Hearing Loss, SensorineuralNCT03867396
Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear
A study testing CROS, Hearing Aid and Cochlear Implant Alone in people with Hearing Loss, Sensorineural, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Speech understanding in noise remains the greatest challenge for people using cochlear implants, particularly when the speech of interest comes from the side of the head opposite to the implant. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- CROS, Hearing Aid and Cochlear Implant Alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2019to 11 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An Advanced Bionics cochlear implant recipient with at least 6 months of listening experience
- Low frequency Pure Tone Audiometry (PTA)
Who cannot join
- Non-English speakers
- Additional Inclusion and Exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado School of Medicine
Aurora, Colorado, 80045
About this study
Official title: Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients Using Either a Conventional Hearing Aid or a CROS Device on the Contralateral Ear
Speech understanding in noise remains the greatest challenge for people using cochlear implants, particularly when the speech of interest comes from the side of the head opposite to the implant. Recent findings in hearing technology allow for people to either use a hearing aid or a Contralateral Routing of Signal (CROS) device on the non-implanted ear. Differences in speech understanding may result depending on the device chosen by a person, and these differences may be measureable through speech discrimination measurement methods.
This study intends to determine whether or not a CROS device improves speech perception in noise when the source of the speech of interest originates from the side of the head opposite to the implant.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- CROS, Hearing Aid, Cochlear Implant Alone
- Keywords
- Cochlear Implant, Hearing Loss, Hearing Aids, Hearing Tests
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CROSDevice
Advanced Bionics CROS
Hearing AidDevice
Advanced Bionics Naida hearing aid
Cochlear Implant AloneOther
No hearing device on contralateral ear
| Study group | Role | What they receive |
|---|---|---|
| Cochlear Implant and Hearing Aid | Active comparator | Subject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests. Receives: Device: Hearing Aid |
| Cochlear Implant alone | Active comparator | Subject only uses the cochlear implant; hearing on the contralateral side is unaided. Receives: Other: Cochlear Implant Alone |
| Cochlear Implant and CROS | Experimental | Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device. Receives: Device: CROS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #1 will assess how well the listener can hear with his/her cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows:
- Omni: from all directions
- Ipsi: the same side
- Front
- Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
Measured: 12 minutes
CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #2 will assess how well the listener can hear wearing his/her cochlear implant and a CROS (Contralateral Routing of Signals device). A CROS is a device on the opposite ear that sends the nose to the cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows:
- Omni: from all directions
- Ipsi: the same side
- Front
- Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
Measured: 12 minutes
CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #3 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows:
- Omni: from all directions
- Ipsi: the same side
- Front
- Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
Measured: 12 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start23 Jan 2019
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized into a group where they wear one of the processors and the order of conditions will be assessed, then they will switch to wear the other processor and the order of conditions will be assessed.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melinda Anderson, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867396
- Sponsor's protocol ID
- 18-1101
- Status last verified
- Apr 2022
- First submitted
- 19 Feb 2019
- Last updated
- 16 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data will be shared with Advanced Bionics.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients Using Either a Conventional Hearing Aid or a CROS Device on the Contralateral Ear
- ClinicalTrials.gov ID
- NCT03867396
- Acronym / sponsor ID
- 18-1101
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- Cochlear Implant, Hearing Loss, Hearing Aids, Hearing Tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 8 Mar 2019 (actual)
- Results
- Posted 16 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Speech understanding in noise remains the greatest challenge for people using cochlear implants, particularly when the speech of interest comes from the side of the head opposite to the implant. Recent findings in hearing technology allow for people to either use a hearing aid or a Contralateral Routing of Signal (CROS) device on the non-implanted ear. Differences in speech understanding may result depending on the device chosen by a person, and these differences may be measureable through speech discrimination measurement methods.
This study intends to determine whether or not a CROS device improves speech perception in noise when the source of the speech of interest originates from the side of the head opposite to the implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomized into a group where they wear one of the processors and the order of conditions will be assessed, then they will switch to wear the other processor and the order of conditions will be assessed.
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implant and Hearing Aid | Active comparator | Device: Hearing AidSubject wears a hearing aid on the contralateral side of the cochlear implant. Subject will use a clinic-loaned Naida hearing aid for listening tests. |
| Cochlear Implant alone | Active comparator | Other: Cochlear Implant AloneSubject only uses the cochlear implant; hearing on the contralateral side is unaided. |
| Cochlear Implant and CROS | Experimental | Device: CROSSubject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- An Advanced Bionics cochlear implant recipient with at least 6 months of listening experience
- Low frequency Pure Tone Audiometry (PTA)
Key exclusion criteria (2 listed)
- Non-English speakers
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 |
|---|---|---|
| CROSAdvanced Bionics CROS | Device | Cochlear Implant and CROS |
| Hearing AidAdvanced Bionics Naida hearing aid | Device | Cochlear Implant and Hearing Aid |
| Cochlear Implant AloneNo hearing device on contralateral ear | Other | Cochlear Implant alone |
Primary outcome
Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
Time frame: 12 minutes
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #1 will assess how well the listener can hear with his/her cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
CI CROS: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
Time frame: 12 minutes
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #2 will assess how well the listener can hear wearing his/her cochlear implant and a CROS (Contralateral Routing of Signals device). A CROS is a device on the opposite ear that sends the nose to the cochlear implant. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
CI HA: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test.
Time frame: 12 minutes
The IEEE test allows a researcher to evaluate how well a subject understands sentences in noisy situations. Primary Outcome #3 will assess how well the listener can hear wearing his/her cochlear implant and hearing aid. The listener will be tested without a contralateral device versus also wearing a contralateral device while listening to sentences coming from various directions along with competing noise coming from various directions. The directions of the sentences or noise are as follows: * Omni: from all directions * Ipsi: the same side * Front * Contra: Contralateral, from the opposite side of the implant Visits are flexible, based on participant preference and may be completed any time between enrollment and end of study. Testing takes about 12 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with Advanced Bionics.
Related trials for Hearing Loss, Sensorineural
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Otoferlin Gene-mediated Hearing Loss
Active, not recruiting
Performance of a Remote Microphone Compared to Hearing Aids Alone
Hearing Loss, Bilateral 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.
Melinda Anderson, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CROS, Hearing Aid and Cochlear Implant Alone in people with Hearing Loss, Sensorineural, run by University of Colorado, Denver 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 2 inclusion and 2 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 16 May 2022. 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?
Yes. Results are posted in the registry (first posted 16 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cochlear Implant: Signal to Noise Ratio (SNR) Threshold Obtained From IEEE (Speech Perception in Noise Test) Sentence in Noise Test. (time frame: 12 minutes). The study lists 3 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 16 May 2022.