- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03134989
Cochlear Response Telemetry and Hearing Preservation (CREST)
August 30, 2021 updated by: Cochlear
Association Between Intra-Operative Cochlear Response Telemetry and Hearing Preservation
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Buenos Aires, Argentina
- Hospital Italiano de Buenos Aires
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Cochlear implant recipients
Study group is comprised of cochlear implant patients already identified as candidates and undergoing surgery.
|
Study involves measuring using Electrocochleography to measure the CM response in patients undergoing cochlear implant surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively.
Time Frame: Baseline measurement (pre-operatively) compared to 4 to 6 weeks post-surgery
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Low-frequency Hearing Thresholds Assessed Audiometrically Pre- and Post-operatively.
Time Frame: Baseline (pre-operative) compared to 3 months post cochlear implant activation
|
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.
|
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).
Time Frame: Intraoperative
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 22, 2017
Primary Completion (Actual)
June 18, 2020
Study Completion (Actual)
June 18, 2020
Study Registration Dates
First Submitted
April 19, 2017
First Submitted That Met QC Criteria
April 26, 2017
First Posted (Actual)
May 1, 2017
Study Record Updates
Last Update Posted (Actual)
September 24, 2021
Last Update Submitted That Met QC Criteria
August 30, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLTD5667
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hearing Impairment, Sensorineural
-
University of North Carolina, Chapel HillMed-El CorporationActive, not recruitingHigh Frequency Sensorineural Hearing Impairment | Hearing Disorders in ChildrenUnited States
-
Washington University School of MedicineNational Institute on Aging (NIA)CompletedHearing Impairment, SensorineuralUnited States
-
CochlearRecruitingHearing Impairment, SensorineuralBelgium, United States
-
University of Southern DenmarkInnovation Fund Denmark; William Demant FondenRecruitingHearing Loss, Sensorineural | Hearing Impairment, SensorineuralDenmark
-
CochlearAvaniaCompletedHearing Impairment, SensorineuralAustralia
-
Children's Hospital Medical Center, CincinnatiCompletedHearing Impairment | Sensorineural Hearing Loss, BilateralUnited States
-
Sunnybrook Health Sciences CentreRecruitingRehabilitation | Auditory; Nerve | Cochlear Implants | Hearing Impairment, SensorineuralCanada
-
Otonomy, Inc.CompletedSensorineural Hearing LossUnited States
-
Oticon MedicalNot yet recruitingSensorineural Hearing Loss, Bilateral | Sensorineural Hearing Loss, Severe | Sensorineural Hearing Loss, Profound
-
Otologics LLCUnknownMixed Conductive and Sensorineural Hearing Loss, Bilateral
Clinical Trials on Cochlear implant
-
University of North Carolina, Chapel HillMed-El CorporationCompletedMeniere's Disease | Unilateral Acoustic NeuromaUnited States
-
Nantes University HospitalRecruitingProfound Bilateral Hearing LossFrance
-
CochlearCompletedSingle Sided DeafnessUnited States
-
Western University, CanadaLawson Health Research Institute; Academic Medical Organization of Southwestern... and other collaboratorsRecruiting
-
MED-EL Elektromedizinische Geräte GesmbHRecruitingSensorineural Hearing Loss, BilateralFrance
-
Med-El CorporationTerminatedHearing LossUnited States, Canada
-
CochlearCompleted
-
University of NottinghamNottingham University Hospitals NHS TrustNot yet recruiting
-
University Hospital, AntwerpCochlearRecruitingHearing Loss, Unilateral | Cochlear Implants | Hearing Loss, Sensorineural, Severe | Hearing Loss, Sensorineural, Bilateral | Hearing Loss, Sensorineural, ProfoundBelgium