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

Recruiting
2 years of age
Both
Phase N/A

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Overview

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.

...

Description

Study Description:

It may be in the interest of the NIDCD Clinical Research Program (CRP) to collect clinical data or specimens generated in the diagnosis and treatment of hearing, balance, taste, smell, voice, speech, language, and other Ear, Nose, and Throat (ENT) disorders and to evaluate patients to determine candidacy for intramural clinical studies. This protocol will provide the administrative vehicle to enable the evaluation and provision of clinical care for patients with hearing, balance and communication disorders by the NIDCD CRP, Clinical Center, and consult services as well as to provide a repository of information on enrolled subjects to allow for hypothesis generation in future research. No investigational therapies will be administered in this study.

Objectives
  • To provide a repository of data and samples collected from clinical data or specimens generated in the diagnosis and treatment of hearing, balance, taste, smell, voice, speech, language, and other ENT disorders to allow for hypothesis generation in future research.
  • To evaluate patients to determine candidacy for intramural clinical studies

Eligibility

  • 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.
        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

Study details

Hearing Loss, Deafness

NCT05670496

National Institute on Deafness and Other Communication Disorders (NIDCD)

23 June 2024

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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