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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Cochlear Implant alone | Active Comparator | Subject only uses the cochlear implant; hearing on the contralateral side is unaided. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CROS | Device | Advanced Bionics CROS |
| |
| Hearing Aid |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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:
| 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:
|
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Inclusion Criteria*:
Exclusion Criteria*:
Non-English speakers
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| Name | Affiliation | Role |
|---|---|---|
| Melinda Anderson, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado School of Medicine | Aurora | Colorado | 80045 | United States |
De-identified data will be shared with Advanced Bionics.
From first patient through Institutional Review Board (IRB) study close.
The de-identified data will be shared to with Advanced Bionics in a password protected Excel sheet downloaded from research database.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cochlear Implant (CI) and Hearing Aid, Then CI and CROS, Then CI Alone |
|
| FG001 | Cochlear Implant (CI) and Hearing Aid, Then CI Alone, Then CI and CROS |
|
| FG002 | Cochlear Implant (CI) and CROS, Then CI and Hearing Aid, Then CI Alone. |
|
| FG003 | Cochlear Implant (CI) and CROS, Then CI Alone, Then CI and Hearing Aid |
|
| FG004 | Cochlear Implant (CI) Alone, Then CI and CROS, Then CI and Hearing Aid |
|
| FG005 | Cochlear Implant (CI) Alone, Then CI and Hearing Aid, Then CI and CROS |
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention 1 |
| ||||||||||||||||
| Intervention 2 |
| ||||||||||||||||
| Intervention 3 |
|
Demographics data and baseline measurements were only collected for participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants in crossover study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| One participant did not have data collected while wearing the contralateral device. Data is only available for 5 participants in the "No Contralateral Device" group. The PI has left the institution and multiple attempts to contact the PI or ascertain why only 5 participants were assessed for this group have been unsuccessful. This is the only data that can be provided. | Posted | Mean | Standard Deviation | ratio | 12 minutes |
5 Days
However, if a subject experiences an adverse event requiring medical attention, the patient will be offered treatment at the Otolaryngology Outpatient Clinic.
Any adverse events and/or Unanticipated Adverse Events will be treated using the standard of care for the specific problem.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cochlear Implant and Hearing Aid | 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. Hearing Aid: Advanced Bionics Naida hearing aid |
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A questionnaire related to listening effort and acceptability ratings was removed from the study and not collected. Outcome measures related to this questionnaire were not collected and have been removed from the record.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melinda Anderson | University of Colorado Anschutz SOM | 303-724-9316 | melinda.anderson@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2019 | Feb 13, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 17, 2019 | Dec 17, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| D003054 | Cochlear Implants |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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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.
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| Device |
Advanced Bionics Naida hearing aid |
|
| Cochlear Implant Alone | Other | No hearing device on contralateral ear |
|
| 12 minutes |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Implant Side | Count of Participants | Participants |
|
| Implant Device | Count of Participants | Participants |
|
| Contralateral Ear Device | Count of Participants | Participants |
|
| Has Tinnitus | Count of Participants | Participants |
|
| Tinnitus Frequency | Count of Participants | Participants |
|
| Tinnitus Ears | Count of Participants | Participants |
|
| Exposure to Excessive Noise | Count of Participants | Participants |
|
| Ear Protection with Excessive Noise | Count of Participants | Participants |
|
| Head Trauma | Count of Participants | Participants |
|
| Cognition/Memory Concern | Count of Participants | Participants |
|
| Diagnosis Related to Cognition/Memory | Count of Participants | Participants |
|
| Hearing loss duration (years) | Data was not collected for one participant | Mean | Standard Deviation | years |
|
| Years since first hearing aid fit | Data was not collected for one participant | Mean | Standard Deviation | years |
|
| Daily Use of Implant (hours) | Data was not collected for 4 participants | Mean | Standard Deviation | hours |
|
| Unaided Right PTA | Pure Tone Average (PTA) assesses the average of hearing threshold levels at a set of specified frequencies. It is measured in decibels. Normal hearing is about 0-25 decibels for sounds in the normal speech frequency range. | Data is missing for one participant. | Mean | Standard Deviation | dB |
|
| Unaided Left PTA | Pure Tone Average (PTA) assesses the average of hearing threshold levels at a set of specified frequencies. It is measured in decibels. Normal hearing is about 0-25 decibels for sounds in the normal speech frequency range. | Data is missing for one participant (could not be collected) | Mean | Standard Deviation | dB |
|
| PTA: Cochlear Implant Alone | Pure Tone Average (PTA) assesses the average of hearing threshold levels at a set of specified frequencies. It is measured in decibels. Normal hearing is about 0-25 decibels for sounds in the normal speech frequency range. | Data could not be collected for 3 participants. | Mean | Standard Deviation | dB |
|
| ID | Title | Description |
|---|---|---|
| OG000 | No Contralateral Device (Cochlear Implant Alone) | Subject only uses the cochlear implant; hearing on the contralateral side is unaided. Cochlear Implant Alone: No hearing device on contralateral ear |
| OG001 | Cochlear Implant and Contralateral Device | Subject wears a contralateral device |
|
|
| Primary | 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:
| One participant did not have data collected while wearing the contralateral device. Data is only available for 5 participants in the "No Contralateral Device" group. The PI has left the institution and multiple attempts to contact the PI or ascertain why only 5 participants were assessed for this group have been unsuccessful. This is the only data that can be provided. | Posted | Mean | Standard Deviation | ratio | 12 minutes |
|
|
|
| Primary | 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:
| Data could not be collected for one participant while wearing the Contralateral Device for condition "CIHA, Contra Speech, Omni Noise". Data is only available for 5 participants in the "No Contralateral Device" group. The PI has left the institution and multiple attempts to contact the PI or ascertain why only 5 participants were assessed for this group have been unsuccessful. This is the only data that can be provided. | Posted | Mean | Standard Deviation | ratio | 12 minutes |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Cochlear Implant Alone | Subject only uses the cochlear implant; hearing on the contralateral side is unaided. Cochlear Implant Alone: No hearing device on contralateral ear | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Cochlear Implant and CROS | Subject wears the CROS device on the contralateral side of the cochlear implant. Subject will use a clinic-loaned CROS device. CROS: Advanced Bionics CROS | 0 | 25 | 0 | 25 | 0 | 25 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
| D019736 | Prostheses and Implants |
| CICROS, Contra Speech, Omni |
|
| CICROS, Front Speech, Front Noise |
|
| CICROS, Front Speech, Omni Noise |
|
| CIHA, Contra Speech, Ipsi Noise |
|
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| CIHA, Contra Speech, Omni Noise |
|
|
| CIHA, Front Speech, Front Noise |
|
|
| CIHA, Front Speech, Omni Noise |
|
|