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N/A N=107 Diagnostic

Sensory Integration of Auditory and Visual Cues in Diverse Contexts

Vestibular Disorder · Hearing Loss, Sensorineural

Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Root Mean Square Velocity Anterior-posterior [AP] in cm/s (RMSV) — 3.59; 3.30; 3.07 cm/s — p=0.005

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

OutcomeResultp-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

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 participation in activities of daily living. Hearing loss has been shown to reduce balance performance and could be one modifiable risk factor for falls. Patients with vestibular hypofunction tend to avoid busy, hectic, visually complex, and loud environments because these environments provoke dizziness and imbalance. While the visual impact on balance is well known, less is known about the importance of sounds. In search for a possible mechanism to explain a relationship between hearing and balance control, some studies suggested that sounds may serve as an auditory anchor, providing spatial cues for balance, similar to vision. However, the majority of these studies tested healthy adults' response to sounds with blocked visuals. It is also possible that a relationship between hearing loss and balance problems is navigated via an undetected vestibular deficit. By understanding the role of auditory input in balance control, falls may be prevented in people with vestibular disorders and hearing loss. Therefore, there is a critical need for a systematic investigation of balance performance in response to simultaneous visual and auditory perturbations, similar to real-life situations. To answer this need, the investigators used recent advances in virtual reality technology and developed a Head Mounted Display (HMD) protocol of immersive environments, combining specific manipulations of visuals and sounds, including generated sounds (i.e., white noise) and real-world recorded sounds (e.g., a train approaching a station). This research will answer the following questions: (1) Are sounds used for balance and if yes, via what mechanism? (2) Do individuals with single-sided hearing loss have a balance problem even without any vestibular issues? (3) Are those with vestibular loss destabilized by sounds? To address these questions, the following specific aims will be investigated in individuals with unilateral peripheral vestibular hypofunction (n=45), individuals with single-sided deafness (n=45), and age-matched controls (n=45): Aim 1: Establish the role of generated and natural sounds in postural control in different visual environments; Aim 2: Determine the extent to which a static white noise can improve balance within a dynamic visual environment.

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.

View full record on ClinicalTrials.gov →

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.

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