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Sensing in Sleep Deep Brain Stimulation

RecruitingNA

Sponsor: The University of Texas Health Science Center at San Antonio

Conditions: Parkinson's Disease and Parkinsonism, Dyssomnia

Interventions: Polysomnography ON stimulation then OFF, Polysomnography OFF stimulation then ON

Countries: United States

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 overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Ability of subject to understand and the willingness to sign a written informed consent document.
2. Males and females; Age 40-80
3. 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).
4. Willingness to adhere to the PSG regimen and turn DBS off for one night.
5. A score of ≥23 on the Montreal Cognitive Assessment (MoCA)
6. Be willing to stop any sleep hypnotics such as benzodiazepines and Ambien, with a 3 day washout period.

Exclusion Criteria:

1. History of severe cardiovascular disease, untreated obstructive sleep apnea (OSA).
2. 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.
3. History of Dementia.
4. Report dopaminergic medication changes in the past month.

Locations (1)

San Antonio, Texas, United States