Hearing LossNCT05052944
Single-sided Deafness and Cochlear Implantation
An observational study of Hearing Loss and Hearing Loss, Sensorineural, run by Johns Hopkins University at 5 sites in United States.
Trial summary
This observational study evaluates the effects of cochlear implantation in patients with deafness in one ear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Unilateral
- What is being tested?
- Cochlear implantation
- Type of treatment
- Medical device
- How many people
- 78 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Nov 2020to 9 Nov 2023
- How long will I take part?
- 1 Year
- 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: The study population comprises individuals with single-sided deafness or asymmetric hearing loss resulting in poor hearing in one ear.
Who may be able to join
- For individuals ages 18 years-old and above, limited benefit from unilateral amplification is defined by test scores of 5% correct or less on monosyllabic consonant-nucleus-consonant (CNC) words in quiet when tested in the ear to be implanted alone.
- Before implantation with a cochlear implant, individuals with SSD or AHL must have at least 1-month experience wearing a Contra Lateral Routing of Signal (CROS) hearing aid or other relevant device and not show any subjective benefit.
- Medical and surgical clearance for cochlear implantation.
Who cannot join
- Not meeting FDA candidacy criteria for cochlear implantation in SSD
- Inability to perform audiologic tasks (e.g. non-English speaking)
- Medical or surgical contraindication to general anesthesia or cochlear implant surgery
- Does not wish to participate
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins Bayview
Baltimore, Maryland, 21224
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287
Johns Hopkins Suburban
Bethesda, Maryland, 20814
Johns Hopkins Greenspring Station
Lutherville-Timonium, Maryland, 21093
Johns Hopkins White Marsh
Nottingham, Maryland, 21236
About this study
This observational study evaluates the effects of cochlear implantation in patients with deafness in one ear.
Read the detailed description
Cochlear implant (CI) technology has been widely used for individuals with bilateral sensorineural hearing loss to improve the ability to perceive sound by bypassing the damaged portion of the inner ear. Recently in the U.S., Cochlear implantation has also been approved by the FDA for treatment of single-sided deafness. By restoring binaural hearing, cochlear implantation in unilateral hearing loss may improve hearing in noise and sound localization, however its audiologic outcomes and quality of life impact for patients remain incompletely understood.
This study aims to establish a prospective database to track and quantify the change in general health status, tinnitus severity, spatial hearing ability, and difficulty with communication in noise after unilateral cochlear implantation in patients with SSD undergoing routine medical and audiologic evaluation at the Johns Hopkins Cochlear Implant Center. Study participants will complete survey questionnaires and undergo standard-of-care audiological evaluation before and after cochlear implantation. Data collected in this study will be invaluable in gaining an in-depth understanding of the effects of cochlear implantation in patients with SSD in the context of current FDA guidelines, and lead to better counseling and patient selection for this treatment modality.
- Conditions
- Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Unilateral, Hearing Loss, Sudden, Hearing Loss, Cochlear, Hearing Loss in Left Ear
- Being tested
- Cochlear implantation
- Keywords
- cochlear implantation
- Medical subject headings
- Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Unilateral, Hearing Loss, Sudden, Labyrinthitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear implantationDevice
Also called Med El cochlear implant
Patients who receive cochlear implant for single-sided deafness
| Study group | Role | What they receive |
|---|---|---|
| Cochlear implant recipients | Patients with single-sided deafness undergoing cochlear implantation Receives: Device: Cochlear implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Speech recognition in quiet
Change in Speech recognition in quiet will be assessed using the percent correct on Consonant-Noun-Consonant words and phonemes.
Measured: Baseline and up to 1 year post-implantation
Change in Speech recognition in noise
Change in Speech recognition in noise will be assessed using the percent correct on AzBio with multitalker babble at 8dB signal-to-noise ratio.
Measured: Baseline and up to 1 year post-implantation
Secondary outcomes (4)
Change in Spatial hearing as assessed by the Spatial Hearing Questionnaire
Score on Spatial Hearing Questionnaire. Range: 0-100. Higher score signifies less handicap related to sound localization.
Measured: Baseline and up to 1 year post-implantation
Change in Tinnitus handicap as assessed by the Tinnitus Handicap Inventory
Score on Tinnitus Handicap Inventory. Range: 0-100. Higher score signifies more handicap due to tinnitus.
Measured: Baseline and up to 1 year post-implantation
Change in Hearing aid benefit as assessed by the Abbreviated Profile of Hearing Aid Benefit
Score on Abbreviated Profile of Hearing Aid Benefit. Range: 0-100. Higher score signifies more frequent problems with hearing.
