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NCT05070013 · ClinicalTrials.gov registry record · NA
Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease (Aim 2)
A NA study of Parkinson's Disease and Sleep Fragmentation, sponsored by University of Nebraska.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT05070013 is a NA study of Parkinson's Disease and Sleep Fragmentation that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 20 participants, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05070013, a NA study of Parkinson's Disease and Sleep Fragmentation, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
Parkinson's Disease (PD) is the second most common of the age-related neurodegenerative disorders, affecting over 1,900 adults per 100,000 over the age of 80 in the US. The prevalence of sleep dysfunction in PD is estimated at nearly 80-90% which includes sleep fragmentation, insomnia, rapid eye movement (REM or dream sleep) Sleep Behavior Disorder (RBD), Restless legs syndrome (RLS), periodic limb movement, excessive daytime sleepiness, and sleep apnea. Sleep is vital to homeostasis, cognition, and nervous system repair. The dysfunctional sleep accompanying PD adversely affects both motor and non-motor symptoms, resulting in diminished quality of life for both patients and caregivers, including impairments in mood and behavior, and increased morbidity and mortality. Knowledge of sleep phenomenology and pathology in humans has largely been informed by analysis of non-invasive scalp electroencephalogram (EEG), and despite the profound importance of sleep, the underlying neural circuits important for controlling sleep and wakefulness in humans remain poorly understood. This study assesses whether adaptive stimulation of the Subthalamic Nucleus (STN) drives changes in sleep episode maintenance and improves sleep quality. Participants are adults with PD who experience inadequate motor symptom relief, and who have been offered implantation of a deep brain stimulator system targeting STN for the treatment of motor symptoms (standard-of-care). Prior to surgery, participant sleep patterns will be assessed with questionnaires and monitored with a non-invasive watch-like device. Approximately four months after implantation surgery, participants will each receive 2 1-week deep brain stimulation (DBS) treatments and 1 1-week control session with no DBS in random order. Sleep patterns will again be monitored during the treatments and compared to the patterns before surgery.
Conditions Studied
Interventions
- DEVICE Deep Brain Stimulation
Study Locations (2)
Nebraska
- University of Nebraska Medical Center - Omaha
Pennsylvania
- University of Pennsylvania Health System - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-11-18 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05070013
The ClinicalTrials.gov registry entry for NCT05070013 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (97% lower). The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Parkinson's Disease appearing as the primary indexed condition, and to 1 intervention - of which Deep Brain Stimulation is the first listed.
NCT05070013 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Nebraska, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05070013 about?
NCT05070013 is a clinical study titled "Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease (Aim 2)". Parkinson's Disease (PD) is the second most common of the age-related neurodegenerative disorders, affecting over 1,900 adults per 100,000 over the age of 80 in the US. The prevalence of sleep dysfunction in PD is estimated at nearly 80-90% which includes sleep fragmentation, insomnia, rapid eye mov...
What is the current status of trial NCT05070013?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2021-11-18. Estimated completion is 2026-06-30.
What conditions does trial NCT05070013 study?
This clinical trial studies the following conditions: Parkinson's Disease, Sleep Fragmentation.
What interventions are being tested in trial NCT05070013?
The interventions under investigation include: Deep Brain Stimulation (DEVICE).
Who is sponsoring clinical trial NCT05070013?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05070013 being conducted?
This trial has 2 study locations across Nebraska, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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