MRI-based measurement of inner ear fluids reveals increased endolymph volume variability in patients with endolymphatic hydrops and hearing instability.
Julia Telischi, Dillon Strepay, Bing Li...
https://pubmed.ncbi.nlm.nih.gov/40596438Actively Recruiting
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID04806282
Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
Led by National Institute on Deafness and Other Communication Disorders (NIDCD) · Updated on 2026-05-19
210
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating disorders of hearing instability, which cause sudden changes and fluctuations in hearing and speech understanding, but are not well understood or effectively treated. This study aims to create a group of people with hearing instability and analyze their hearing and balance tests along with radiologic and immunologic markers over time. Healthy volunteers will also be included to establish normal ranges for specific MRI measures. Participants will undergo detailed hearing assessments using headphones or earplugs to listen to various tones, balance tests involving goggles, air stimulation of the ears, and spinning chair tests. They will have MRI scans of the inner ear and brain using contrast agents. Blood samples will be collected to study immune markers. Both affected individuals and healthy volunteers aged 18 to 80 can participate, and the study will last up to 15 months. During the study, participants will complete medical histories, physical exams, and hearing tests at scheduled intervals up to 450 days. Researchers will measure hearing fluctuations, immune profiles, and imaging biomarkers to identify features associated with hearing instability. These evaluations include word recognition scores, otoacoustic emissions, vestibular tests, and MRI analysis. The study also monitors participants' safety and compliance throughout the participation period.
CONDITIONS
Brief Title
Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
Who Can Participate
Age: 18Years - 80Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent provided
- Willingness to comply with study procedures and be available for the study duration
- All genders aged 18 to 80 years
- Diagnosed with hearing instability showing sensorineural hearing loss greater than 30 dB HL at one or more frequencies
- Documented clinically significant change in hearing between at least two tests or sudden hearing change
- No air-bone gaps exceeding 10 dB for 500-4000 Hz in at least one ear
- For females of reproductive potential: negative pregnancy test at study start
You will not qualify if you...
- Presence of non-MRI compatible devices such as cardiac pacemaker
- Pregnancy or lactation
- Known allergy to gadolinium contrast
- Febrile illness within 2 weeks affecting immune profiling
- Active outer or middle ear disease or anomaly
- History of chronic or recurrent otitis media
- Current pressure equalization (PE) tubes
- Bilateral profound sensorineural hearing loss (PTA > 90 dB HL)
- History or diagnosis of central nervous system disorders including intracranial tumors, cerebrovascular disease, degenerative CNS disorders, CNS trauma, encephalitis, or meningitis
- Unable to discontinue medications interfering with vestibular tests for 48 hours before testing
- Current diagnosis of schizophrenia, bipolar disorder, or psychosis
- Unstable intercurrent illness preventing or confounding data collection
- Cognitive impairment lacking consent capacity
- Suspected COVID-19 infection until resolved
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Approximately 15 months
Participants with hearing instability are observed and undergo repeated assessments to identify phenomic features associated with hearing fluctuation and related biomarkers over time.
5 visits approximately every 90 days (+/- 14 days)
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Loading map...
Research Team
A
Anna E Clements Centeno
M
Michael Hoa, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here