Recruiting

DBS

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT07636720

Conditions

Parkinson's Disease and Parkinsonism

Dyssomnia

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Polysomnography ON stimulation then OFF

Polysomnography OFF stimulation then ON

Study Details

Brief summary:

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.

Conditions

Parkinson's Disease and Parkinsonism

Dyssomnia

Study ID

NCT07636720

Start date

Feb 27, 2026

Status verified date

Jun, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Polysomnography ON stimulation then OFF

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

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.

Primary outcome measure

  • Sensing & Sleep: Parkinson's Disease Sleep Assessment [ Time Frame: Day 1 to Day 14 ]
  • Motor severity [ Time Frame: Baseline to Day 14 ]
  • Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline to Day 14 ]

Central Contacts and Locations

Central contacts

Eleni O Vaou, MD

210 450 8048vaou@uthscsa.edu

Omalys Biggs Rodriguez

210-450-7547biggsrodrigu@uthscsa.edu

Locations

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

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Omalys Biggs Rodriguez

210-450-8456biggsrodrigu@uthscsa.edu

Eleni O Vaou, MD

210-450 8048vaou@uthscsa.edu

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Keywords

  • Deep Brain Stimulation
  • Polysomnography
  • Sleep Disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-06-09.