RecruitingNot Applicable

Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.

United States600 participantsStarted 2023-03-08

Plain-language summary

Background: People with hearing, balance, and taste, smell, voice, speech, language, and other Ear, Nose, and Throat (ENT) disorders may seek treatment at the National Institute on Deafness and Other Communication Disorders (NIDCD). Some of these people may benefit from enrolling in the NIDCD intramural research program to receive their care. Enrolling will also allow investigators to collect participants clinical data and specimens for future research. Objective: This natural history study has 2 goals: (1) to collect data and specimens that may be used for research; and (2) to evaluate participants who may be candidates for other research studies. Eligibility: People aged 2 years or older with a hearing, balance, and communication disorder. Those at risk or who are suspected of having such a disorder are also eligible. Design: Participants will be screened. Their medical records will be reviewed. Participants will agree to have their medical data used for research. Specimens such as blood or other tissue samples may also be used for research. All data and specimens will be collected during their routine care visits. All tests done will be the normal care for each participant s condition. No tests will be done solely for research. Some of these tests may require blood or tissue samples. Some may use special tools to test hearing and balance. Some may test heart or lung function. These tests may also include different types of imaging scans. All tests will be explained. Participants may ask questions at any time. Participants may remain in this study for up to 2 years. If they need further care, they may sign a new consent. ...

Who can participate

Age range2 Years – 99 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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 dy…

What they're measuring

Clinical data collection

Timeframe: Ongoing

Evaluation for clinical studies

Timeframe: Ongoing

Trial details

NCT IDNCT05670496

SponsorNational Institute on Deafness and Other Communication Disorders (NIDCD)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2026-08-01

Contact for this trial

Marcia L Mulquin, R.N.

(227) 215-4574 mmulquin@mail.nih.gov