Clinical trial: Sensory Integration of Auditory and Visual Cues in Diverse Contexts (NCT04479761)

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) <.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 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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the clinic complaining of dizziness.  She also has occasional nausea and ringing in her right ear.  The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal.  The dizziness improves spontaneously, and she feels fine between episodes.  Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl.  She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago.

Patient description (patient's own words): The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now.

Does the patient match the trial criteria? 0