N/A
N=6
Vestibular Rehabilitation and Otolith Dysfunction
Dizziness
Bottom Line
View on ClinicalTrials.gov: NCT02652442 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Change in Static Subjective Visual Vertical (SVV) — 0.69; 0.58; 0.69; 0.89 degrees — p=0.97
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Centrifugation Distance (Behavioral); Centrifugation Duration (Behavioral); Centrifugation Schedule (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Static Subjective Visual Vertical (SVV) |
0.69; 0.58; 0.69; 0.89; 0.89; 0.32 | 0.97 |
Summary
Recent studies suggest that otolith dysfunction is a common finding in individuals with a history of head trauma/blast exposure and/or noise-induced hearing loss. Therefore, otolith dysfunction may be a significant health concern for the Veteran population, and determining optimal intervention strategies for otolith dysfunction is important for VA healthcare. The purpose of this project is to identify optimum stimulus parameters of a novel treatment, off-axis rotation (centrifugation) for otolith dysfunction, in healthy participants.
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Documented balance or mobility problems, or healthy control without imbalance
- Otolith dysfunction or healthy control without vestibular dysfunction
Exclusion Criteria
- Progressive neurological disorders and central vestibular abnormalities
- Benign paroxysmal positional vertigo
- Superior semicircular canal dehiscence
- Middle-ear pathology with conductive hearing loss
- Lower extremity joint replacement
- Cognitive impairment (Mini Mental Status Exam < 24/30)
- Severe depression (geriatric depression scale 10)
- Severe anxiety (geriatric anxiety inventory 11/30)
- Best-corrected visual acuity worse than 20/40 in the better eye
Data sourced from ClinicalTrials.gov (NCT02652442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.