- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04707885
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Beth Miles-Markley
- Phone Number: 614-366-9244
- Email: beth.miles-markley@osumc.edu
Study Contact Backup
- Name: Meghan Hiss, AuD
- Email: meghan.hiss@osumc.edu
Study Locations
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Iowa
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Iowa City, Iowa, United States, 52242
- Recruiting
- University of Iowa
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Contact:
- Camille Dunn, PhD
- Email: camille-dunn@uiowa.edu
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Principal Investigator:
- Bruce Gantz, MD
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
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Contact:
- Paula Orr
- Email: orr.paula@mayo.edu
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Principal Investigator:
- Colin Driscoll, MD
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Missouri
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Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University in St. Louis
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Contact:
- Sarah Kukuljan
- Email: kukuljas@wustl.edu
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Principal Investigator:
- Amanda Ortmann, PhD
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Recruiting
- University of North Carolina, Chapel Hill
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Contact:
- Kevin Brown, MD
- Email: k_d_brown@med.unc.edu
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Principal Investigator:
- Kevin Brown, MD
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Ohio
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Columbus, Ohio, United States, 43210
- Recruiting
- Ohio State University Eye and Ear Institute
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Contact:
- Leah Kofmehl
- Email: Leah.Kofmehl@osumc.edu
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Principal Investigator:
- Edward Dodson, MD
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Tennessee
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Nashville, Tennessee, United States, 37232
- Recruiting
- Vanderbilt University
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Contact:
- Kenya Collins
- Email: kenya.collins.1@vumc.org
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Contact:
- Kelley Corcoran, AuD
- Email: kelley.corcoran@vumc.org
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Principal Investigator:
- Elizabeth Perkins, MD
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Medical College Of Wisconsin
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Contact:
- Sarah Mleziva
- Email: smleziva@mcw.edu
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Principal Investigator:
- Michael Harris, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Provision of signed and dated informed consent form.
- Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset.
- Minimum of 30 days experience with appropriately fit binaural amplification (standardized National Acoustic Laboratories (NAL) fitting method) verified with real ear measurements within 5 dB SPL of targets.
Limited benefit from conventional amplification in the best aided condition as defined by test scores of:
- The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio sentences (+10, +5 dB SNR ≤ 60% correct)
- Contralateral ear: ≤ 80% on CNC words or AzBio sentences (+10, +5 dB SNR ≤ 80% correct)
- Low frequency Pure Tone Average (PTA- 125, 250, 500 Hz) ≤ 55 dB HL in the ear to be implanted.
- Severe to profound mid to high-frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, and 4000 Hz ≥75 dB HL) in the ear to be implanted.
- Low frequency PTA ≤ 55 dB HL sloping to moderately severe to profound mid-to high frequency sensorineural hearing loss (threshold average of 1000, 2000, 3000, 4000 Hz ≥ 60 dB) in the contralateral ear.
- Proficient in English.
Undergoing implantation with a current generation CI device from either Cochlear Limited or Advanced Bionics AG.
- Cochlear Limited devices include: Nucleus CI612, CI622, CI632, CI624
- Advanced Bionics AG devices include: HiFocus SlimJ, Mid-Scala
- Stated willingness and ability to complete testing and all associated study visits.
Exclusion Criteria:
- Previous cochlear implantation.
- Prelingual onset of hearing loss.
- Abnormal inner ear anatomy on CT imaging.
- Auditory neuropathy spectrum disorder.
- Retrocochlear pathology such as a vestibular schwannoma or stroke.
- Unwillingness or inability to comply with all investigational requirements including the randomization process.
- Additional medical, or social barriers that would prevent completion of all study requirements.
- Medical condition contraindicated for surgery.
- Device selection of Med El CI (per the patient's selection).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ECochG monitoring
For those randomized to the experimental group, the CI surgery will proceed in a standard fashion.
However, the surgeon will utilize ECochG-guided monitoring by placing the external device coil and processor over the receiver/stimulator of the implanted components.
Also, a sound applicator (i.e.
speaker) will be placed in the external auditory canal by the surgeon.
During electrode insertion the surgeon will utilize the ECochG feedback to adjust insertion if needed.
That is, once the electrode has been inserted at least 75% (75% of the electrode contacts inside the cochlea), the surgeon may proceed to full insertion if indicated during ECochG feedback or may modify and/or cease electrode insertion if indicated by the ECochG feedback in attempts to preserve RH.
|
The use of ECochG monitoring will be employed. This will be conducted intraoperatively during the entire portion of the CI electrode insertion component. For the purposes of this clinical trial, the stimulus will consist of a 500 Hz tone burst presented at ~105-110 dB SPL. This was chosen due to the time and resource limitations in the operating room. Hence, the surgical team can only utilize a very limited dataset for intraoperative decision making and previous studies have demonstrated that 500 Hz stimulation offers the most robust, reliable, and useful ECochG signal during electrode insertions.
Other Names:
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No Intervention: Control Group
For those randomized to the control group, they will receive their CI per the standard of care.
That is, all procedures that take place during a routine CI surgery will be the same for those in the control group.
As such, no ECochG monitoring will be performed.
However, all study surgeons will be asked to adhere to soft surgical principles (non-traumatic cochlear opening, slow electrode insertions) to enhance HP outcomes even in the absence of intraoperative ECochG monitoring.
Further, the standard of care for cochlear implantation is to perform full electrode insertions with all electrode contacts inside of the cochlea.
