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.
...
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 500-4000 Hz indicative of conductive HL in at least 1 ear.
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*
This study will enroll up to a total of 150 patients with HI. The enrollment target is between 10-30 patients per clinical subtype for at least 2 clinical subtypes of HI (i.e., without or with EH, without or with significant immune cell, cytokine or FLAIR positivity). 20 cytokines/chemokines in patients with Meniere s disease that revealed statistically higher levels of IL-1Beta compared to healthy controls (Flook et al., 2019), a sample size of 40-50 patients would be required for 80% power to detect an immune subtype associated with IL-1Beta.
Cohort
Prospective
Not listed
Phenomic features
To identify phenotype features associated with hearing fluctuation
Subdivisions of phenomic features
To Identify a variety of phenomic features of patients with HI that allow assignment to clinical subdivisions.
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