Hearing impairment - Clinical trial details 

Natural History and Genetic Studies of Usher Syndrome

Recruitment status:
Recruiting
Primary Sponsor:
National Eye Institute (NEI)
Recruitment countries:
Israel,  United States
Health condition studied:
Congenital Deafness
URL:
Link to the clinical trial website

About the trial

Interventions:
Key inclusion and exclusion criteria:

  • - INCLUSION CRITERIA:

    Eligible participants must:

    1. have documented neurosensory hearing loss and retinitis pigmentosa and fulfill the
    clinical characteristics for USH1, USH2 and USH3 as defined by the Usher syndrome
    consortium. ; OR

    2. be unaffected family members of a proband with Usher s syndrome, primarily parents
    and siblings. Family members will be considered unaffected by history if they have
    had previous normal ophthalmologic and hearing examinations and if they don't have
    decreased night or peripheral vision.

    EXCLUSION CRITERIA:

    Patients will be ineligible if they:

    1. had an intrauterine infection, perinatal/congenital infections, or intrauterine and
    birth complications. These conditions can result in damage to both the auditory or
    visual system.

    2. have concurrent inherited or acquired conditions that affect the visual and/or
    auditory system and significantly alter the phenotype.

    Both affected and unaffected individuals will be ineligible if they:

    1. Are unwilling or unable to provide a blood sample or unable to undergo the study
    procedures.

    2. Are younger than 2 years old.
  • Age minimum:  2 Years
  • Age maximum:  N/A
  • Gender:  Both
Primary outcomes:
Secondary outcomes:
Target sample size:
400
Study type:
Observational
Study design:
N/A
Contacts:
  • Name:   For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
  • Address: 
  • Phone:  800-411-1222
  • Email:  prpl@mail.cc.nih.gov
  • Affiliation: 
  • Name:   Wadih Zein, M.D.
  • Address: 
  • Phone: 
  • Email: 
  • Affiliation:  National Eye Institute (NEI)
  • Name:   Wadih Zein, M.D.
  • Address: 
  • Phone:  (301) 496-8118
  • Email:  zeinw@mail.nih.gov
  • Affiliation: 

Technical details

Scientific title:
Natural History and Genetic Studies of Usher Syndrome
Sources of monetary support:
Please refer to primary and secondary sponsors
Secondary sponsors:
Main ID:
NCT00106743
Secondary ID:
05-EI-0096
050096
Register:
ClinicalTrials.gov
Date of registration:
29/03/2005
Date of first enrollment:
March 2005
Last refreshed:
7 April 2014

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