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| Name | Class |
|---|---|
| Med-El Corporation | INDUSTRY |
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Purpose: Routine clinical care and pilot study data has shown evidence of postoperative hearing preservation in pediatric cochlear implant (CI) recipients. The primary aim of this study is to investigate speech perception performance in pediatric CI recipients with functional pre-operative hearing.
Participants: Two cohorts of CI recipients aged 6 through 17 years who had pre-operative low frequency residual hearing. Subjects in Arm 1 (EAS Arm; electric-acoustic stimulation) will present with a post-operative low frequency pure tone average (125, 250, and 500 Hz) of ≤ 75 dB HL, and those in Arm 2 (FES Arm; full-electric stimulation) will present with a post-operative low frequency pure tone average (LFPTA) that exceeds 75 dB HL.
Procedures (methods): Subjects will complete speech perception and quality of life testing during post-operative intervals. Subjects in the EAS Arm will be evaluated with combined electric-acoustic stimulation (EAS). Subjects in FES Arm will be evaluated with FES alone.
As children with more residual hearing are receiving cochlear implants (CIs), there is an opportunity to preserve that hearing and provide combined electric and acoustic stimulation (EAS). The primary aim of this study is to investigate speech perception performance in pediatric CI recipients with functional pre-operative hearing. Specifically, the investigators intend to compare speech understanding using EAS and traditional full electric stimulation.
While hearing preservation rates are good, they are not guaranteed. Children with progressive hearing loss may continue to lose hearing, even if they maintain some residual hearing immediately after surgery. As a secondary aim, the investigators intend to study outcomes in children who do not maintain residual hearing and are fit with traditional CI programming methods. Children with more residual hearing are being implanted, and this study design allows validation of outcomes in both populations.
Subject enrollment will occur on the initial stimulation date. Those who have maintained a low frequency hearing average of 75 dB HL or better will be fit with a SONNET EAS or SONNET 2 EAS device using combined acoustic and electric stimulation. Those who have not maintained low frequency hearing will be fit with a SONNET EAS or SONNET 2 EAS device using electric stimulation only. Subjects will be followed at regular intervals throughout the year duration of the study and will be tested on measures of speech understanding in quiet, speech understanding in noise, quality of life, and discrimination of prosody or pitch changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EAS Arm | Experimental | Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: Electric-acoustic stimulation (EAS) fitting. |
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| FES Arm | Experimental | Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of > 75 dB HL. Electric Acoustic Speech Processor: Full-electric stimulation (FES) fitting |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting | Device | Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better, |
| Measure | Description | Time Frame |
|---|---|---|
| Mean CNC Word Scores | The Consonant Nucleus Consonant (CNC) word list is established as a standard test of speech perception outcomes. Results for EAS and FES Arms at 12 months post stimulation will be compared. Lower scores indicate a poorer outcome and higher scores a better outcome. Scale 0 - 100% | 12 months post stimulation |
| Mean BKB-SIN SNR-50 Scores | Sentences and babble will be presented from the same speaker. An average score known as the SNR-50 will be obtained in both conditions. The SNR-50 score is an estimate of the signal-to-noise ratio associated with 50% correct based on word-level scoring. Results for EAS and FES listeners at 12 months post stimulation will be compared. In this test, lower scores indicate a better outcome and higher scores a poorer outcome. Scores range from -6 dB to +21 dB. | 12 months post-stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pediatric SSQ Scores | The Speech, Spatial, and Qualities of Hearing (SSQ) Scale assesses performance in three domains, hearing speech in quiet and noise environments (9 items), spatial or directional hearing (5 items) and sound qualities (8 items), which address sound segregation and listening effort. Each item is rated on a 11-point scale, with 0 as the lowest possible performance and 10 as the highest. Domain scores represent an average of item ratings. There is a version for children that will be used for this study. Lower scores indicate a poorer outcome, and higher scores a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Park, AuD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Cochlear Implant Center at UNC | Durham | North Carolina | 27713-6102 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | EAS Arm | Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: EAS fitting. EAS fitting: Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better, |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | May 18, 2020 |
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| Electric Acoustic Speech Processor: Full-electric stimulation fitting | Device | Electric Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or poorer and pre-operative low frequency hearing averages of 75 dB HL or better. |
|
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| Baseline, 12 months post-stimulation |
| Receptive Language Scores | Mean receptive language scores as measured by the Oral and Written Language Scales, 2nd edition (OWLS II), comparing pre-operative scores to the 12 month test point for both groups. These tests are normed and reported as scaled scores. T-Scores scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome. A scores of 100 indicated the population mean with a standard deviation of 15. A score of 85 or poorer is indicative of a receptive language delay. | 12 months post-stimulation |
| Articulation Scores | Mean articulation scores as measured by the Goldman-Fristoe Test of Articulation, 3rd edition (GFTA3), comparing pre-operative scores to the 12 month test point for both groups. These tests are normed and reported as scaled scores. T-Scores scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome. A score of 100 indicates the population mean with a standard deviation of 15. A score of 85 or poorer is indicative of a articulation delay. | 12 months post-stimulation |
| Expressive Language Scores | Mean expressive language scores as measured by the Oral and Written Language Scales, 2nd edition (OWLS II), comparing pre-operative scores to the 12 month test point for both groups. These tests are normed and reported as scaled scores. T-Scores scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome. A score of 100 indicates the population mean with a standard deviation of 15. A score of 85 or poorer is indicative of an expressive language delay. | 12 months post-stimulation |
