Clinical trial NCT05670496: Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
Official title: Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Loss
Deafness
Keywords: Deafness
Hearing
Speech
Vestibular
Audiology
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2023-01-04
Enrollment: 600
Sex: ALL
Minimum age (years): 2
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief 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.

...

Detailed 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 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.

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

Primary outcomes:
measure: Clinical data collection
timeFrame: Ongoing
measure: Evaluation for clinical studies
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Joshua M Levy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: