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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05670496
• Other study ID #: 10001126
• Secondary ID: 001126-DC
• Status: Recruiting
• Start date: March 8, 2023
• Est. completion date: December 1, 2032

Study information

• Verified date: June 12, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Marcia L Mulquin, R.N.
• Phone: (240) 858-3752
• Email: mmulquin[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 1, 2032
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Language Disorders

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical data collection	To collect clinical data or specimens generated in the diagnosis and treatment of hearing, balance and communication disorders	Ongoing
Primary	Evaluation for clinical studies	To evaluate patients to determine candidacy for intramural clinical studies	Ongoing

External Links

•   NIH Clinical Center Detailed Web Page