility criteria
Qualifiers
Ability of subject to understand and the willingness to sign a written informed consent document.
Males and females; Age 40-80
Subjects 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 to subthalamic nucleus (STN) or Globus pallidus internus (GPi).
Willingness to adhere to the PSG regimen and turn DBS off for one night.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Polysomnography ON stimulation then OFF
- Polysomnography OFF stimulation then ON
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov