Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.
Cochlear implantation is a highly effective method of rehabilitating hearing in individuals with severe to profound hearing loss. One current hurdle to optimising hearing outcomes following cochlear implantation is the unavoidable trauma caused to the inner ear during implant surgery. This damage can mean residual hearing that would remain valuable following implantation is lost. Various approaches have been trialed to preserve hearing during implantation surgery, modifying implantation technique and administering steroids. Electrocochleography (ECochG) is a monitoring technique that can be used during electrode insertion to record inner ear structural integrity and function.
The PRESERVE trial is an international, multi-centre, randomised controlled trial. The trial will randomly allocate adult cochlear implant recipients to undergo implantation surgery either with ECochG-guidance, or via the standard approach without guidance. Participants will be blinded, meaning they will not know which group they will be allocated to. Where ECochG is used, evidence of damage during insertion detected with the monitoring will trigger the surgeon to follow a corrective pathway. All other aspects of surgery and post operative care will follow standard clinical pathways for both groups.
Participants will have their natural hearing measured preoperatively, and 3- and 6-months following implant activation. The change in natural hearing thresholds at different frequencies, and the degree of hearing preservation will then be calculated and compared between the standard surgery and ECochG-guided group. Using their cochlear implant, understanding of speech will also be measured and compared between groups. In addition, participants will undergo a second CT scan following implantation surgery, and this will be compared to the routine pre-operative imaging to assess both the location of the implant electrode, and structural preservation of the cochlear. Throughout the study participants will remain under the care of their routine medical team.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | ECochG monitored CI surgery incl. corrective action guide |
|
| Control | Active Comparator | Routine CI surgery without ECochG monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECochG monitored CI surgery incl. corrective action guide | Procedure | Interventional surgery with surgeon having access to intra-operative ECochG monitoring feedback to deploy ECochG based corrective action guide |
| Measure | Description | Time Frame |
|---|---|---|
| Hearing Preservation | Difference in dB (absolute) and % (relative) in low-frequency hearing preservation measured via air conduction pure tone audiometry | From pre-operative to 6 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Structure Preservation | Difference in mm of structure preservation (distance from electrode contact to basilar membrane) via radiological assessment of the position of the electrode array | 1 month post-operative |
| Speech perception |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeons' feedback | Qualitative feedback on surgical experience measured via a questionnaire | Through study completion, an average of 2.5 years |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Unai Martinez de Estibariz, Mr | Contact | +34666964128 | unai.martinez@advancedbionics.com | |
| Martina Brendel, Ms | Contact | +4915222836491 | martina.brendel@advancedbionics.com |
| Name | Affiliation | Role |
|---|---|---|
| Matt E Smith, Dr | Cambridge University Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Gent | Recruiting | Ghent | Gent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34600798 | Background | Bester C, Collins A, Razmovski T, Weder S, Briggs RJ, Wei B, Zakaria AF, Gerard JM, Mitchell-Innes A, Tykocinski M, Kennedy R, Iseli C, Dahm M, Ellul S, O'Leary S. Electrocochleography triggered intervention successfully preserves residual hearing during cochlear implantation: Results of a randomised clinical trial. Hear Res. 2022 Dec;426:108353. doi: 10.1016/j.heares.2021.108353. Epub 2021 Sep 20. | |
| 35452461 |
| Label | URL |
|---|---|
