NCT04806282 · National Institute on Deafness and Other Communication Disorders (NIDCD)
Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets
What this study is about
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.
View original scientific 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. ...
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- will require documentation of clinically significant change in hearing (either worsening or improvement) between at least 2 hearing tests or documentation of a sudden change in hearing. Clinically significant change in hearing will be defined by a change of10 dB at any three frequencies, 15 dB at any two frequencies, or at least 20 dB at one frequency. A sudden change in hearing will be defined as at least a 30 dB difference at 3 consecutive frequencies in the affected ear as compared to the contralateral ear.
- No air-bone gaps in excess of 10 dB for 500-4000 Hz indicative of conductive HL in at least 1 ear.
- For females of reproductive potential: Negative pregnancy test at start of study Unaffected Adults In order to be eligible to participate in this study as a healthy volunteer, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- All genders, aged 18-80 years
- No air-bone gaps in excess of 10 dB for 500-4000Hz indicative of conductive HL in at least one ear.
- Normal middle ear function as indicated by normal 226 Hz tympanograms bilaterally, defined as middle ear pressure between plus minus 100 decaPascals, and peak compensated static compliance between 0.3-1.8 milliliters
- For females of reproductive potential: Negative pregnancy test at start of study
Exclusion criteria
- 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
- Encephalitis
- 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
- Bethesda, Maryland
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations