Balance in Children With Cochlear Implants

Severe, Profound Deafness Clinical Trial

Official title:

Balance in Children With Cochlear Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00642343
• Other study ID #: BALANCE W/COCHLEAR_BERRYHILL
• Status: Completed
• Phase: Phase 0
• First received: March 19, 2008
• Last updated: June 14, 2010
• Start date: March 2008
• Est. completion date: June 2010

Study information

• 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

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Severe, Profound Deafness

Intervention

Behavioral:
• Evaluation of motor proficiency skills.
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
• Evaluation of motor proficiency
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
• Evaluation of motor proficiency
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
• Evaluation of motor proficiency.
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	American Academy of Otolaryngology-Head and Neck Surgery Foundation

Country where clinical trial is conducted

United States, 

Outcome

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