Sensory Integration of Auditory and Visual Cues in Diverse Contexts
Vestibular Disorder · Hearing Loss, Sensorineural
Bottom Line
View on ClinicalTrials.gov: NCT04479761 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Visual and Auditory Cues (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- New York University
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Root Mean Square Velocity Anterior-posterior [AP] in cm/s (RMSV) |
3.59; 3.30; 3.07 | 0.005 sig |
| SECONDARY Root Mean Square Velocity in the Medio-lateral Direction in cm/s (RMSV) |
1.66; 1.50; 1.43 | 0.008 sig |
Summary
Eligibility Criteria
Inclusion Criteria
Group 1: Unilateral peripheral vestibular hypofunction and normal hearing, e.g., vestibular neuritis.
a complaint of head motion provoked instability or dizziness affecting their functional mobility and quality of life at least 1 positive finding indicating unilateral vestibular hypofunction on the following clinical tests: head thrust, subjective visual vertical and horizontal, post head shaking nystagmus, spontaneous and gaze holding nystagmus a score of at least 16 (mild handicap) on the Dizziness Handicap Inventory (DHI).
meeting at least 1 of the following diagnostic criteria: 25% or above unilateral weakness on caloric testing; Low gain on Video Head Impulse Test (vHIT) 70 dB HL and normal hearing in the contralateral ear. Normal hearing will be defined as an unaided PTA < 26dB HL (0.5-4 kHz). This is considered healthy hearing according to the World Health Organization.
Group 3: Healthy controls who are matched for age and sex with group 1.
For those above 65 years of age, symmetric age-related hearing loss (ARHL) in the mild hearing loss range, specifically an unaided PTA < 40 dB (0.5-4KHz) will be included.
Exclusion Criteria
a medical diagnosis of peripheral neuropathy; lack of protective sensation based on the Semmes-Weinstein 5.07 Monofilament Test; conductive hearing loss or air bone gap; visual impairment above 20/63 (NYS Department of Motor Vehicle cutoff for driving) on the Early Treatment Diabetic Retinopathy Study (ETDRS) Acuity Test that cannot be corrected with lenses; pregnancy; any neurological condition interfering with balance or walking (e.g. multiple sclerosis, Parkinson's disease, stroke); acute musculoskeletal pain at time of testing; currently seeking medical care for another orthopaedic condition; inability to read an informed consent in English, Spanish or Chinese. Control participants will be excluded for any positive finding on the vestibular diagnostic testing or history of vestibular symptoms (dizziness, vertigo) or any hearing loss that does not fit ARHL as per the criteria specified above.
Patients with vestibular hypofunction will be excluded if they are diagnosed with an unstable peripheral lesion, e.g., Meniere's Disease, Perilymphatic Fistula, Superior Canal Dehiscence, or Acoustic Neuroma.
Data sourced from ClinicalTrials.gov (NCT04479761). 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.