Collecting data and samples for research on hearing and communication disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather clinical data and biological specimens from individuals with hearing, balance, and communication disorders. Participants, aged 2 years and older, will be screened and their medical records reviewed to evaluate their eligibility for future research studies. The collected data will serve as a repository for future hypothesis generation and research on Ear, Nose, and Throat (ENT) disorders. Importantly, no investigational therapies will be administered during this study.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

* Patients must be age 2 years or older if procedures or treatment are required.
* Patients at risk, suspected of having, have a history of, or currently have a diagnosed hearing, balance, taste, smell, voice, speech, language, and other ENT disorder.
* An NIDCD clinical investigator and PI determines it is in the interest of the patient/individual and NIDCD CRP for the subject to undergo consult, treatment or follow-up at the NIDCD/NIH
* Patient or their Legally Authorized Representative is able to provide informed consent. The consent form will be signed by parents or guardians of patients under the age of 18.
* A subset of enrolled participants with known or suspected PIEZO2-related sensory dysfunction may be asked to participate in the remote taste and oral somatosensory testing procedures. Participation in this component is optional and not required for enrollment or continued participation in the parent protocol.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

* Candidates who do not meet the inclusion criteria.
* Candidates who in the opinion of the PI and clinical team have medical or unstable conditions for which NIDCD and CC consultative services are unable to provide or support optimal care

Participants without known or suspected PIEZO2-related sensory dysfunction will not be asked to complete the sensory testing component. Additional exclusion criteria for taste testing only procedures include:

* Active oral sores, open cuts, or significant oral pain
* Recent oral surgery or dental procedures within the past 7 days
* Known allergy or hypersensitivity to tannins or polyphenols
* Acute upper respiratory infection or conditions that may interfere with taste perception

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Joshua M Levy, M.D. — National Institute on Deafness and Other Communication Disorders (NIDCD)
• Study coordinator: Marcia L Mulquin, R.N.
• Email: mmulquin@mail.nih.gov
• Phone: (227) 215-4574

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.