Thus, for subjects in the control group, surgeons will be asked to perform full electrode insertions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Preservation Advantage
Time Frame: 3, 6, 12, 24 months
|
Determine the hearing preservation advantage, by measuring low tone audiometry at the 3, 6,12 and 24 month timepoints, in hertz.
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3, 6, 12, 24 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Oliver Adunka, MD, Ohio State University
- Principal Investigator: Amanda Ortmann, PhD, Washington University School of Medicine
Publications and helpful links
General Publications
- Gifford RH, Dorman MF, Shallop JK, Sydlowski SA. Evidence for the expansion of adult cochlear implant candidacy. Ear Hear. 2010 Apr;31(2):186-94. doi: 10.1097/AUD.0b013e3181c6b831.
- Pillsbury HC 3rd, Dillon MT, Buchman CA, Staecker H, Prentiss SM, Ruckenstein MJ, Bigelow DC, Telischi FF, Martinez DM, Runge CL, Friedland DR, Blevins NH, Larky JB, Alexiades G, Kaylie DM, Roland PS, Miyamoto RT, Backous DD, Warren FM, El-Kashlan HK, Slager HK, Reyes C, Racey AI, Adunka OF. Multicenter US Clinical Trial With an Electric-Acoustic Stimulation (EAS) System in Adults: Final Outcomes. Otol Neurotol. 2018 Mar;39(3):299-305. doi: 10.1097/MAO.0000000000001691.
- Koka K, Saoji AA, Litvak LM. Electrocochleography in Cochlear Implant Recipients With Residual Hearing: Comparison With Audiometric Thresholds. Ear Hear. 2017 May/Jun;38(3):e161-e167. doi: 10.1097/AUD.0000000000000385.
- Eggermont JJ. Ups and Downs in 75 Years of Electrocochleography. Front Syst Neurosci. 2017 Jan 24;11:2. doi: 10.3389/fnsys.2017.00002. eCollection 2017.
- Gantz BJ, Dunn C, Oleson J, Hansen M, Parkinson A, Turner C. Multicenter clinical trial of the Nucleus Hybrid S8 cochlear implant: Final outcomes. Laryngoscope. 2016 Apr;126(4):962-73. doi: 10.1002/lary.25572. Epub 2016 Jan 12.
- Gantz BJ, Hansen MR, Turner CW, Oleson JJ, Reiss LA, Parkinson AJ. Hybrid 10 clinical trial: preliminary results. Audiol Neurootol. 2009;14 Suppl 1(Suppl 1):32-8. doi: 10.1159/000206493. Epub 2009 Apr 22.
- Gautschi-Mills K, Khoza-Shangase K, Pillay D. Preservation of residual hearing after cochlear implant surgery: an exploration of residual hearing function in a group of recipients at cochlear implant units. Braz J Otorhinolaryngol. 2019 May-Jun;85(3):310-318. doi: 10.1016/j.bjorl.2018.02.006. Epub 2018 Mar 24.
- Gstoettner WK, Baumgartner WD, Franz P, Hamzavi J. Cochlear implant deep-insertion surgery. Laryngoscope. 1997 Apr;107(4):544-6. doi: 10.1097/00005537-199704000-00022. No abstract available.
- Gstoettner W, Helbig S, Settevendemie C, Baumann U, Wagenblast J, Arnoldner C. A new electrode for residual hearing preservation in cochlear implantation: first clinical results. Acta Otolaryngol. 2009 Apr;129(4):372-9. doi: 10.1080/00016480802552568.
- Campbell L, Kaicer A, Sly D, Iseli C, Wei B, Briggs R, O'Leary S. Intraoperative Real-time Cochlear Response Telemetry Predicts Hearing Preservation in Cochlear Implantation. Otol Neurotol. 2016 Apr;37(4):332-8. doi: 10.1097/MAO.0000000000000972.
- Harris MS, Riggs WJ, Giardina CK, O'Connell BP, Holder JT, Dwyer RT, Koka K, Labadie RF, Fitzpatrick DC, Adunka OF. Patterns Seen During Electrode Insertion Using Intracochlear Electrocochleography Obtained Directly Through a Cochlear Implant. Otol Neurotol. 2017 Dec;38(10):1415-1420. doi: 10.1097/MAO.0000000000001559.
- Hodges AV, Schloffman J, Balkany T. Conservation of residual hearing with cochlear implantation. Am J Otol. 1997 Mar;18(2):179-83.
- Lan KK, DeMets DL. Changing frequency of interim analysis in sequential monitoring. Biometrics. 1989 Sep;45(3):1017-20.
- Saoji AA, Patel NS, Carlson ML, Neff BA, Koka K, Tarigoppula VSA, Driscoll CLW. Multi-frequency Electrocochleography Measurements can be Used to Monitor and Optimize Electrode Placement During Cochlear Implant Surgery. Otol Neurotol. 2019 Dec;40(10):1287-1291. doi: 10.1097/MAO.0000000000002406.
- Scheperle RA, Tejani VD, Omtvedt JK, Brown CJ, Abbas PJ, Hansen MR, Gantz BJ, Oleson JJ, Ozanne MV. Delayed changes in auditory status in cochlear implant users with preserved acoustic hearing. Hear Res. 2017 Jul;350:45-57. doi: 10.1016/j.heares.2017.04.005. Epub 2017 Apr 12.
- Skinner MW, Holden TA, Whiting BR, Voie AH, Brunsden B, Neely JG, Saxon EA, Hullar TE, Finley CC. In vivo estimates of the position of advanced bionics electrode arrays in the human cochlea. Ann Otol Rhinol Laryngol Suppl. 2007 Apr;197:2-24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020H0477
- U01DC018920-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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