Hearing Loss Clinical Trial
— IROSOfficial title:
Cochlear-Implanted Recipient Observational Study
NCT number | NCT02004353 |
Other study ID # | CEL 5277 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | July 2011 |
Est. completion date | July 31, 2020 |
Verified date | November 2020 |
Source | Cochlear |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The purpose of this study is to collect patient related benefit data following treatment for permanent hearing loss with a hearing implant from the company Cochlear over a period of 2 years post treatment. Assessment of benefits is based on standard questionnaires of hearing ability and quality of life in general.
Status | Terminated |
Enrollment | 1518 |
Est. completion date | July 31, 2020 |
Est. primary completion date | June 23, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years and older |
Eligibility | Inclusion Criteria: - Post-lingually deafened adults and adolescents who are newly implanted AND prior to first switch-on of their external device - Unilateral, bilateral simultaneous recipients of any implant device(s) available with market approval from the company Cochlear® - Children 10 years or older and in accordance with local regulations and product labelling - Mentally capable to respond to self-administered assessment scales - Willingness to participate and sign the Patient Informed Consent form Exclusion Criteria: - Individuals excluded from participation in a registry according to national or local regulations |
Country | Name | City | State |
---|---|---|---|
Argentina | Centro de Implantes Cocleares | Buenos Aires | |
Argentina | Implantes Cocleares Equipo Multicentrico (ICEM) | Buenos Aires | |
Argentina | Centro de Investigaciones Otoaudiologicas (CIOA) | Caba | |
Argentina | Clinca Reina Fabiola | Córdoba | |
Austria | Landesklinikum St. Pölten | St. Pölten | |
Belgium | University Hospital Leuven | Leuven | |
Brazil | Hospital Edmundo Vasconcelos | Sao Paulo | |
Colombia | Clinica Orlant | Antioquia | |
Colombia | Te Oigo | Barranquilla | |
Colombia | Clinica Rivas | Bogota | |
Colombia | Consultorio Gutierrez | Bogota | |
Colombia | Consultorio Navarro | Bogota | |
Colombia | Consultorio Ordonez | Bogota | |
Colombia | DIAUDIO | Bogota | |
Colombia | Hospital de la Policia | Bogota | |
Colombia | Hospital San Jose Infantil | Bogota | |
Colombia | Hospital Universitario Clinica San Rafael | Bogota | |
Colombia | Mediglobal | Bogota | |
Colombia | Consultório Plaza | Bogotá | |
Colombia | Consultorio Prieto | Bogotá | |
Colombia | Disaudio | Bogotá | |
Colombia | Instituto Nacional de Otologia Garcia Gomez | Bogotá | |
Colombia | Instituto para Niños Ciegos y Sordos | Cali | |
Colombia | Consultório Velez | Cartagena | |
Colombia | Consultório Mosquera | Ibague | |
Colombia | Consultorio Jaramillo | Manizales | |
Colombia | Hospital Santa Sofia | Manizales | |
Colombia | Clinica Sagrada Familia | Quindio | |
Colombia | IPS San Rafael | Risaralda | |
Colombia | Audiomedica | Santander | |
Colombia | Consultorio Torres | Zipaquira | |
France | CHRU Lille | Lille | |
Germany | HNO Bad Aibling | Bad Aibling | |
Germany | Universitäts-Hals-Nasen-Ohren-Klinik Essen | Essen | |
Germany | Universitätsklinikum Frankfurt | Frankfurt am Main | |
Germany | Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde | Freiburg | |
Germany | KMG Kliniken GmbH Güstrow | Güstrow | |
Germany | Medizinische Hochschule Hannover | Hannover | |
Germany | Helios München West | Münich | |
Germany | Eberhard-Karls-Universität Tübingen | Tübingen | |
Germany | Universitätsklinikum Ulm | Ulm | |
Germany | University of Wuerzburg | Wuerzburg | |
Hungary | University of Szeged | Szeged | |
Netherlands | Radboud University | Nijmegen | |
Poland | Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok | |
Poland | Szpital Uniwersytecki nr 2 w Bydgoszczy | Bydgoszcz | |
Poland | Wojewodzki Szpital Dzieciecy w Bydgoszczy | Bydgoszcz | |
Poland | World Hearing Center | Kajetany | |
Poland | Wojewodzki Szpital Zespolony w Koninie | Konin | |
Poland | Instytut Centrum Zdrowia Matki Polki w Lodzi | Lodz | |
Poland | Uniwersytecki Szpital Kliniczny nr 1 w Lodzi | Lodz | |
Poland | Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie | Lublin | |
Poland | Wojewodzkie Centrum Medyczne w Opolu | Opole | |
