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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: Recruiting NA study of Parkinson's Disease and Sleep Fragmentation, sponsored by University of Nebraska.
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 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Sleep fragmentation frequency will be measured using FDA-approved wrist-based Actigraphy (ActiWatch Spectrum Pro). Comparisons will be made between baseline and each of the interventions.
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 |
What NCT05070013 shows while recruiting
NCT05070013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05070013's enrollment target sits among peer trials
20 129th of 158 higher than 24 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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