| FES Arm |
Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of > 75 dB HL. Electric Acoustic Speech Processor: FES fitting FES fitting: Full-electric stimulation for children with post-operative residual low frequency hearing averages greater than 75 dB HL and pre-operative low frequency hearing averages of 75 dB HL or better. |
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| ID | Title | Description |
|---|---|---|
| BG000 | EAS Arm | Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: EAS fitting: Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better. |
| BG001 | FES Arm | Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of > 75 dB HL. Electric Acoustic Speech Processor: Electric only fitting: Electric Stimulation for children with post-operative residual low frequency hearing averages greater than 75 dB HL and pre-operative low frequency hearing averages of 75 dB HL or better. |
| BG002 | Total | Total of all reporting groups |
| 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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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| Pre-operative Low Frequency Pure Tone Average (PTA) | Average hearing levels measured in decibels (dB) as measured at 125, 250, and 500 Hz | Mean | Standard Deviation | Decibels (dB) |
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| Post-operative Low Frequency Pure Tone Average (PTA) at Enrollment | Average of thresholds measured at 125, 250, and 500 Hz at enrollment. | Mean | Standard Deviation | Decibels (dB) |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean CNC Word Scores | The Consonant Nucleus Consonant (CNC) word list is established as a standard test of speech perception outcomes. Results for EAS and FES Arms at 12 months post stimulation will be compared. Lower scores indicate a poorer outcome and higher scores a better outcome. Scale 0 - 100% | Subjects who completed the 12-month protocol | Posted | Mean | Standard Deviation | Percent Correct | 12 months post stimulation |
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| Primary | Mean BKB-SIN SNR-50 Scores | Sentences and babble will be presented from the same speaker. An average score known as the SNR-50 will be obtained in both conditions. The SNR-50 score is an estimate of the signal-to-noise ratio associated with 50% correct based on word-level scoring. Results for EAS and FES listeners at 12 months post stimulation will be compared. In this test, lower scores indicate a better outcome and higher scores a poorer outcome. Scores range from -6 dB to +21 dB. | Subjects who completed the 12-month protocol | Posted | Mean | Standard Deviation | Signal to noise ratio (SNR) in decibels | 12 months post-stimulation |
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| Secondary | Mean Pediatric SSQ Scores | The Speech, Spatial, and Qualities of Hearing (SSQ) Scale assesses performance in three domains, hearing speech in quiet and noise environments (9 items), spatial or directional hearing (5 items) and sound qualities (8 items), which address sound segregation and listening effort. Each item is rated on a 11-point scale, with 0 as the lowest possible performance and 10 as the highest. Domain scores represent an average of item ratings. There is a version for children that will be used for this study. Lower scores indicate a poorer outcome, and higher scores a better outcome. | Subjects who completed the 12-month protocol | Posted | Mean | Standard Deviation | score on a scale | Baseline, 12 months post-stimulation |
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| Secondary | Receptive Language Scores | Mean receptive language scores as measured by the Oral and Written Language Scales, 2nd edition (OWLS II), comparing pre-operative scores to the 12 month test point for both groups. These tests are normed and reported as scaled scores. T-Scores scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome. A scores of 100 indicated the population mean with a standard deviation of 15. A score of 85 or poorer is indicative of a receptive language delay. | Not all participants were tested pre-operatively | Posted | Mean | Standard Deviation | T-score | 12 months post-stimulation |
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| Secondary | Articulation Scores | Mean articulation scores as measured by the Goldman-Fristoe Test of Articulation, 3rd edition (GFTA3), comparing pre-operative scores to the 12 month test point for both groups. These tests are normed and reported as scaled scores. T-Scores scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome. A score of 100 indicates the population mean with a standard deviation of 15. A score of 85 or poorer is indicative of a articulation delay. | Data reported for all subjects who completed pre-operative testing. | Posted | Mean | Standard Deviation | T-score | 12 months post-stimulation |
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| Secondary | Expressive Language Scores | Mean expressive language scores as measured by the Oral and Written Language Scales, 2nd edition (OWLS II), comparing pre-operative scores to the 12 month test point for both groups. These tests are normed and reported as scaled scores. T-Scores scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome. A score of 100 indicates the population mean with a standard deviation of 15. A score of 85 or poorer is indicative of an expressive language delay. | Not all subjects completed pre-operative testing | Posted | Mean | Standard Deviation | T-score | 12 months post-stimulation |
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From the time of signing informed consent through 12 months post-activation.
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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 | EAS Arm | Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: EAS fitting. Electric Acoustic Speech Processor: EAS fitting: Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better, | 0 | 16 | 0 | 16 | 1 | 16 |
| EG001 | FES Arm | Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of > 75 dB HL. Electric Acoustic Speech Processor: Electric only fitting: Electric Stimulation for children with post-operative residual low frequency hearing averages poorer than 75 dB HL and pre-operative low frequency hearing averages of 75 dB HL or better. | 0 | 12 | 0 | 12 | 0 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Ear and labyrinth disorders | Non-systematic Assessment | Subject reported a headache and pain with loud sound. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Park, AuD | The Children's Cochlear Implant Center at UNC | 919-419-1449 | lisa_park@med.unc.edu |
| May 13, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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