| March 19, 2008 |
| June 26, 2009 |
| March 2008 |
| February 2012 (final data collection date for primary outcome measure) |
| 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 ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00642343 on ClinicalTrials.gov Archive Site |
| 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 ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Balance in Children With Cochlear Implants |
| Balance in Children With Cochlear Implants |
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. |
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. |
| Phase 0 |
| Interventional |
| Treatment, Open Label, Parallel Assignment, Safety Study |
| Severe, Profound Deafness |
- Behavioral: Evaluation of motor proficiency skills.
- Behavioral: Evaluation of motor proficiency
- Behavioral: Evaluation of motor proficiency.
|
- Placebo Comparator: Children with severe to profound deafness that have not received any intervention.
- Active Comparator: Children with an unilateral cochlear implant.
- Active Comparator: Children with bilateral cochlear implants.
- Active Comparator: Children who receive their second implant during the duration of the study.
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| |
| |
| Enrolling by invitation |
| 150 |
| February 2012 |
| February 2012 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 4 Years to 18 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00642343 |
| Wayne Berryhill, M.D., University of Oklahoma Health Sciences Center |
| BALANCE W/COCHLEAR_BERRYHILL |
| University of Oklahoma |
| American Academy of Otolaryngology-Head and Neck Surgery Foundation |
| Principal Investigator: |
Wayne Berryhill, MD |
University of Oklahoma |
|
|
| University of Oklahoma |
| June 2009 |
