Status:
COMPLETED
Sensory Integration of Auditory and Visual Cues in Diverse Contexts
Lead Sponsor:
New York University
Collaborating Sponsors:
The New York Eye & Ear Infirmary
Conditions:
Vestibular Disorder
Hearing Loss, Sensorineural
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
More than 1/3 of adults in the United States seek medical attention for vestibular disorders and hearing loss; disorders that can triple one's fall risk and have a profound effect on one's participati...
Detailed Description
Introduction: Aim 1 is to establish the role of generated and natural sounds in postural control given the visual environment and sensory loss. For that the investigators will measure postural sway in...
Eligibility Criteria
Inclusion
- 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) \<.8; Ocular Vestibular evoked myogenic potential (oVemp) amplitude asymmetry greater than 34%; Cervical (cVemp) amplitude asymmetry greater than 40%. Normal hearing, defined as an unaided PTA \< 26dB HL (0.5-4 kHz) bilaterally.
- Group 2: Acquired severe / profound unilateral hearing loss (i.e., single-sided deafness \[SSD\]), no evidence of retrocochlear pathology on MRI and no active complaint of dizziness (DHI score \< 10) or imbalance. SSD will be defined as having an unaided pure-tone average (PTA) of hearing thresholds at 0.5, 1, 2, and 4 kHz in the affected ear \> 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
- 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.
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT04479761
Start Date
September 15 2021
End Date
December 30 2024
Last Update
February 5 2025
Active Locations (2)
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1
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, United States, 10010
2
New York University Physical Therapy Department
New York, New York, United States, 10010