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Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants

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ClinicalTrials.gov Identifier: NCT03929809
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Camille Dunn, University of Iowa

Brief Summary:
The purpose of this study is to understand the speech perception in noise and in quiet and localization benefits in a laboratory setting in listeners that receive a cochlear implant in an ear with severe to profound hearing loss and have normal, or near-normal hearing in the opposite ear. We will also evaluate the functional benefit of restoring hearing to the impaired ear via questionnaires that subjects will be answering while listening in their natural environment.

Condition or disease Intervention/treatment
Hearing Loss, Unilateral Hearing Loss, Profound Device: Cochlear Implant

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Adult Single-sided deafness
Adult subjects with unilateral single-sided deafness at least 6 months (to ensure stability of hearing loss), but no greater than 10 years will be implanted with a MED-EL Synchrony Cochlear Implant.
Device: Cochlear Implant
adults with unilateral hearing loss who wish to regain bilateral hearing will be implanted with a cochlear implant on their deafened ear.
Other Name: MED-EL Synchrony




Primary Outcome Measures :
  1. Change in AzBio Sentences in Noise [ Time Frame: Pre-operative baseline, 3, 6, 12 months post-activation ]
    The percent correct of words from a list of 20 Target AzBio sentences will be played from 0° azimuth. A list of AzBio sentences will be played in multitalker babble which will be presented in three different conditions: 0° azimuth, S0N90, or S0N270°.

  2. Change in Localization [ Time Frame: Pre-operative baseline, 3, 6, 12 months post-activation ]
    Testing with 16 sounds played randomly from 1 of 8 loudspeakers in a 108 degree arc will be completed with non-implanted ear alone and everyday listening condition at 60 dBA. Subjects will be asked to identify which loudspeaker presented the sound. The RMS error in degrees will be calculated. A lower number indicates better localization ability.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be adults 18 years of age or older who utilize English as their primary language. These adults will have unilateral severe to profound sensorineural hearing loss in one ear for a duration of at least 6 months (to ensure stability of hearing loss), but no greater than 10 years. The contralateral ear will present with with normal, or near-normal, hearing.
Criteria

Inclusion Criteria:

  1. Participants will be adults who utilize English as their primary language.
  2. Unilateral severe to profound sensorineural hearing loss for a duration of at least 6 months (to ensure stability of hearing loss), but no greater than 10 years.
  3. Contralateral ear with normal, or near-normal, hearing.
  4. Poorer ear (ear to be implanted): severe to profound sensorineural hearing loss, defined as pure-tone thresholds 70 dB HL or greater for the frequencies 500, 1000, 2000, 3000, and 4000 Hz with monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, less than or equal to 20%
  5. Better ear (contralateral ear): normal or near-normal hearing defined as pure-tone thresholds no poorer than 30 dB HL at 250, 500, 1000, 2000, and 3000 Hz and no poorer than 40 dB HL at 4000 Hz with monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, of greater than or equal to 85%.
  6. Willingness to comply with all study requirements.
  7. Patent cochlea and normal cochlear anatomy.

Exclusion Criteria:

  1. Medical or psychological conditions that contraindicate undergoing surgery.
  2. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
  3. Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
  4. Unwillingness or inability of the candidate to comply with all investigational requirements.
  5. Active middle ear infection.
  6. Tinnitus primary motivation for implantation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929809


Contacts
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Contact: Camille Dunn, PhD 319-353-8776 camille-dunn@uiowa.edu
Contact: Diane Burke, RN 319-356-1765 diane-burke@uiowa.edu

Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52241
Sponsors and Collaborators
University of Iowa
Investigators
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Principal Investigator: Camille Dunn, PhD University of Iowa

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Responsible Party: Camille Dunn, Assistant Research Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03929809     History of Changes
Other Study ID Numbers: 201901735
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

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