Sensing in Sleep Deep Brain Stimulation

NCT07636720 | Recruiting FDA Device

• 1 other identifier: STUDY00000600
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Dyssomnia; Parkinson's Disease and Parkinsonism

Keywords

Deep Brain Stimulation; Polysomnography; Sleep Disorders

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  Baseline to Day 14

Study Arms (2)

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

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.

Device: Polysomnography ON stimulation then OFF; Device: Polysomnography OFF stimulation then ON

Interventions

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.

Also known as: PSG OFF/ON

GPi-DBS Group; STN-DBS Group

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.

Also known as: PSG ON/OFF

GPi-DBS Group; STN-DBS Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

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

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Dyssomnias; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eleni O Vaou, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

• Pablo Coss, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleni O Vaou, MD

CONTACT

210 450 8048; vaou@uthscsa.edu

Omalys Biggs Rodriguez

CONTACT

210-450-7547; biggsrodrigu@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The subject will be randomized after completion of the baseline visit. This study will utilize block randomization with permuted blocks in a 1:1 ratio. Individuals will be assigned to either Group 1 or Group 2 after baseline assessment. The randomization will be predetermined, and the allocation will be concealed to the patient only.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This will be a single center, prospective, randomized cross over (On vs OFF) clinical trial

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: June 9, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared once the study is complete and data has been analyzed.

Locations

US (1)