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Sensory Integration Therapy for Balance and Hearing Disorders

N/A
Waitlist Available
Led By Anat V Lubetzky, PhD
Research Sponsored by New York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 1: Unilateral peripheral vestibular hypofunction and normal hearing, e.g., vestibular neuritis, with a complaint of head motion provoked instability or dizziness affecting their functional mobility and quality of life
Timeline
Screening 3 weeks
Treatment Varies
Follow Up will be measured during all 60 seconds scenes
Awards & highlights

Study Summary

This trial will investigate whether sounds can help with balance in people with vestibular disorders and hearing loss.

Who is the study for?
This trial is for adults with certain types of hearing and balance disorders, specifically those with unilateral vestibular hypofunction or single-sided deafness without dizziness. It also includes healthy controls matched by age and sex. Participants must have normal or mild age-related hearing loss and no major neurological conditions, visual impairments that can't be corrected, pregnancy, or acute musculoskeletal pain.Check my eligibility
What is being tested?
The study investigates how sounds and visuals affect balance using virtual reality technology. Participants will experience immersive environments where both generated noises (like white noise) and real-world sounds are manipulated to see if they help improve postural control in people with hearing loss or vestibular disorders.See study design
What are the potential side effects?
Since the intervention involves non-invasive auditory and visual cues through a Head Mounted Display, side effects are minimal but may include temporary discomfort like dizziness from the VR environment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have certain inner ear balance test results showing weakness or asymmetry, and my hearing is normal.
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I have dizziness due to a one-sided inner ear problem but my hearing is normal.
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I feel unstable or dizzy when moving my head and tests show I have a balance problem in one ear.
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I am over 65 and have mild hearing loss without aids.
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I have a balance disorder in one ear but my hearing is normal.
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I am over 65 and have mild hearing loss without aids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~will be measured during all 60 seconds scenes
This trial's timeline: 3 weeks for screening, Varies for treatment, and will be measured during all 60 seconds scenes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sway Area (mm2)
Sway Directional Path (DP) anterior-posterior [AP] and medio-lateral [ML] in mm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Virtual RealityExperimental Treatment1 Intervention
Participants will be wearing a virtual reality headset and observing 2 types of scenes: abstract (a display of stars) or contextual (a subway station).

Find a Location

Who is running the clinical trial?

New York UniversityLead Sponsor
226 Previous Clinical Trials
314,148 Total Patients Enrolled
The New York Eye & Ear InfirmaryOTHER
24 Previous Clinical Trials
3,218 Total Patients Enrolled
Anat V Lubetzky, PhDPrincipal InvestigatorNew York University
1 Previous Clinical Trials
46 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are fresh participants still being sought for this research project?

"According to the records stored on clinicaltrials.gov, this particular research project is currently recruiting participants. It was originally posted in September 2021 and has been given a recent update in October 2022."

Answered by AI

How many volunteers have enrolled in this research initiative?

"Affirmative, the clinicaltrial.gov database indicates that this research is actively seeking participants and has been updated as recently as October 3rd 2022. Its initial posting was on September 15th 2021 with a total of 135 patients needed from two distinct medical sites."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
New York Eye and Ear Infirmary of Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Sensory Integration of Auditory and Visual Cues in Diverse Contexts
2021. "Sensory Integration of Auditory and Visual Cues in Diverse Contexts". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04479761.
All > Sensorineural Hearing Loss > Hearing Loss
~30 spots leftby Apr 2025
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