Measured: Baseline and up to 1 year post-implantation
Change in Health utility as assessed by the Health Utility Index
Score on Health Utility Index. Range: 0-1.0. Lower score signifies lower health utility.
Measured: Baseline and up to 1 year post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start19 Nov 2020
- Primary completion24 Jul 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- 78 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Sun, MD, Principal investigator, JHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052944
- Sponsor's protocol ID
- IRB00230644
- Status last verified
- Nov 2023
- First submitted
- 14 Sep 2021
- Last updated
- 13 Nov 2023
- Results posted
- 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 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-sided Deafness and Cochlear Implantation
- ClinicalTrials.gov ID
- NCT05052944
- Acronym / sponsor ID
- IRB00230644
- Conditions
- Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Unilateral, Hearing Loss, Sudden, Hearing Loss, Cochlear, Hearing Loss in Left Ear
- Keywords
- cochlear implantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 22 Sep 2021 (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.
This observational study evaluates the effects of cochlear implantation in patients with deafness in one ear.
Detailed description
Cochlear implant (CI) technology has been widely used for individuals with bilateral sensorineural hearing loss to improve the ability to perceive sound by bypassing the damaged portion of the inner ear. Recently in the U.S., Cochlear implantation has also been approved by the FDA for treatment of single-sided deafness. By restoring binaural hearing, cochlear implantation in unilateral hearing loss may improve hearing in noise and sound localization, however its audiologic outcomes and quality of life impact for patients remain incompletely understood.
This study aims to establish a prospective database to track and quantify the change in general health status, tinnitus severity, spatial hearing ability, and difficulty with communication in noise after unilateral cochlear implantation in patients with SSD undergoing routine medical and audiologic evaluation at the Johns Hopkins Cochlear Implant Center. Study participants will complete survey questionnaires and undergo standard-of-care audiological evaluation before and after cochlear implantation. Data collected in this study will be invaluable in gaining an in-depth understanding of the effects of cochlear implantation in patients with SSD in the context of current FDA guidelines, and lead to better counseling and patient selection for this treatment modality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear implant recipients | – | Device: Cochlear implantationPatients with single-sided deafness undergoing cochlear implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises individuals with single-sided deafness or asymmetric hearing loss resulting in poor hearing in one ear.
Key inclusion criteria (3 listed)
- For individuals ages 18 years-old and above, limited benefit from unilateral amplification is defined by test scores of 5% correct or less on monosyllabic consonant-nucleus-consonant (CNC) words in quiet when tested in the ear to be implanted alone.
- Before implantation with a cochlear implant, individuals with SSD or AHL must have at least 1-month experience wearing a Contra Lateral Routing of Signal (CROS) hearing aid or other relevant device and not show any subjective benefit.
- Medical and surgical clearance for cochlear implantation.
Key exclusion criteria (4 listed)
- Not meeting FDA candidacy criteria for cochlear implantation in SSD
- Inability to perform audiologic tasks (e.g. non-English speaking)
- Medical or surgical contraindication to general anesthesia or cochlear implant surgery
- Does not wish to participate
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 implantationAlso: Med El cochlear implantPatients who receive cochlear implant for single-sided deafness | Device | Cochlear implant recipients |
Primary outcome
Change in Speech recognition in quiet
Time frame: Baseline and up to 1 year post-implantation
Change in Speech recognition in quiet will be assessed using the percent correct on Consonant-Noun-Consonant words and phonemes.
Change in Speech recognition in noise
Time frame: Baseline and up to 1 year post-implantation
Change in Speech recognition in noise will be assessed using the percent correct on AzBio with multitalker babble at 8dB signal-to-noise ratio.
4 secondary outcomes
Change in Spatial hearing as assessed by the Spatial Hearing Questionnaire
Time frame: Baseline and up to 1 year post-implantation
Change in Tinnitus handicap as assessed by the Tinnitus Handicap Inventory
Time frame: Baseline and up to 1 year post-implantation
Change in Hearing aid benefit as assessed by the Abbreviated Profile of Hearing Aid Benefit
Time frame: Baseline and up to 1 year post-implantation
Change in Health utility as assessed by the Health Utility Index
Time frame: Baseline and up to 1 year post-implantation
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 13 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Daniel Sun, MD principal investigator
JHU
5 sites 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 and Hearing Loss, Sensorineural, run by Johns Hopkins University at 5 sites 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 3 inclusion and 4 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 Speech recognition in quiet (time frame: Baseline and up to 1 year post-implantation). 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 13 Nov 2023.