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Vestibular DisorderNCT04479761

Sensory Integration of Auditory and Visual Cues in Diverse Contexts

A study testing Visual and Auditory Cues in people with Vestibular Disorder and Hearing Loss, Sensorineural, run by New York University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Visual and Auditory Cues
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
2 sitesUnited States
Study dates
15 Sep 2021to 30 Dec 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • New York Eye and Ear Infirmary of Mount Sinai

    New York, New York, 10010

  • New York University Physical Therapy Department

    New York, New York, 10010

Other trials in United States

About this study

Official title: Sensory Integration of Auditory and Visual Cues in Diverse Contexts Given Age, Vestibular Hypofunction and Hearing Loss

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.

Read the 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 individuals with unilateral peripheral vestibular hypofunction (n=45), individuals with SSD (n=45) and age-matched controls (n=45). They will be tested in an immersive virtual reality environment displaying an abstract 3-wall display of stars or a subway station. Within each environment, we will compare changes in postural sway in response to visual (static, dynamic) and auditory perturbations (no sound, dynamic sound, i.e., rhythmic white noise in the stars environment or natural sounds, such as moving trains, in the subway environment). Aim 2 is to determine the extent to which a static white noise can improve balance (reduce postural sway) within a dynamic visual environment in individuals with and without sensory loss. To accomplish this aim, the 3 groups of participants will be tested within the same visual environment but here we will compare their sway within a sound-free dynamic visual environment to that with static white noise.

System: Visuals were designed in C# language using standard Unity Engine version 2018.1.8f1(64-bit) (©Unity Tech., San Francisco, CA, USA). The scenes will be delivered via an HTC Vive headset (Taoyuan City, Tai-wan) controlled by a Dell Alienware laptop 15 R3 (Round Rock, TX, USA). The Vive has built-in positional track-ing operating at 60Hz and a refresh rate at 90 Hz. Sounds will be delivered via Bose (Bose Corporation, Fram-ingham, MA, USA) QuietComfort 35 wireless headphones II with active noise cancellation and 360º spatial audio. The process of creating auditory cues included over 20 hours of sound field recording based on the targeted scenes and their intensity levels in New York City. Auditory cues were captured with the Sennheiser Ambeo microphone in first order Ambisonics format. The background sounds merged with a sound design process which involved simulating the detailed environmental sounds that exist within the natural environment to develop a real-world sonic representation. The audio files were processed in Wwise and integrated into Unity. Postural sway will be recorded at 100 Hz by Qualisys software for a Kistler 5233A force-platform (Winterthur, Switzer-land).

Data Collection: Potentially eligible participants will complete a demographics form and go through the following diagnostic screening at the Ear Institute: Caloric Test, Video Head Impulse Test (vHIT), Ocular / Cervical Vestibular Evoked Myogenic Potential, and Audiogram. Visual and somatosensory screening will be done at the Ear Institute as well. This first session is expected to take 2.5 hours to complete. Participants will receive questionnaires to complete at home or on the next session. The Dizziness Handicap Inventory (DHI) was designed to identify difficulties that a patient may be experiencing because of dizziness. The Activities-Specific Balance Confidence (ABC) is a measure of confidence in performing various ambulatory activities without falling or feeling 'unsteady'. The State-Trait Anxiety Inventory (STAI) assesses the severity of anxiety symptoms and a generalized tendency to be anxious. The Speech, Spatial and Quality of Hearing 12-item Scale (SSQ12) is a valid, short version of the original SSQ which provides insights on day-to-day hearing loss impact. The virtual reality protocol (testing by the PI at the NYU Human Performance Laboratory) includes 12 conditions: 2 environments (an abstract display of stars, a subway station) X 2 visuals (moving, static) X 3 sounds (dynamic, none, static white noise) each repeated 3 times for a total of 36 trials. It will be randomized and completed over 1-2 sessions, as needed of up to 90 minutes each. Sounds will be played at the highest level that is comfortable to the participant. Scenes are 60 seconds long. Throughout all sessions, the patients will complete the Simulator Sickness Questionnaire, used to monitor participants' symptoms.

Data Analysis: For each of the 3 measures of interest and for each environment, we will fit a linear mixed effects model. Each model will include main effects of group, visual condition, and auditory condition, as well as all 2 and 3-way interactions. The models will also control for caloric and Video Head Impulse Test (vHIT) test results as well as Age Related Hearing Loss and age. For aim 1, we will assess the significance of contrasts between no sounds / dynamic sounds for the different visual conditions and groups. For aim 2, the same will be done for contrasts between no sounds / static sounds. These models estimate the difference in visual weighting and reweighting between the groups, maximizing the information we can obtain from the data by accounting for the inherent multi-level study design (person, conditions, repetitions). Since each person completes various trials for each condition, the linear mixed effects model accounts for these sources of variability. P-values for the fixed effects will be calculated using the Satterthwaite approximation for the degrees of freedom for the T-distribution80. In addition, we will descriptively explore the relationship between DP, area, self-reported outcomes (DHI, ABC, STAI, SSQ12), and age.

Being tested
Visual and Auditory Cues
Medical subject headings
Vestibular Diseases, Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visual and Auditory CuesBehavioural

    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.

Study groups in NCT04479761
Study groupRoleWhat they receive
Virtual RealityExperimentalParticipants will be wearing a virtual reality headset and observing 2 types of scenes: abstract (a display of stars) or contextual (a subway station).
Receives: Behavioral: Visual and Auditory Cues

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Will be measured during all 60 seconds scenes

Secondary outcomes (1)
  1. Root Mean Square Velocity in the Medio-lateral Direction 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.

    Measured: measured during all 60 seconds scenes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2020
  2. Study start15 Sep 2021
  3. Primary completion15 Apr 2024
  4. Study completion30 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04479761
Sponsor's protocol ID
20-0312
Status last verified
Jan 2025
First submitted
16 Jul 2020
Last updated
5 Feb 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39854326
  • Lubetzky AV, Kelly JL, Scigliano K, Morris B, Cheng K, Harel D, Cosetti M. The Relationship between Chronic Unilateral Hearing Loss, Balance Function, and Falls Is Not Informed by Vestibular Status. Otol Neurotol. 2025 Feb 1;46(2):221-228. doi: 10.1097/MAO.0000000000004400. Epub 2024 Dec 11.

    PubMed 39663801

Questions about this trial

What is this clinical trial studying?

A study testing Visual and Auditory Cues in people with Vestibular Disorder and Hearing Loss, Sensorineural, run by New York University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Root Mean Square Velocity Anterior-posterior [AP] in cm/s (RMSV) (time frame: Will be measured during all 60 seconds scenes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04479761, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.

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