Hearing Loss, UnilateralNCT03929809
Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants
An observational study of Hearing Loss, Unilateral and Hearing Loss, Profound, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Unilateral, Hearing Loss, Profound
- What is being tested?
- Cochlear Implant
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2019to 18 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participants will be adults who utilize English as their primary language.
- 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.
- Contralateral ear with normal, or near-normal, hearing.
- 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%
- 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%.
- Willingness to comply with all study requirements.
- Patent cochlea and normal cochlear anatomy.
Who cannot join
- Medical or psychological conditions that contraindicate undergoing surgery.
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- 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.
- Unwillingness or inability of the candidate to comply with all investigational requirements.
- Active middle ear infection.
- Tinnitus primary motivation for implantation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hearing Loss, Unilateral, Hearing Loss, Profound
- Being tested
- Cochlear Implant
- Medical subject headings
- Hearing Loss, Unilateral, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear ImplantDevice
Also called MED-EL Synchrony
adults with unilateral hearing loss who wish to regain bilateral hearing will be implanted with a cochlear implant on their deafened ear.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cochlear Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AzBio Sentences in Noise
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°.
Measured: Pre-operative baseline, 3, 6, 12 months post-activation
Change in Localization
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.
Measured: Pre-operative baseline, 3, 6, 12 months post-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start20 Jun 2019
- Primary completion18 Aug 2021
- Study completion18 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, UnilateralStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camille Dunn, University of Iowa
- Investigators
- Camille Dunn, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929809
- Sponsor's protocol ID
- 201901735
- Status last verified
- Sep 2020
- First submitted
- 22 Apr 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants
- ClinicalTrials.gov ID
- NCT03929809
- Acronym / sponsor ID
- 201901735
- Conditions
- Hearing Loss, Unilateral, Hearing Loss, Profound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 18 Aug 2021 (actual)
- Study completion
- 18 Aug 2021 (actual)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Single-sided deafness | – | Device: Cochlear ImplantAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Participants will be adults who utilize English as their primary language.
- 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.
- Contralateral ear with normal, or near-normal, hearing.
- 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%
- 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%.
Key exclusion criteria (6 listed)
- Medical or psychological conditions that contraindicate undergoing surgery.
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- 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.
- Unwillingness or inability of the candidate to comply with all investigational requirements.
- Active middle ear infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear ImplantAlso: MED-EL Synchronyadults with unilateral hearing loss who wish to regain bilateral hearing will be implanted with a cochlear implant on their deafened ear. | Device | Adult Single-sided deafness |
Primary outcome
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°.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss, Unilateral
RecruitingObservational study
Audiological Rehabilitation of Children With Unilateral Hearing Loss
Unilateral Hearing Loss
RecruitingPhase 1/2
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Vestibular Schwannoma
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
Unilateral Hearing Loss, Asymmetric Hearing Loss
Active, not recruiting
Single-Sided Deafness and Asymmetric Hearing Loss
Hearing Loss, Unilateral, Hearing Loss, Sensorineural
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camille Dunn, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Unilateral and Hearing Loss, Profound, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in AzBio Sentences in Noise (time frame: Pre-operative baseline, 3, 6, 12 months post-activation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.