Collecting data and samples for research on hearing and communication disorders
Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
This study is collecting health information and samples from people aged 2 and up with hearing and communication disorders to help with future research on these issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 2 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05670496 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 2 years or older with diagnosed or suspected hearing, balance, or communication disorders.
Not a fit: Patients who do not meet the inclusion criteria or have conditions deemed unsuitable by the clinical team may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding and treatment options for patients with hearing and communication disorders.
How similar studies have performed: Other studies focusing on similar data collection methods have shown promise in advancing research in ENT disorders, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.