Clinical trial Recruiting at 1 site Interventional Ages 40 to 80

Sleep and DBS: Testing Deep Brain Stimulation Effects on Sleep in Parkinson’s

Official title: Sensing in Sleep and Deep Brain Stimulation

Run by The University of Texas Health Science Center at San Antonio · NCT07636720 · Data updated 2026-11-12

This study tests how turning the Deep Brain Stimulation device on or off affects sleep quality in people with Parkinson’s who already have a DBS implant.

Quick facts

Study typeInterventional
Ages40 Years to 80 Years
SexAll
Enrollment20 (estimated)
SponsorThe University of Texas Health Science Center at San Antonio
Academic / other
Locations1 site (San Antonio, Texas)
StatusRecruiting
StartedFebruary 27, 2026
Main results expectedFebruary 1, 2028
Study endsFebruary 1, 2028
Registry record updatedJune 9, 2026
Trial IDNCT07636720 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 40–80 with idiopathic Parkinson’s disease who have a STN or GPi DBS implant (Percept RC) and can complete overnight sleep labs.

Probably not a fit

Patients who cannot tolerate stopping sleep medications for a washout or who have uncontrolled sleep apnea or other major sleep disorders may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with Parkinson’s and a Percept RC DBS device will sleep in a lab for two nights, one with stimulation on and one with stimulation off, to see how DBS influences sleep stages and events. The study uses Brainsense tools to link brain signals from STN and GPi to sleep patterns and to identify potential sleep biomarkers. By comparing on vs off sleep data, researchers aim to understand DBS’s impact on sleep quality and wakefulness beyond motor symptoms. This could also help guide future DBS programming to improve sleep and overall well-being in Parkinson’s patients.

Why it matters

Potential benefit: If successful, the study could lead to DBS settings that improve sleep quality for people with Parkinson’s.

How similar studies have gone: Previous work in neuromodulation has explored DBS and sleep, but this study’s direct on/off overnight design with sensing tools is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • The University of Texas Health Science Center at San Antonio - Brain Health Center
    San Antonio, Texas, United States
    Recruiting

Study contacts

  • Principal investigator: Eleni O Vaou, MD — The University of Texas Health Science Center at San Antonio
  • Study coordinator: Eleni O Vaou, MD
  • Email: vaou@uthscsa.edu
  • Phone: 210 450 8048

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.