Back to resultsCochlear Response Telemetry and Hearing Preservation (CREST)
Primary Purpose
Hearing Impairment, Sensorineural
Status
Terminated
Phase
Locations
Argentina
Study Type
Interventional
Intervention
Cochlear implant
Sponsored by
About this trial
This is an interventional other trial for Hearing Impairment, Sensorineural focused on measuring cochlear implantation, electrocochleography
Eligibility Criteria
Inclusion Criteria:
- Candidate for cochlear implantation (with CI522, CI532, CI622, CI632 or Hybrid-L24 (US only) according to local indications
- 18 years of age or older at the time of enrolment
- Pre-operative audiometric threshold in the implanted ear at 500 Hz of better than or equal to 80 dB HL
- Willingness to participate in and to comply with all requirements of the protocol
Exclusion Criteria:
- Prior cochlear implantation in the ear to be implanted
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
- Abnormal cochlear/nerve anatomy on pre-operative CT or MRI imaging (excluding a mild Mondini malformation or Large Vestibular Aqueduct Syndrome)
- Deafness due to lesions of the acoustic nerve or central auditory pathway
- Diagnosis of auditory neuropathy
- Active middle-ear infection
- Additional handicaps that would prevent participation in evaluations
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device
Sites / Locations
- Hospital Italiano de Buenos Aires
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cochlear implant recipients
Arm Description
Study group is comprised of cochlear implant patients already identified as candidates and undergoing surgery.
Outcomes
Primary Outcome Measures
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?
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03134989
Brief Title
Cochlear Response Telemetry and Hearing Preservation
Acronym
CREST
Official Title
Association Between Intra-Operative Cochlear Response Telemetry and Hearing Preservation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
slow enrolment
Study Start Date
December 22, 2017 (Actual)
Primary Completion Date
June 18, 2020 (Actual)
Study Completion Date
June 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cochlear
4. Oversight
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impairment, Sensorineural
Keywords
cochlear implantation, electrocochleography
7. Study Design
Primary Purpose
Other
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cochlear implant recipients
Arm Type
Other
Arm Description
Study group is comprised of cochlear implant patients already identified as candidates and undergoing surgery.
Intervention Type
Device
Intervention Name(s)
Cochlear implant
Intervention Description
Study involves measuring using Electrocochleography to measure the CM response in patients undergoing cochlear implant surgery
Primary Outcome Measure Information:
Title
Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively.
Description
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?
Time Frame
Baseline measurement (pre-operatively) compared to 4 to 6 weeks post-surgery
Secondary Outcome Measure Information:
Title
Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively.
Description
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.
Time Frame
Baseline (pre-operative) compared to 3 months post cochlear implant activation
Title
Correlation of Preoperative High-frequency Hearing Thresholds and Cochlear Microphonic Response (Number of Electrodes Inserted When CM Detected).
Description
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.
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Candidate for cochlear implantation (with CI522, CI532, CI622, CI632 or Hybrid-L24 (US only) according to local indications
18 years of age or older at the time of enrolment
Pre-operative audiometric threshold in the implanted ear at 500 Hz of better than or equal to 80 dB HL
Willingness to participate in and to comply with all requirements of the protocol
Exclusion Criteria:
Prior cochlear implantation in the ear to be implanted
Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
Abnormal cochlear/nerve anatomy on pre-operative CT or MRI imaging (excluding a mild Mondini malformation or Large Vestibular Aqueduct Syndrome)
Deafness due to lesions of the acoustic nerve or central auditory pathway
Diagnosis of auditory neuropathy
Active middle-ear infection
Additional handicaps that would prevent participation in evaluations
Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
Country
Argentina
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cochlear Response Telemetry and Hearing Preservation
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