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NCT05676944 · ClinicalTrials.gov registry record · NA
Vestibular Implantation in Older Adults
A NA study of Vestibular Diseases and Sensation Disorders, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT05676944: Recruiting NA study of Vestibular Diseases and Sensation Disorders, sponsored by Johns Hopkins University.
NCT05676944 is a NA study of Vestibular Diseases and Sensation Disorders that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 15 participants, below the 13,368-participant average among 6 other Vestibular Diseases trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05676944, a NA study of Vestibular Diseases and Sensation Disorders, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior research has demonstrated that electrical stimulation of the vestibular nerve via a chronically implanted multichannel vestibular implant can partially restore vestibular reflexes that normally maintain steady posture and vision; improve performance on objective measures of postural stability and gait; and improve patient-reported disability and health-related quality of life. This single-arm open-label study extends that research to evaluate outcomes for up to fifteen older adults (age 65-90 years at time of enrollment) with ototoxic or non-ototoxic bilateral vestibular hypofunction.
Primary Outcome
DGI comprises 8 gait tasks scored by an examiner: walking on a level surface, changing gait speed, walking during horizontal head turns, walking during vertical head turns, pivoting, stepping over an obstacle, stepping around obstacles, and waling up and down stairs. Each task is scored (0-3 points, 3 is best). Raw DGI score is the sum of the eight subtest scores and ranges from 0 to 24, with higher scores meaning better outcome and minimally important difference 3.2 points.
Conditions Studied
Interventions
- DEVICE Labyrinth Devices MVI™ Multichannel Vestibular Implant System
Study Locations (1)
Maryland
- Johns Hopkins School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2023-04-11 |
| Est. Completion | 2028-01-31 |
| Phase | NA |
What NCT05676944 shows while recruiting
NCT05676944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 13,368-participant average among 6 other Vestibular Diseases trials with a reported enrollment target (100% lower).
The record links to 10 conditions, with Vestibular Diseases appearing as the primary indexed condition, and to 1 intervention - of which Labyrinth Devices MVI™ Multichannel Vestibular Implant System is the first listed.
NCT05676944 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05676944 about?
NCT05676944 is a clinical study titled "Vestibular Implantation in Older Adults". Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no widely available, adequately effective treatment for individuals suffering chronic imbalance, postural instability and unsteady vision due to bilateral vestibular hypofunction. Prior ...
What is the current status of trial NCT05676944?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2023-04-11. Estimated completion is 2028-01-31.
What conditions does trial NCT05676944 study?
This clinical trial studies the following conditions: Vestibular Diseases, Sensation Disorders, Gentamicin Ototoxicity, Labyrinth Diseases, Bilateral Vestibular Hypofunction.
What interventions are being tested in trial NCT05676944?
The interventions under investigation include: Labyrinth Devices MVI™ Multichannel Vestibular Implant System (DEVICE).
Who is sponsoring clinical trial NCT05676944?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05676944 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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