Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets

Recruiting now

Conditions studied: Meniere's Disease, Enlarged Vestibular Aqueduct Syndrome, Autoimmune Inner Ear Disease

In brief

Background: Disorders of hearing instability (HI) are poorly characterized and ineffectively treated. HI can cause fluctuations in hearing thresholds and speech understanding. Researchers want to use a specialized form of magnetic resonance imaging (MRI) and blood tests to learn more about HI. Objective: To characterize a cohort of people with HI and to correlate HI with other data, including hearing evaluations, as well as radiologic and immunologic biomarkers of inflammation over time. Eligibility: Adults ages 18-80 who have symptoms consistent with possible HI. Design: Participants will be screened with a medical and hearing history and medical record review. Participants will have physical exams. Their head and neck will be examined. They will have blood drawn. Participants will have hearing tests. They will wear headphones or foam earplugs. They will listen to different tones. They may describe what they hear. Participants will have balance tests. They will wear goggles as they watch moving lights or while cold or warm air is blown into their ears. They will sit in a spinning chair in a quiet, dark booth. From a reclining position, they will raise their head while clicking sounds are played into their ears. Participants will have MRIs of the inner ear and brain. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During the MRIs, participants will lie on a table that slides in and out of the scanner. Soft padding or a coil will be placed around their head. They will get a contrast agent through an intravenous catheter. Participation will last up to 15 months. ...

Key facts

Study ID

NCT04806282

Run by

National Institute on Deafness and Other Communication Disorders (NIDCD)

People needed

210

Starts

2021-08-17

Expected to finish

2030-12-31

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Affected and unaffected individuals who meet any of the following criteria will be excluded from participation in this study:
• Presence of non-MRI compatible devices (cardiac pacemaker, meta<specific devices (e.g., cardiac pacemaker)
• Pregnancy or lactation
• Known allergic reactions to gadolinium
• Febrile illness within 2 weeks that could affect immune profiling*
• Evidence of active outer or middle ear disease or anomaly (e.g. otitis media, stenotic ear canal, otorrhea)
• History of chronic, as defined by fluid in the middle ear for more than 4 months, or recurrent otitis media, as defined by more than 4 episodes of acute otitis media in one year.
• Current PE tubes
• Bilateral profound (Pure tone average (PTA) > 90 dB HL) sensorineural hearing loss
• History or diagnosis of a central nervous system disorder, including but not limited to:
• Intracranial tumors
• Cerebrovascular disease
• Degenerative CNS disorder
• CNS trauma
• Encephalitis
• Meningitis
• Unable to discontinue medications that can interfere with vestibular test results for the 48 hours immediately preceding a vestibular study session. These include any and all anti-dizziness medications (such as Antivert), alcohol, caffeine, prescription pain medications (such as Percocet), prescription headache medications (such as Imitrex), sleeping pills (such as Ambien), anti-seizure medications (such as Topamax), and/or antihistamines (such as Benadryl).
• Current diagnosis from the Diagnostic and Statistical Manual of Mental Disorders (DSM IV) of schizophrenia, bipolar disorder, or psychosis.
• Unstable intercurrent illness that in the judgment of the PI could prevent or confound collection of data.
• Prospective study subjects who are cognitively impaired and lack consent capacity, will not be enrolled.
• Participants suspected of having COVID-19 will be moved to the designated COVID-19 unit and tested for SARS CoV-2 and Respiratory Pathogen Panel per guidance from NIH CC Clinical Practice Safety Guidelines. Possible COVID-19 infections identified by phone screen will not be eligible for study protocol until infection resolved.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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