Sensing in Sleep Deep Brain Stimulation

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT07636720
Status
Recruiting
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Conditions

  • Dyssomnia
  • Parkinson's Disease and Parkinsonism

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Polysomnography ON stimulation then OFF — DEVICE
    Patients will undergo a 2-night Polysomnography (PSG). Stimulation will be set to "ON" stimulation for the 1st PSG night, then will cross over the 2nd PSG study night in the opposite stimulation state. Each subject will act as their own control.
  • Polysomnography OFF stimulation then ON — DEVICE
    Patients will undergo a 2-night Polysomnography (PSG). Stimulation will be set to "OFF" stimulation for the 1st PSG night, then will cross over the 2nd PSG study night in the opposite stimulation state. Each subject will act as their own control.

Study Details

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.

Key Dates

Start date
Feb 27, 2026
Status verified
Jun 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: STN-DBS Group
    Participants diagnosed with Parkinson's Disease who have subthalamic nucleus (STN) deep brain stimulation as a primary target for their condition
  • Experimental: GPi-DBS Group
    Participants diagnosed with Parkinson's Disease who have Globus Pallidus internus (GPi) deep brain stimulation as a primary target for their condition.

Primary Outcome Measure

Sensing & Sleep: Parkinson's Disease Sleep Assessment [ Time Frame: Day 1 to Day 14 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at San Antonio - Brain Health CenterSan AntonioTexas78229
Omalys Biggs Rodriguez
[email protected]
210-450-8456
Eleni O Vaou, MD
[email protected]
210-450 8048

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The University of Texas Health Science Center at San Antonio - Brain Health Center· San Antonio, TX

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