Parkinson's Disease and ParkinsonismNCT07636720
Sensing in Sleep Deep Brain Stimulation
A study testing Polysomnography ON stimulation then OFF and Polysomnography OFF stimulation then ON in people with Parkinson's Disease and Parkinsonism and Dyssomnia, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson's Disease and Parkinsonism, Dyssomnia
- What is being tested?
- Polysomnography ON stimulation then OFF and Polysomnography OFF stimulation then ON
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Males and females; Age 40-80
- 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).
- Willingness to adhere to the PSG regimen and turn DBS off for one night.
- A score of ≥23 on the Montreal Cognitive Assessment (MoCA)
- Be willing to stop any sleep hypnotics such as benzodiazepines and Ambien, with a 3 day washout period.
Who cannot join
- History of severe cardiovascular disease, untreated obstructive sleep apnea (OSA).
- 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.
- History of Dementia.
- Report dopaminergic medication changes in the past month.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at San Antonio - Brain Health Center
San Antonio, Texas, 78229
Omalys Biggs Rodriguez, 210-450-8456, biggsrodrigu@uthscsa.edu
Eleni O Vaou, MD, 210-450 8048, vaou@uthscsa.edu
About this study
Official title: Sensing in Sleep and Deep Brain Stimulation
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.
- Conditions
- Parkinson's Disease and Parkinsonism, Dyssomnia
- Being tested
- Polysomnography ON stimulation then OFF, Polysomnography OFF stimulation then ON
- Keywords
- Deep Brain Stimulation, Polysomnography, Sleep Disorders
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Dyssomnias, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysomnography ON stimulation then OFFDevice
Also called PSG ON/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 ONDevice
Also called PSG OFF/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.
| Study group | Role | What they receive |
|---|---|---|
| STN-DBS Group | Experimental | Participants diagnosed with Parkinson's Disease who have subthalamic nucleus (STN) deep brain stimulation as a primary target for their condition Receives: Device: Polysomnography ON stimulation then OFF; Device: Polysomnography OFF stimulation then ON |
| GPi-DBS Group | Experimental | Participants diagnosed with Parkinson's Disease who have Globus Pallidus internus (GPi) deep brain stimulation as a primary target for their condition. Receives: Device: Polysomnography ON stimulation then OFF; Device: Polysomnography OFF stimulation then ON |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 to Day 14
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.
Measured: Baseline to Day 14
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.
Measured: Baseline to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start27 Feb 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease and ParkinsonismStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This will be a single center, prospective, randomized cross over (On vs OFF) clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eleni Vaou, The University of Texas Health Science Center at San Antonio
- Investigators
- Eleni O Vaou, MD, Principal investigator, The University of Texas Health Science Center at San AntonioPablo Coss, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636720
- Sponsor's protocol ID
- STUDY00000600
- Status last verified
- Jun 2026
- First submitted
- 6 Apr 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensing in Sleep and Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT07636720
- Acronym / sponsor ID
- STUDY00000600
- Conditions
- Parkinson's Disease and Parkinsonism, Dyssomnia
- Keywords
- Deep Brain Stimulation, Polysomnography, Sleep Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This will be a single center, prospective, randomized cross over (On vs OFF) clinical trial
| Arm | Type | Receives |
|---|---|---|
| STN-DBS Group | Experimental | Device: Polysomnography ON stimulation then OFF, Device: Polysomnography OFF stimulation then ONParticipants diagnosed with Parkinson's Disease who have subthalamic nucleus (STN) deep brain stimulation as a primary target for their condition |
| GPi-DBS Group | Experimental | Device: Polysomnography ON stimulation then OFF, Device: Polysomnography OFF stimulation then ONParticipants diagnosed with Parkinson's Disease who have Globus Pallidus internus (GPi) deep brain stimulation as a primary target for their condition. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability of subject to understand and the willingness to sign a written informed consent document.
- Males and females; Age 40-80
- 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).
- Willingness to adhere to the PSG regimen and turn DBS off for one night.
- A score of ≥23 on the Montreal Cognitive Assessment (MoCA)
Key exclusion criteria (4 listed)
- History of severe cardiovascular disease, untreated obstructive sleep apnea (OSA).
- 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.
- History of Dementia.
- Report dopaminergic medication changes in the past month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polysomnography ON stimulation then OFFAlso: PSG ON/OFFPatients 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. | Device | GPi-DBS Group, STN-DBS Group |
| Polysomnography OFF stimulation then ONAlso: PSG OFF/ONPatients 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. | Device | GPi-DBS Group, STN-DBS Group |
Primary outcome
Sensing & Sleep: Parkinson's Disease Sleep Assessment
Time frame: Day 1 to Day 14
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
Motor severity
Time frame: Baseline to Day 14
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.
Epworth Sleepiness Scale (ESS)
Time frame: Baseline to Day 14
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography ON stimulation then OFF and Polysomnography OFF stimulation then ON in people with Parkinson's Disease and Parkinsonism and Dyssomnia, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleni O Vaou, MD (210 450 8048, vaou@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensing & Sleep: Parkinson's Disease Sleep Assessment (time frame: Day 1 to Day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.