Sensory Integration of Auditory and Visual Cues in Diverse Contexts

NCT04479761 | Completed Results

• 1 other identifier: 20-0312
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Vestibular Disorder; Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (1)

• Root Mean Square Velocity Anterior-posterior [AP] in cm/s (RMSV)

  RMSV is defined the difference in position between two data points divided by the average time interval, with the velocities at each point squared then summed. The square root of this sum is then divided by the number of data points. Higher values reflect more postural sway. This will be calculated as an average across repetitions where participants saw a moving subway environment (dynamic visuals) combined with real-recorded sounds (moving sounds). Higher RMSV indicated less postural stability. This metric is calculated from center-of-pressure data collected by a force platform. Participants were standing on foam placed on the force platform.

  Will be measured during all 60 seconds scenes

Secondary Outcomes (1)

• Root Mean Square Velocity in the Medio-lateral Direction in cm/s (RMSV)

  measured during all 60 seconds scenes

Study Arms (1)

Virtual Reality

EXPERIMENTAL

Participants will be wearing a virtual reality headset and observing 2 types of scenes: abstract (a display of stars) or contextual (a subway station).

Behavioral: Visual and Auditory Cues

Interventions

Visual and Auditory Cues BEHAVIORAL

Within each scene there will be 2 levels of visual input (static or dynamic) combined with 3 levels of sounds (static, none or dynamic). Postural responses to each combination will be evaluated in order to assess the role of generated and natural sounds in postural control and whether static sounds can improve balance within dynamic virtual environments.

Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New York University: lead
• The New York Eye & Ear Infirmary: collaborator

Study Sites (2)

New York Eye and Ear Infirmary of Mount Sinai

New York, New York, 10010, United States

Location

New York University Physical Therapy Department

New York, New York, 10010, United States

Location

Related Publications (1)

• Lubetzky AV, Cosetti M, Harel D, Sherrod M, Wang Z, Roginska A, Kelly J. Real sounds influence postural stability in people with vestibular loss but not in healthy controls. PLoS One. 2025 Jan 24;20(1):e0317955. doi: 10.1371/journal.pone.0317955. eCollection 2025.

  PMID: 39854326 DERIVED

MeSH Terms

Conditions

Vestibular Diseases; Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Hearing Loss; Hearing Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Prof. Anat Lubetzky
• Organization: New York University

anat@nyu.edu

2129989195

Study Officials

• Anat V Lubetzky, PhD

  New York University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will have 3 groups: people with unilateral vestibular loss, people with single-sided hearing loss and controls. All groups will go through the same procedure.

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: September 15, 2021
• Primary Completion: April 15, 2024
• Study Completion: December 30, 2024
• Last Updated: February 5, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)