ClinicalTrials.gg
RecruitingNCT07636720Updated Jun 9, 2026

Sensing in Sleep Deep Brain Stimulation

An interventional study of Polysomnography ON stimulation then OFF and Polysomnography OFF stimulation then ON in Parkinson's Disease and Parkinsonism and Dyssomnia, sponsored by The University of Texas Health Science Center at San Antonio. Recruiting at 1 site in United States. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-09.

Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Feb 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 1,649 studies in Parkinson Disease with a site in United States — 304 open to participants now, 387 under way, 7 of them phase 3. Parkinson Disease · United States.

Planned enrollment
835th of 1,256
20 · median 36
Started
2026
with 82 others
No phase
585 of 1,649
146 open now
Primary completion
2028-02
later than 257 of 384 live
Registered
1,597th of 1,649
by date

Among the 1,649 studies in Parkinson Disease with a site in United States, this one is the 835th largest by planned enrollment of the 1,256 interventional ones that give a count, is one of 83 that started in 2026, is one of 585 with no phase, reaches primary completion later than 257 of the 384 other live ones, and was the 1,597th registered.

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

Browse Parkinson Disease studies →

Open to participants now

304 of the 1,649 studies in Parkinson Disease with a site in United States are open now. Recruiting first, the newest first:

299 more — sign in →

All 304 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.

This study: 40 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study 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.

Read the detailed description

This prospective study will use the Percept sensing tools, collectively referred to as Brainsense, to correlate STN and GPi-LFP activity to sleep stages, characterize sleep events and evaluate the effects of DBS stimulation on sleep quality and sleep events. This study may help identify and validate novel biomarkers to assess sleep quality, REM behavior disorder,sleep fragmentation, and awakenings in patients with Parkinson's Disease, which will support overall DBS' efficacy beyond motor symptoms, and supplement interventions to improve sleep, and potentially also guide more effective DBS programming.

03

Conditions studied

  • Parkinson's Disease and Parkinsonism
  • Dyssomnia

Keywords

  • Deep Brain Stimulation
  • Polysomnography
  • Sleep Disorders
04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Ability of subject to understand and the willingness to sign a written 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 (MoCA)
  6. Be willing to stop any sleep hypnotics such as benzodiazepines and Ambien, with a 3 day .

Exclusion criteria

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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study 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

    Device: Polysomnography ON stimulation then OFF · Device: Polysomnography OFF stimulation then ON

  • 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.

    Device: Polysomnography ON stimulation then OFF · Device: Polysomnography OFF stimulation then ON

Interventions

  • DevicePolysomnography 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.

    Also known as: PSG ON/OFF

  • DevicePolysomnography 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.

    Also known as: PSG OFF/ON

06

What researchers measure

Primary outcomes

  1. Sensing & Sleep: Parkinson's Disease Sleep Assessment

    A 7 item to rate sleep experience scored 0=unsure, 1=No and 2=Yes. Total range of scores is from 0-14 with a higher score indicating more issues with sleep

    Time frame: Day 1 to Day 14

  2. Motor severity

    Motor severity will be assessed by the Movement Disorders Society - Unified Parkinson's Disease Rating Scale - part III. This scale is the gold standard for measuring the severity and progression of PD. Part III entails motor examination which consists of 18 questions that are scored on a 0-4 scale. Higher scores suggest greater severity and progressing disease.

    Time frame: Baseline to Day 14

  3. Epworth Sleepiness Scale (ESS)

    The ESS is a short, self-administered survey that asks respondents to rate their likelihood of dozing off in eight different situations on a scale of 0-3. The total score ranges from 0-24, and is used to estimate if the respondent has excessive daytime sleepiness that may require medical attention. A score over 10 is abnormal. Higher scores suggest greater severity of daytime sleepiness.

    Time frame: Baseline to Day 14

07

Study locations

1 of 1 sites recruiting
  • The University of Texas Health Science Center at San Antonio - Brain Health Center
    San Antonio, Texas 78229, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All de-identified individual participant data will be shared with colleagues and in a peer review journal once analyzed and ready for publication. Summary results will be shared on ClinicalTrials.gov.

Supporting information: Study protocol, Statistical analysis plan

Time frame: Data will be shared once the study is complete and data has been analyzed.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Feb 2028, 23 months after the start.

Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 23 months is close to that.

Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 6, 2026
First posted
Jun 9, 2026
StartActual
Feb 27, 2026
Primary completionEst.
Feb 1, 2028
CompletionEst.
Feb 1, 2028
Last update
Jun 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07636720
Responsible party
Eleni Vaou (Associate Professor, The University of Texas Health Science Center at San Antonio) — Principal investigator
First posted
Jun 9, 2026
Start date
Feb 27, 2026
Primary completion
Feb 1, 2028 (estimated)
Completion
Feb 1, 2028 (estimated)
Last update
Jun 9, 2026

Study contacts

Eleni O Vaou, MD
Contact
vaou@uthscsa.edu
210 450 8048
Omalys Biggs Rodriguez
Contact
biggsrodrigu@uthscsa.edu
210-450-7547
Eleni O Vaou, MD
principal investigator · The University of Texas Health Science Center at San Antonio
Pablo Coss, MD
principal investigator · The University of Texas Health Science Center at San Antonio

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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