NCT04806282

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

Suspended Last updated 8 December 2025

What this trial tests

trial in Meniere's Disease in 58 participants. Suspended.

Timeline

17 August 2021

Primary endpoint
31 December 2030

31 December 2030

Quick facts

Lead sponsor	National Institute on Deafness and Other Communication Disorders (NIDCD)
Status	Suspended
Study type	OBSERVATIONAL
Enrollment	58
Start date	17 August 2021
Primary completion	31 December 2030
Estimated completion	31 December 2030
Sites	1 location across United States

Conditions studied

• Meniere's Disease — all drugs for Meniere's Disease →
• Enlarged Vestibular Aqueduct Syndrome — all drugs for Enlarged Vestibular Aqueduct Syndrome →
• Autoimmune Inner Ear Disease — all drugs for Autoimmune Inner Ear Disease →

Sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Who can join

Adults 18 to 80, any sex, with Meniere's Disease or Enlarged Vestibular Aqueduct Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

...

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. MRI-based measurement of inner ear fluids reveals increased endolymph volume variability in patients with endolymphatic hydrops and hearing instability.
   Telischi J, Strepay D, Li B, Chisholm J, et al · · 2025 · cited 3× · PMID 40596438 · DOI 10.1038/s41598-025-06083-w