Recruiting

Observational Study

Sponsor:

National Institute on Deafness and Other Communication Disorders (NIDCD)

Code:

NCT06303180

Conditions

Hearing Loss

Head and Neck Neoplasms

Hearing Disorders

Laryngeal Disease

Eligibility Criteria

Sex: All

Age: 3 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Background:

Many disorders of the head and neck can affect a person s hearing; balance; smell; taste; swallowing; voice; or speech. These disorders include cancers and genetic and inflammatory diseases. To find better ways to diagnose and treat these disorders, researchers need to study tissues and other biological samples from people who have them.

Objective:

To collect biological samples for a repository that will be used for research.

Eligibility:

People of any age with a disorder of the head and neck that requires the taking of biological samples. The conditions may be any that affect hearing; balance; smell; taste; swallowing; voice; or speech.

Design:

Part 1: Participants will give permission for their leftover tissue samples to be used for research. These are tissue samples from the head and neck that were collected in the course of routine tests and care or other research studies. Information on each participant s age, diagnosis, and previous treatments will also be collected.

Part 2: Some participants may be asked for more samples. All those aged 3 years or older will have a physical exam. They will provide blood and saliva samples. A cotton swab or brush will be used to collect cells from the inside of the cheek.

Participants 18 years or older may have additional tests. They may provide nasal secretions: A piece of gelfoam or a sponge will be placed in the nose to soak up secretions for 5 to 10 minutes. They may have biopsies: Small samples of tissue will be cut from the skin and the tissue lining the mouth.

Samples may be used for genetic testing.

Conditions

Hearing Loss

Head and Neck Neoplasms

Hearing Disorders

Laryngeal Disease

Study ID

NCT06303180

Start date

Mar 4, 2024

Status verified date

Nov 12, 2025

Completion date

Dec 30, 2033

Anticipated

Primary completion date

Dec 30, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 70+

Healthy Volunteers: Not accepted

  • INCLUSION CRITERIA

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

  • Ability to provide their own consent, or for minors, a parent or guardian is able to consent on their behalf.
  • Ability of subject (or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
  • Have a hearing, balance, smell, taste, voice, speech or language condition for which the subject is under clinical care or research purposes under a separate Review Board (IRB) approved protocol; OR be a healthy volunteer aged at least 3 years, enrolled on an approved research protocol.

EXCLUSION CRITERIA

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

  • Have active symptomatic major organ disorders that would increase the risk of biopsy for research, including but not limited to bleeding disorders, ischemic heart disease, a recent myocardial infarction, active congestive heart failure or severe pulmonary dysfunction
  • Have specific medical condition, such as a bleeding tendency where additional biopsies or phlebotomy procedures may increase the subjects risk in participating. This will be determined at the discretion of the principal investigator.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Patients with head and neck conditions affecting hearing, balance, smell, taste, swallowing, voice and speech.

Primary outcome measure

  • To create a biorepository of diseased and normal tissue specimens for research purposes. [ Time Frame: Ongoing ]

Central Contacts and Locations

Central contacts

Maame S Akumatey

(227) 233-0452maame.akumatey@nih.gov

Joshua M Levy, M.D.

(240) 935-8305joshua.levy@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Marcia Mulquin, RN, MSN

301-496-1601mmulquin@mail.nih.gov

NIH Clinical Center Office of Patient Recruitment (OPR)

(800) 411-1222ccopr@nih.gov

More Information

Sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Last update posted

Nov 14, 2025

Last verified

Nov 12, 2025

Keywords

  • Hearing
  • Balance
  • Speech
  • Taste
  • SMELL
  • Tissue Sample
  • Genomic DNA
  • Saliva

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute on Deafness and Other Communication Disorders (NIDCD) on 2025-11-14.