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| ID | Type | Description | Link |
|---|---|---|---|
| R21DC018389 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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Purpose: Investigate monaural and binaural hearing in electric-acoustic stimulation (EAS) users with place-based versus default maps.
Participants: Cochlear implant recipients and normal-hearing listeners Procedures (methods): This is a prospective, longitudinal investigation of the monaural and binaural outcomes (such as speech perception, spatial hearing, and/or subjective benefit) of cochlear implant recipients listening with different programs. The programs will incorporate different patient and device variables to determine the effect on cochlear implant recipient outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear implant participants with Default maps | Other | The default frequency filters assigned by the clinical software |
|
| Cochlear implant participants with Place-Based maps | Experimental | Frequency filters adjusted to align with the cochlear place frequency |
|
| Normal hearing controls listening to simulations | Other | Normal hearing controls listening to simulations of default and place-based maps. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| place-based mapping | Other | Adjusting the electric frequency filters to align with the cochlear place frequency |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time | Monaural perception (e.g., word recognition in quiet) will be assessed at defined intervals (e.g., activation, and 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps). | Up to 12 months post-activation |
| Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front) | Binaural hearing abilities (e.g., spatial release from masking) will be assessed at defined intervals (e.g., 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps). | Up to 12 months post-activation |
| Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front) | Binaural hearing abilities (e.g., spatial release from masking) will be assessed at defined intervals (e.g., 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps). | Up to 12 months post-activation |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Abilities Over Time | Perceived abilities will be assessed with questionnaires (e.g., Speech, Spatial, and Qualities of hearing scale; SSQ) at defined intervals (e.g., activation, and 1, 3, 6, and 12 months post-activation). A subject indicates his/her perceived abilities for each question on the SSQ using a Likert scale, with a range of 0-10 (with 10 indicating better perceived abilities). Responses will be compared between group over the study intervals. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps). |
| Measure | Description | Time Frame |
|---|---|---|
| Word Recognition With Default Versus Place-based Maps for Participants With Normal Hearing | Participants with normal hearing (Arm 3) listening to simulations of default versus place-based maps. All procedures completed at baseline (one visit that was ~ 20 minutes in duration). There were no follow-up visits. | All procedures completed at baseline (one visit that was ~ 20 minutes in duration). |
Cochlear implant participants
Inclusion Criteria:
Exclusion Criteria:
Normal-hearing controls
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret T Dillon, AuD, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Kevin D Brown, MD, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC ENT at Carolina Crossing | Chapel Hill | North Carolina | 27517 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36800505 | Result | Dillon MT, Canfarotta MW, Buss E, Rooth MA, Richter ME, Overton AB, Roth NE, Dillon SM, Raymond JH, Young A, Pearson AC, Davis AG, Dedmon MM, Brown KD, O'Connell BP. Influence of Electric Frequency-to-Place Mismatches on the Early Speech Recognition Outcomes for Electric-Acoustic Stimulation Users. Am J Audiol. 2023 Mar;32(1):251-260. doi: 10.1044/2022_AJA-21-00254. Epub 2023 Feb 17. | |
| 35394798 | Result | Dillon MT, O'Connell BP, Canfarotta MW, Buss E, Hopfinger J. Effect of Place-Based Versus Default Mapping Procedures on Masked Speech Recognition: Simulations of Cochlear Implant Alone and Electric-Acoustic Stimulation. Am J Audiol. 2022 Jun 2;31(2):322-337. doi: 10.1044/2022_AJA-21-00123. Epub 2022 Apr 8. |
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Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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beginning 9 to 36 months following publication
Investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.
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Participants with cochlear implants were randomized to one of two groups (arms): Arm 1 (default maps) or Arm 2 (place-based maps)
Participants with normal hearing (Arm 3; control group) listened to simulations of default and place-based maps.
Three study arms: 1) Participants with a cochlear implant randomized to listen with a default map (Arm 1), 2) Participants with a cochlear implant randomized to listen with a place-based map, and 3) Participants with normal hearing who listened to simulations of both maps (control group).
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| ID | Title | Description |
|---|---|---|
| FG000 | Default | The default frequency filters assigned by the clinical software default mapping: Default frequency filter assignments |
| FG001 | Place-based | Frequency filters adjusted to align with the cochlear place frequency place-based mapping: Adjusting the electric frequency filters to align with the cochlear place frequency |
| FG002 | Normal Hearing Control | age-matched listeners with normal hearing in both ears |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Default | The default frequency filters assigned by the clinical software default mapping: Default frequency filter assignments |
| BG001 | Place-based | Frequency filters adjusted to align with the cochlear place frequency place-based mapping: Adjusting the electric frequency filters to align with the cochlear place frequency |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time | Monaural perception (e.g., word recognition in quiet) will be assessed at defined intervals (e.g., activation, and 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps). | This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps). | Posted | Mean | Standard Deviation | percent of words correctly repeated | Up to 12 months post-activation |
|
1 year from cochlear implant activation for participants in Arms 1 and 2. Participants in Arms 1 and 2 were cochlear implant recipients who were followed for 1 year after cochlear implant activation. Single visit (baseline) for participants in Arm 3. Participants in Arm 3 had normal hearing and listened to simulations of default and place-based maps during one visit.
