Balance in Children With Cochlear Implants - Full Text View

Sponsors and Collaborators:	University of Oklahoma American Academy of Otolaryngology-Head and Neck Surgery Foundation
Information provided by:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00642343

Purpose

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.

Condition	Intervention	Phase
Severe, Profound Deafness	Behavioral: Evaluation of motor proficiency skills. Behavioral: Evaluation of motor proficiency Behavioral: Evaluation of motor proficiency.	Phase 0

Genetics Home Reference related topics: nonsyndromic deafness

MedlinePlus related topics: Hearing Disorders and Deafness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Parallel Assignment, Safety Study
Official Title:	Balance in Children With Cochlear Implants

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	150
Study Start Date:	March 2008
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Children with severe to profound deafness that have not received any intervention.	Behavioral: Evaluation of motor proficiency. The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
2: Active Comparator Children with an unilateral cochlear implant.	Behavioral: Evaluation of motor proficiency skills. The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
3: Active Comparator Children with bilateral cochlear implants.	Behavioral: Evaluation of motor proficiency The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
4: Active Comparator Children who receive their second implant during the duration of the study.	Behavioral: Evaluation of motor proficiency The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.

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.

Eligibility

Ages Eligible for Study:	4 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642343

Locations

United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104

Sponsors and Collaborators

University of Oklahoma

American Academy of Otolaryngology-Head and Neck Surgery Foundation

Investigators

Principal Investigator:

Wayne Berryhill, MD

University of Oklahoma

More Information

No publications provided

Responsible Party:	University of Oklahoma Health Sciences Center ( Wayne Berryhill, M.D. )
Study ID Numbers:	BALANCE W/COCHLEAR_BERRYHILL
Study First Received:	March 19, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00642343 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Oklahoma:

Balance
Severe, Profound deafness
Children

unilateral/bilateral cochlear implants
unilateral cochlear implant
bilateral cochlear implants

Study placed in the following topic categories:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness

Otorhinolaryngologic Diseases
Neurologic Manifestations
Hearing Loss
Ear Diseases

Additional relevant MeSH terms:

Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness
Otorhinolaryngologic Diseases

Nervous System Diseases
Neurologic Manifestations
Hearing Loss
Ear Diseases

ClinicalTrials.gov processed this record on May 07, 2009