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Clinical Trials/NCT00642343
NCT00642343
Completed
Early Phase 1

Balance in Children With Cochlear Implants

University of Oklahoma1 site in 1 country66 target enrollmentMarch 2008

Overview

Phase
Early Phase 1
Intervention
Not specified
Conditions
Severe, Profound Deafness
Sponsor
University of Oklahoma
Enrollment
66
Locations
1
Primary Endpoint
The specific aim will be to compare the balance of children with cochlear implants to profoundly deaf children using the BOT2.
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

The purpose is to test the balance of children with unilateral,bilateral cochlear implants and patients having unilateral implants before,bilateral implants after surgery,using the Bruininks-Oseretsky Test 2nd ed. to find out if the cochlear implants have an effect.

Detailed Description

Hearing impairment has a significant impact on individual quality of life and stresses community resources. In the last two decades cochlear implantation has developed into the new standard of care for severe to profound haring loss. Recent studies have shown bilateral implantation improves sound localization and understanding of speech in noise. For children, this is seen as a significant benefit. As we begin to offer bilateral cochlear implants to a growing number of children it would be in our patient's best interest to evaluate whether or not this may cause balance impairment. We will evaluate the balance scores of children with bilateral cochlear implants, and compare their results to unilaterally implanted children and a hearing impaired population, with the Bruininks-Oseretsky Test 2nd ed (BOT2). In addition we will take a small group of unilaterally implanted patients and test them before and after a contralateral cochlear implant as a prospective study group.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
June 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Children with cochlear implant(s) activated for at least two weeks before participation.
  • Children with severe to profound deafness that have not received intervention.

Exclusion Criteria

  • Children with mental retardation, associated physical handicaps, or chronic sedative use prohibiting completion of the balance tests.

Outcomes

Primary Outcomes

The specific aim will be to compare the balance of children with cochlear implants to profoundly deaf children using the BOT2.

Time Frame: no earlier than 2 weeks following activation of implants

Secondary Outcomes

  • To evaluate the differences in balance function between children with bilateral cochlear implants compared to children with unilateral cochlear using implants the BOT2.(no earlier than 2 weeks after implant activation)

Study Sites (1)

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