Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Washington University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02004535
First received: November 26, 2013
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

The objective of this study is to investigate benefits of binaural hearing for non-traditional cochlear implant candidates (with Asymmetric Hearing Loss). Asymmetric candidates are patients with severe to profound hearing loss in one ear and better hearing in the other ear. (One ear is deaf and the other ear has better hearing and in most cases uses a hearing aid.) The investigators hypothesize that cochlear implantation of the poorer ear provides a functional increase in word and sentence understanding in quiet or noise, perceived benefit, localization ability, and other measures of auditory performance relative to use of the better hearing ear alone.


Condition Intervention
Hearing Loss
Procedure: Cochlear Implantation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Sound localization using a 140 degree, horizontal plane loudspeaker arc [ Time Frame: Change from Pre-implant baseline localization at 12 months post-implant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Speech recognition [ Time Frame: Pre-implant and 1, 3, 6, 9, 12, and 24 months post-implant ] [ Designated as safety issue: No ]
    Speech recognition will be assessed with word and sentence material for the each ear individually as well as bilaterally (both ears together). Testing will be completed in quiet and in the presence of background noise.

  • Perceived benefit questionnaire [ Time Frame: Pre-implant and 1, 3, 6, 12, and 24 months post-implant ] [ Designated as safety issue: No ]
    Speech, Spatial and Qualities of Hearing scale (SSQ; Gatehouse and Noble,2004) will be completed by participants. The SSQ is a 49-item questionnaire that uses a 10-point rating scale (where a 0 rating reflects least ability and 10 reflects greatest ability) to evaluate the effects of hearing loss in terms of disability and function across three domains: Speech Hearing, Spatial Hearing, and Qualities of Hearing.


Other Outcome Measures:
  • Cognitive ability (processing speed, visuospatial working memory, and perceptual effort) [ Time Frame: Pre-implant and 12 months post-implant ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2006
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cochlear implantation
Cochlear implantation of the ear with severe to profound hearing loss
Procedure: Cochlear Implantation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older at time of surgery
  • The poorer ear (implant ear) will have a severe-to-profound hearing loss and meet current cochlear implant candidacy criteria.
  • The better ear (contralateral ear) will have hearing levels less than current cochlear implant candidacy criteria and stable/non-fluctuating hearing levels for at least the previous year
  • Normal/patent cochlear anatomy
  • Fluent in English
  • Desire to have more functional binaural hearing and willingness to comply with all of the study requirements

Exclusion Criteria:

  • Medical or psychological conditions that contraindicate undergoing surgery
  • Additional handicaps that would prevent or restrict participation in the audiological evaluations
  • Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
  • Hearing loss of neural or central origin, including auditory neuropathy
  • Chronic and severe tinnitus in the ear to be implanted
  • Unwillingness or inability to comply with all investigational requirements
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02004535

Contacts
Contact: Laura K Holden, AuD 314-362-7245 HoldenL@ent.wustl.edu
Contact: Noel Y Dwyer, AuD 314-747-0882 DwyerN@ent.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Noel Y Dwyer, AuD    314-747-0882    DwyerN@ent.wustl.edu   
Principal Investigator: Jill B Firszt, PhD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Jill B Firszt, PhD Washington University School of Medicine in St. Louis
  More Information

Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02004535     History of Changes
Other Study ID Numbers: R01DC009010.1, R01DC009010
Study First Received: November 26, 2013
Last Updated: December 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Hearing loss
Asymmetric hearing loss
Cochlear implantation

Additional relevant MeSH terms:
Deafness
Hearing Loss
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014