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| ID | Type | Description | Link |
|---|---|---|---|
| 001126-DC |
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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.
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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. As part of hypothesisgenerating research related to taste and oral sensation, participants may undergo brief sensory testing using food-grade tannic acid solutions. This testing is designed to characterize taste, mouthfeel, and chemesthetic responses and does not involve administration of investigational agents or swallowing of test solutions.
Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients at risk, suspected of having, have a history of, or currently have a diagnosed hearing, balance or communication disorder. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical data collection | To collect clinical data or specimens generated in the diagnosis and treatment of hearing, balance and communication disorders | Ongoing |
| Evaluation for clinical studies | To evaluate patients to determine candidacy for intramural clinical studies | Ongoing |
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In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
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:
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Patients at risk, suspected of having, have a history of, or currently have a diagnosed hearing, balance and communication disorders referred to NIDCD Clinical Investigators by the Intramural Consult Service or community providers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcia L Mulquin, R.N. | Contact | (227) 215-4574 | mmulquin@mail.nih.gov | |
| Joshua M Levy, M.D. | Contact | (240) 935-8305 | joshua.levy@nih.gov |
| Name | Affiliation | Role |
|---|---|---|
| Joshua M Levy, M.D. | National Institute on Deafness and Other Communication Disorders (NIDCD) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Recruiting | Bethesda | Maryland | 20892 | United States |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D003638 | Deafness |
| D013060 | Speech |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
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