| Cochlear implants for children and adults with severe to profound deafness - Technology appraisal guidance \[TA566\] | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Routine CI surgery without ECochG monitoring | Procedure | Routine CI surgery with access to ECochG monitoring by surgeon |
|
Difference in speech perception scores in both quiet (%) and noise (dB SNR) using the International Matrix Test
| From pre-operative to 6 months post-operative |
| Le Centre Hospitalier Régional Universitaire de Tours | Recruiting | Tours | Tours | 37000 | France |
|
| Universitätsklinikum Freiburg Klinik | Recruiting | Freiburg im Breisgau | Freiburg | 79106 | Germany |
|
| Ospedale Martini | Recruiting | Torino | TO | 10141 | Italy |
|
| World Hearing Center | Recruiting | Warsaw | Nadarzyn | 05-830 | Poland |
|
| Hospital Universitario Clinico San Cecilio | Recruiting | Granada | Granada | 18007 | Spain |
|
| Cambridge University Hospitals NHS Foundation Trust | Recruiting | Cambridge | England | CB2 0QQ | United Kingdom |
|
| Background |
| Buechner A, Bardt M, Haumann S, Geissler G, Salcher R, Lenarz T. Clinical experiences with intraoperative electrocochleography in cochlear implant recipients and its potential to reduce insertion trauma and improve postoperative hearing preservation. PLoS One. 2022 Apr 22;17(4):e0266077. doi: 10.1371/journal.pone.0266077. eCollection 2022. |
| 21659922 | Background | Carlson ML, Driscoll CL, Gifford RH, Service GJ, Tombers NM, Hughes-Borst BJ, Neff BA, Beatty CW. Implications of minimizing trauma during conventional cochlear implantation. Otol Neurotol. 2011 Aug;32(6):962-8. doi: 10.1097/MAO.0b013e3182204526. |
| 25839980 | Background | Dalbert A, Sim JH, Gerig R, Pfiffner F, Roosli C, Huber A. Correlation of Electrophysiological Properties and Hearing Preservation in Cochlear Implant Patients. Otol Neurotol. 2015 Aug;36(7):1172-80. doi: 10.1097/MAO.0000000000000768. |
| 30113557 | Background | Koka K, Riggs WJ, Dwyer R, Holder JT, Noble JH, Dawant BM, Ortmann A, Valenzuela CV, Mattingly JK, Harris MM, O'Connell BP, Litvak LM, Adunka OF, Buchman CA, Labadie RF. Intra-Cochlear Electrocochleography During Cochear Implant Electrode Insertion Is Predictive of Final Scalar Location. Otol Neurotol. 2018 Sep;39(8):e654-e659. doi: 10.1097/MAO.0000000000001906. |
| 30335669 | Background | Giardina CK, Brown KD, Adunka OF, Buchman CA, Hutson KA, Pillsbury HC, Fitzpatrick DC. Intracochlear Electrocochleography: Response Patterns During Cochlear Implantation and Hearing Preservation. Ear Hear. 2019 Jul/Aug;40(4):833-848. doi: 10.1097/AUD.0000000000000659. |
| 23446225 | Background | Gifford RH, Dorman MF, Skarzynski H, Lorens A, Polak M, Driscoll CL, Roland P, Buchman CA. Cochlear implantation with hearing preservation yields significant benefit for speech recognition in complex listening environments. Ear Hear. 2013 Jul-Aug;34(4):413-25. doi: 10.1097/AUD.0b013e31827e8163. |
| 30741914 | Background | Lenarz T, Timm ME, Salcher R, Buchner A. Individual Hearing Preservation Cochlear Implantation Using the Concept of Partial Insertion. Otol Neurotol. 2019 Mar;40(3):e326-e335. doi: 10.1097/MAO.0000000000002127. |
| 36395515 | Background | O'Leary S, Mylanus E, Venail F, Lenarz T, Birman C, Di Lella F, Roland JT Jr, Gantz B, Beynon A, Sicard M, Buechner A, Lai WK, Boccio C, Choudhury B, Tejani VD, Plant K, English R, Arts R, Bester C. Monitoring Cochlear Health With Intracochlear Electrocochleography During Cochlear Implantation: Findings From an International Clinical Investigation. Ear Hear. 2023 Mar-Apr 01;44(2):358-370. doi: 10.1097/AUD.0000000000001288. Epub 2022 Nov 8. |
| 31644474 | Background | 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. |
| 35629304 | Background | Skarzynski PH, Lorens A, Walkowiak A, Polak M, Skarzynski H. Multi-Frequency Intraoperative Monitoring of Hearing Preservation during Cochlear Implantation. Life (Basel). 2022 Apr 25;12(5):636. doi: 10.3390/life12050636. |
| 27755369 | Background | Verberne J, Risi F, Campbell L, Chambers S, O'Leary S. The Effect of Scala Tympani Morphology on Basilar Membrane Contact With a Straight Electrode Array: A Human Temporal Bone Study. Otol Neurotol. 2017 Jan;38(1):47-53. doi: 10.1097/MAO.0000000000001259. |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |