NCT00023049

Brief Summary

This study will try to identify the genetic causes of hereditary hearing loss or balance disorders. People with a hearing or balance disorder that affects more than one family member may be eligible for this study. They and their immediate family members may undergo some or all of the following procedures:

  • Medical and family history, including questions about hearing, balance and other ear-related issues, and review of medical records.
  • Routine physical examination.
  • Blood draw or buccal swab (brushing inside the cheek to collect cells) - Tissue is collected for DNA analysis to look for changes in genes that may be related to hearing loss.
  • Hearing tests - The subject listens for tones emitted through a small earphone.
  • Balance tests to see if balance functions of the inner ear are associated with the hearing loss In one test the subject wears goggles and watches moving lights while cold or warm air is blown into the ears. A second test involves sitting in a spinning chair in a quiet, dark room.
  • Photograph - A photograph may be taken as a record of eye shape and color, distance between the eyes, and hair color.
  • Computed tomography (CT) and magnetic resonance imaging (MRI) scans - These tests show the structure of the inner ear. For CT, the subject lies still for a short time while X-ray images are obtained. For MRI, the patient lies on a stretcher that is moved into a cylindrical machine with a strong magnetic field. The magnetic field and radio waves produce images of the inner ear. The radio waves cause loud thumping noises that can be muffled by the use of earplugs.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2001

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 23, 2002

Completed
Last Updated

April 24, 2026

Status Verified

February 23, 2026

First QC Date

August 21, 2001

Last Update Submit

April 23, 2026

Conditions

Keywords

DeafnessPhenotypesNatural History StudyAuditoryDNA MutationsNatural HistoryHereditary Hearing DisorderHearing ImpairmentSensorineural Hearing LossVestibular DysfunctionSNHL

Outcome Measures

Primary Outcomes (1)

  • To define and characterize the phenotypes and natural histories of families with segregating hereditary disorders of balance or hearing and to identify the possible mutations and genes by genetic analysis

    Characterize the natural history of hereditary disorders affecting hearing and/or balance Identify the genes, including both known and as yet undiscovered genes, that can cause hereditary disorders of hearing or balance Identify and characterize the structure and functions of these genes in the development and function of the peripheral auditory and vestibular systems Determine how mutations in these genes cause hearing loss and vestibular dysfunction Correlate genotypes and phenotypes to identify clinical features that may be used to facilitate the genetic diagnosis of hereditary disorders affecting hearing or balance

    Ongoing

Study Arms (1)

1

patients with known SNHL and/or peripheral vestibular dysfunction

Eligibility Criteria

AgeUp to 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We will be studying up to 750 people with hearing losses or balance problems that are thought to be hereditary and, if possible, their family members, either with or without hearing or balance problems to participate in our study. A total of up to 400 affected and unaffected individuals, including family members and control subjects will be enrolled from the Nigerian population.

You may qualify if:

  • Persons with known SNHL and/or peripheral vestibular dysfunctions caused by genetic etiology
  • Family members of persons with known SNHL and/or peripheral vestibular dysfunction caused by genetic etiology
  • Adults must be able to provide informed consent
  • Minors must have a parent or guardian able to provide informed consent
  • Subjects must be 0-99 years of age
  • For Nigeria subjects with non-syndromic hearing loss, their hearing loss must be early-onset, before 10 years of age, to be eligible.

You may not qualify if:

  • Persons with SNHL and/or peripheral vestibular dysfunction caused by a nongenetic etiology such as trauma, infection, metabolic or immunologic disorders, or exposure to ototoxic agents such as noise or aminoglycoside antibiotics will not be included in this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Institute of Child Health, College of Medicine, University of Ibadan

Ibadan, Nigeria

Location

Related Publications (3)

  • Cohn ES, Kelley PM, Fowler TW, Gorga MP, Lefkowitz DM, Kuehn HJ, Schaefer GB, Gobar LS, Hahn FJ, Harris DJ, Kimberling WJ. Clinical studies of families with hearing loss attributable to mutations in the connexin 26 gene (GJB2/DFNB1). Pediatrics. 1999 Mar;103(3):546-50. doi: 10.1542/peds.103.3.546.

    PMID: 10049954BACKGROUND
  • Griffith AJ, Friedman TB. Making sense out of sound. Nat Genet. 1999 Apr;21(4):347-9. doi: 10.1038/7668. No abstract available.

    PMID: 10192378BACKGROUND
  • Morton NE. Genetic epidemiology of hearing impairment. Ann N Y Acad Sci. 1991;630:16-31. doi: 10.1111/j.1749-6632.1991.tb19572.x. No abstract available.

    PMID: 1952587BACKGROUND

Related Links

MeSH Terms

Conditions

Hearing Loss, SensorineuralHearing DisordersVestibular DiseasesDeafnessHearing Loss

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLabyrinth Diseases

Study Officials

  • Thomas B Friedman, Ph.D.

    National Institute on Deafness and Other Communication Disorders (NIDCD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2001

First Posted

August 22, 2001

Study Start

December 23, 2002

Last Updated

April 24, 2026

Record last verified: 2026-02-23

Locations