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slow enrolment
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The main purpose of this study is to monitor the response from the cochlea as the electrode is inserted during the operation to receive a cochlear implant. The Cochlear Response Telemetry tool aims to measure the response from the cells within the cochlea and may be useful in the future to help to improve the surgical technique and potentially help surgeons better preserve any natural hearing that is available. The measurements are obtained using the cochlear implant and sound processor while a sound is presented to the ear through an earphone (like an earplug) placed into the ear canal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear implant recipients | Other | Study group is comprised of cochlear implant patients already identified as candidates and undergoing surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear implant | Device | Study involves measuring using Electrocochleography to measure the CM response in patients undergoing cochlear implant surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively. | Average low-frequency (LF) hearing thresholds (average thresholds at 500, 750, and 1000 Hz) will be measured for the implanted ear 4 to 6 weeks following surgery and compared with average LF hearing thresholds measured relative to the pre-operative baseline measured within 90 days of CI surgery. The outcome measure of interest is the change in average LF hearing thresholds pre- to postoperative for each subject. The average change observed for individual subjects will then be compared with individual electrophysiological cochlear microphonic (CM) measures made during the surgery using the Cochlear Response Telemetry System. Of specific interest is whether or not compromised CM measures relate to pre-to-postoperative changes in low-frequency hearing. In other words, are larger changes in average LF hearing thresholds observed in subjects with compromised CM measures made intraoperative versus those with uncompromised CM response? | Baseline measurement (pre-operatively) compared to 4 to 6 weeks post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively. | Average low-frequency (LF) hearing thresholds (average thresholds at 500, 750, and 1000 Hz) will be measured for the implanted ear 3 months following cochlear implant activation and compared with average LF hearing thresholds measured preoperatively. The outcome measure of interest is the change in average LF hearing thresholds pre- to postoperative for each subject. The average change observed for individual subjects will then be compared with individual electrophysiological cochlear microphonic (CM) measures made during the surgery using the Cochlear Response Telemetry System. Of specific interest is whether or not compromised CM measures relate to pre-to-postoperative changes in low-frequency hearing. In other words, are larger changes in average LF hearing thresholds observed in subjects with compromised CM measures made intraoperative versus those with uncompromised CM response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adults Implanted With CI522, CI532, CI622, CI632 or Hybrid-L24 (US Only) | Adults (≥ 18 years of age) implanted with CI522, CI532, CI622, CI632 or Hybrid-L24 (US only) with pre-operative audiometric threshold in the ear to be implanted of better than or equal to 80 dB HL at the frequency of 500 Hz. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
19 data points were excluded from the analysis due to a number of reasons (outlined in the CIR), including that surgical intervention occurred during ECochG measurement for 3 patients invalidating the measures, ECochG measures were not captured intraoperatively for 5 patients, 3 patients received CI512 cochlear implant, one patient unable to undergo surgery, 7 patients had issues with the audiometric measurements.
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| ID | Title | Description |
|---|---|---|
| BG000 | Adults Implanted With CI522, CI532, CI622, CI632 or Hybrid-L24 (US Only) | Adults (≥ 18 years of age) implanted with CI522, CI532, CI622, CI632 or Hybrid-L24 (US only) with pre-operative audiometric threshold in the ear to be implanted of better than or equal to 80 dB HL at the frequency of 500 Hz. |
| 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 | Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively. | Average low-frequency (LF) hearing thresholds (average thresholds at 500, 750, and 1000 Hz) will be measured for the implanted ear 4 to 6 weeks following surgery and compared with average LF hearing thresholds measured relative to the pre-operative baseline measured within 90 days of CI surgery. The outcome measure of interest is the change in average LF hearing thresholds pre- to postoperative for each subject. The average change observed for individual subjects will then be compared with individual electrophysiological cochlear microphonic (CM) measures made during the surgery using the Cochlear Response Telemetry System. Of specific interest is whether or not compromised CM measures relate to pre-to-postoperative changes in low-frequency hearing. In other words, are larger changes in average LF hearing thresholds observed in subjects with compromised CM measures made intraoperative versus those with uncompromised CM response? | 19 of the 80 ECochG intro-operative responses were excluded from the analysis (reasons are outlined in the CIR). A further 18 of the remaining 61 data points were excluded due to an unclear CM response resulting in N=43 responses categorized as either preserved or compromised. Further, two subjects were excluded from the primary endpoint analysis as there were no FUV1 thresholds collected. Thereby N=41. | Posted | Mean | Full Range | dB | Baseline measurement (pre-operatively) compared to 4 to 6 weeks post-surgery |
5 months
Adverse events were collected for the subjects duration of involvement in the study - which was expected to be 5 months
