Severe, Profound Deafness Clinical Trial
Official title:
Balance in Children With Cochlear Implants
Verified date | June 2010 |
Source | University of Oklahoma |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 4 Years to 18 Years |
Eligibility |
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma | American Academy of Otolaryngology-Head and Neck Surgery Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The specific aim will be to compare the balance of children with cochlear implants to profoundly deaf children using the BOT2. | no earlier than 2 weeks following activation of implants | Yes | |
Secondary | 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 | Yes |