- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00642343
Balance in Children With Cochlear Implants
June 14, 2010 updated by: University of Oklahoma
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
66
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 1
Children with severe to profound deafness that have not received any intervention.
|
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
Other Names:
|
Active Comparator: 2
Children with an unilateral cochlear implant.
|
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
Other Names:
|
Active Comparator: 3
Children with bilateral cochlear implants.
|
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
Other Names:
|
Active Comparator: 4
Children who receive their second implant during the duration of the study.
|
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
no earlier than 2 weeks following activation of implants
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the differences in balance function between children with bilateral cochlear implants compared to children with unilateral cochlear using implants the BOT2.
Time Frame: no earlier than 2 weeks after implant activation
|
no earlier than 2 weeks after implant activation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wayne Berryhill, MD, University of Oklahoma
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
March 19, 2008
First Submitted That Met QC Criteria
March 24, 2008
First Posted (Estimate)
March 25, 2008
Study Record Updates
Last Update Posted (Estimate)
June 15, 2010
Last Update Submitted That Met QC Criteria
June 14, 2010
Last Verified
June 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BALANCE W/COCHLEAR_BERRYHILL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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