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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 Recipients | Study group is comprised of cochlear implant patients already identified as candidates and undergoing surgery. Cochlear implant: Study involves measuring cochlear response electrophysiologically during surgery to place a cochlear implant in patients already identified as candidates. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SUDDEN ONSET ROTARY VERTIGO | Surgical and medical procedures | Systematic Assessment | PATIENT EXPERIENCED DIZZINESS, NAUSEA AND VOMITING AFTER POST-OP STENVERS X-RAY PROCEDURE DUE TO MANIPULATION TO GET GOOD IMAGE. DIZZINESS SETTLED AFTER ABOUT 1 HOUR. NAUSEA MAY BE RELATED TO CLINDAMYCIN POST-OP DOSE, DOSAGE CORRECTED. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COLD | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ruth English | Cochlear | 0386633105 | REnglish@cochlear.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 23, 2017 | Jan 23, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 29, 2019 | Aug 17, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D003054 | Cochlear Implants |
| ID | Term |
|---|---|
| D058117 | Neural Prostheses |
| D058542 | Implantable Neurostimulators |
| D004567 | Electrodes, Implanted |
| D004566 | Electrodes |
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| Baseline (pre-operative) compared to 3 months post cochlear implant activation |
| Correlation of Preoperative High-frequency Hearing Thresholds and Cochlear Microphonic Response (Number of Electrodes Inserted When CM Detected). | The onset of the cochlear microphonic (CM) response will be measured intraoperative to determine if there is a relationship between the onset of the CM response during electrode insertion and the preoperative high-frequency acoustic hearing thresholds. The onset of the CM response will be tracked by impedance measures that are interleaved with the CM recordings. As each electrode in the array enters the perilymph in the cochlea there will be a measured reduction in impedance. CM onset will be defined in terms of the nth electrode (out of the 22 electrodes) to enter the cochlea. Preoperative high-frequency hearing will be defined as the average of preoperative thresholds at frequencies of 2 kHz, 3 kHz and 4 kHz for each individual subject. | Intraoperative |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Device | Number | participants |
|
| AETIOLOGY | Number | participants |
|
| EAR (Left/Right | Number | participants |
|
| Nature of Hearing loss | Number | participants |
|
| Age of onset of hearing loss | No data from one patient in this study | Mean | Full Range | Years |
|
| Age of diagnosis Severe -Profound Hearing Loss | Total Analysis population=61 Subjects with No diagnosis=9 Subjects with No data =1 Hence, Measure Analysis Population=51 | Mean | Full Range | Years |
|
|
|
|
| Secondary | Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively. | Average low-frequency (LF) hearing thresholds (average thresholds at 500, 750, and 1000 Hz) will be measured for the implanted ear 3 months following cochlear implant activation and compared with average LF hearing thresholds measured preoperatively. The outcome measure of interest is the change in average LF hearing thresholds pre- to postoperative for each subject. The average change observed for individual subjects will then be compared with individual electrophysiological cochlear microphonic (CM) measures made during the surgery using the Cochlear Response Telemetry System. Of specific interest is whether or not compromised CM measures relate to pre-to-postoperative changes in low-frequency hearing. In other words, are larger changes in average LF hearing thresholds observed in subjects with compromised CM measures made intraoperative versus those with uncompromised CM response. | 5 data points were excluded from this analysis due to post-operative thresholds not being measured at FUV2 (43 - 5 = 38). | Posted | Mean | Full Range | dB | Baseline (pre-operative) compared to 3 months post cochlear implant activation |
|
|
|
| Secondary | Correlation of Preoperative High-frequency Hearing Thresholds and Cochlear Microphonic Response (Number of Electrodes Inserted When CM Detected). | The onset of the cochlear microphonic (CM) response will be measured intraoperative to determine if there is a relationship between the onset of the CM response during electrode insertion and the preoperative high-frequency acoustic hearing thresholds. The onset of the CM response will be tracked by impedance measures that are interleaved with the CM recordings. As each electrode in the array enters the perilymph in the cochlea there will be a measured reduction in impedance. CM onset will be defined in terms of the nth electrode (out of the 22 electrodes) to enter the cochlea. Preoperative high-frequency hearing will be defined as the average of preoperative thresholds at frequencies of 2 kHz, 3 kHz and 4 kHz for each individual subject. | 40 data points with a CM response were eligible to be analysed for this outcome. Those excluded were due to an absence of CM under visual inspection (n =16), an absence of the impedance measurement used to calculate depth (n = 4), or an array that was withdrawn or reinserted at any time (n = 5). | Posted | Number | Pearson correlation coefficient | Intraoperative |
|
|
|
| 0 |
| 61 |
| 2 |
| 61 |
| 15 |
| 61 |
|
| UNDISPLACED FRACTURE OF THE MEDIAL FEMORAL CONDYLE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| DELAYED FACIAL PARALYSIS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| VERTIGO AND NAUSEA | General disorders | Non-systematic Assessment |
|
| BRONCHITIS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| OTITIS MEDIA WITH EFFUSION | Ear and labyrinth disorders | Non-systematic Assessment |
|
| OTITIS EXTERNA DURING SURGERY | Ear and labyrinth disorders | Non-systematic Assessment |
|
| INTRAOPERATIVE HORIZONTAL CANAL DEFECT resulted in 'SEVERE VERTIGO EXPERIENCED DURING AUDIOMETRY, TY | General disorders | Systematic Assessment |
|
| PULSATILE TINNITUS | Ear and labyrinth disorders | Non-systematic Assessment |
|
| PAIN AND INFLAMATION POST SURGERY | Ear and labyrinth disorders | Non-systematic Assessment |
|
| EXACERBATION MENIERE'S DISEASE | Ear and labyrinth disorders | Non-systematic Assessment |
|
| BLOOD/FLUID STILL BEHIND EAR; NO PAIN REPORTED BY PATIENT | Ear and labyrinth disorders | Non-systematic Assessment |
|
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D055615 |
| Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
| D006310 | Hearing Aids |
| D012682 | Sensory Aids |