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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 Users With Default Maps | The default frequency filters assigned by the clinical software default mapping: Default frequency filter assignments |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Dillon, AuD, PhD | University of North Carolina at Chapel Hill | 919-966-5251 | mdillon@med.unc.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 | Feb 17, 2025 | Feb 25, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 31, 2023 | Jul 23, 2024 | ICF_000.pdf |
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Subjects will be randomized to one of two groups.
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Participant and testing audiologist were blinded to the randomized map for Arm 1 (cochlear implant users with default maps) and Arm 2 (cochlear implant users with place-based maps). Arm 3 is normal hearing participants listening to simulations of default and place-based maps.
| default mapping | Other | Default frequency filter assignments |
|
| Up to 12 months post-activation |
| Vowel Recognition for Participants With Normal Hearing | Vowel recognition for participants with normal hearing controls listening to simulations of default versus place-based maps. All procedures completed at baseline (one visit that was ~ 20 minutes in duration). There were no additional visits. | All procedures completed at baseline (one visit that was ~ 20 minutes in duration). |
| Sentence Understanding in Noise for Participants With Normal Hearing | Sentence understanding in noise for participants with normal hearing controls listening to simulations of default versus place-based maps All procedures completed at baseline (one visit that was ~ 20 minutes in duration). There were no additional visits. | All procedures completed at baseline (one visit that was ~ 20 minutes in duration). |
| 33885267 | Result | Dillon MT, Canfarotta MW, Buss E, Hopfinger J, O'Connell BP. Effectiveness of Place-based Mapping in Electric-Acoustic Stimulation Devices. Otol Neurotol. 2021 Jan;42(1):197-202. doi: 10.1097/MAO.0000000000002965. |
| BG002 | Normal Hearing Control Group | age-matched listeners with normal hearing in both ears |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Unaided Threshold at 125 Hz | Mean | Standard Deviation | decibels |
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| OG001 | Place-based | Frequency filters adjusted to align with the cochlear place frequency place-based mapping: Adjusting the electric frequency filters to align with the cochlear place frequency |
|
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| Primary | Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front) | Binaural hearing abilities (e.g., spatial release from masking) will be assessed at defined intervals (e.g., 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps). | This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps). | Posted | Mean | Standard Deviation | percent of words correctly repeated | Up to 12 months post-activation |
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| Primary | Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front) | Binaural hearing abilities (e.g., spatial release from masking) will be assessed at defined intervals (e.g., 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps). | This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps). | Posted | Mean | Standard Deviation | percent of words correctly repeated | Up to 12 months post-activation |
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| Secondary | Perceived Abilities Over Time | Perceived abilities will be assessed with questionnaires (e.g., Speech, Spatial, and Qualities of hearing scale; SSQ) at defined intervals (e.g., activation, and 1, 3, 6, and 12 months post-activation). A subject indicates his/her perceived abilities for each question on the SSQ using a Likert scale, with a range of 0-10 (with 10 indicating better perceived abilities). Responses will be compared between group over the study intervals. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps). | This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps). One participant in the place-based group did not complete the SSQ questionnaire at the 6 month post-activation visit. | Posted | Mean | Standard Deviation | score on scale of 1 (worst) to 10 (best) | Up to 12 months post-activation |
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| Other Pre-specified | Word Recognition With Default Versus Place-based Maps for Participants With Normal Hearing | Participants with normal hearing (Arm 3) listening to simulations of default versus place-based maps. All procedures completed at baseline (one visit that was ~ 20 minutes in duration). There were no follow-up visits. | Arm 3: Participants with normal hearing listening to simulations of default versus place-based maps One participant did not complete this task | Posted | Mean | Standard Error | percent of words correctly repeated | All procedures completed at baseline (one visit that was ~ 20 minutes in duration). |
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| Other Pre-specified | Vowel Recognition for Participants With Normal Hearing | Vowel recognition for participants with normal hearing controls listening to simulations of default versus place-based maps. All procedures completed at baseline (one visit that was ~ 20 minutes in duration). There were no additional visits. | Arm 3: Participants with normal hearing listening to simulations of default versus place-based maps | Posted | Mean | Standard Deviation | percent of vowels correctly repeated | All procedures completed at baseline (one visit that was ~ 20 minutes in duration). |
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| Other Pre-specified | Sentence Understanding in Noise for Participants With Normal Hearing | Sentence understanding in noise for participants with normal hearing controls listening to simulations of default versus place-based maps All procedures completed at baseline (one visit that was ~ 20 minutes in duration). There were no additional visits. | Arm 3: Participants with normal hearing listening to simulations of default versus place-based maps | Posted | Mean | Standard Deviation | percent of words correctly repeated | All procedures completed at baseline (one visit that was ~ 20 minutes in duration). |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Cochlear Implant Users With Place-based Maps | Frequency filters adjusted to align with the cochlear place frequency place-based mapping: Adjusting the electric frequency filters to align with the cochlear place frequency | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Normal Hearing Controls | Normal hearing participants listening to simulations of default and place-based maps. | 0 | 15 | 0 | 15 | 0 | 15 |
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| 6 month |
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| 12 month |
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| 6 month |
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| 12 month |
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| 1 month |
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| 3 months |
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| 6 months |
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| 12 months |
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