Poland | Samodzielny Publiczny Szpital Kliniczny nr 2 w Poznaniu | Poznan | |
Poland | Samodzielny Publiczny Szpital Kliniczny nr 1 w Szczecinie | Szczecin | |
Portugal | CUF Infante Santo Hospital | Lisbon | |
Portugal | Hospital Lusiadas Lisboa | Lisbon | |
Portugal | Hospital CUF Porto | Porto | |
Slovenia | UKC Maribor | Maribor | |
South Africa | Stellenbosch University | Cape Town | |
South Africa | Durban Cochlear Implant Pogramme, Parklands Hospital | Durban | |
South Africa | Johannesburg Cochlear Implant Center, Wits Donald Gordon Medical Centre | Johannesburg | |
Spain | Hospital de la Ribera | Alzira | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | Hospital San Pedro de Alcantara | Caceres | |
Spain | Fundacion Jimenez Diaz | Madrid | |
Spain | Hospital General Universitario Gregorio Maranon | Madrid | |
Spain | Hospital Clinica Universitad de Navarra | Pamplona | |
Spain | Hospital Clinico Universitario de Salamanca | Salamanca | |
Spain | Hospital Donostia | San Sebastian | |
Spain | Hospital Clinico Universitario de Valencia | Valencia | |
Spain | Hospital Universitario del Rio Hortega | Valladolid | |
Spain | Hospital Clinico Universitario Lozano Blesa | Zaragoza | |
Sweden | Karolinska Hospital Huddinge | Stockholm | |
Turkey | Osmangazi University Hospital | Eskisehir | |
Turkey | Cerrahpasa University Hospital | Istanbul | |
Turkey | Marmara University Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Cochlear |
Argentina, Austria, Belgium, Brazil, Colombia, France, Germany, Hungary, Netherlands, Poland, Portugal, Slovenia, South Africa, Spain, Sweden, Turkey,
Maes IH, Joore MA, Cima RF, Vlaeyen JW, Anteunis LJ. Assessment of health state in patients with tinnitus: a comparison of the EQ-5D and HUI mark III. Ear Hear. 2011 Jul-Aug;32(4):428-35. doi: 10.1097/AUD.0b013e3181fdf09f. — View Citation
Noble W, Tyler R, Dunn C, Bhullar N. Unilateral and bilateral cochlear implants and the implant-plus-hearing-aid profile: comparing self-assessed and measured abilities. Int J Audiol. 2008 Aug;47(8):505-14. doi: 10.1080/14992020802070770. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire | A scale from 0 to 10 is used, where 0 represents "can not hear at all" and 10 "hear perfectly". The change from baseline to post-implant at 1 year is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing. | Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year | |
Primary | Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire | A scale from 0 to 10 is used, where 0 represents "can not hear at all" and 10 "hear perfectly". The change from baseline to post-implant at 2 years is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing. | Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years | |
Primary | Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire | A scale from 0 to 10 is used, where 0 represents "can not hear at all" and 10 "hear perfectly". The change from baseline to post-implant at 3 years is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing. | Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years | |
Primary | Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire | A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from baseline to post-implant at 1 year is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life. | Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year | |
Primary | Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire | A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from baseline to post-implant at 2 years is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life. | Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years | |
Primary | Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire | A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from baseline to post-implant at 3 years is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life. | Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years | |
Secondary | Unaided Hearing Thresholds | Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 500 Hz and 4000 Hz | Baseline (i.e. pre-implant status) assessed prior to 1st switch-on | |
Secondary | Unaided Hearing Thresholds | Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 500 and 4000 Hz | post-implant at 1 year | |
Secondary | Unaided Hearing Thresholds | Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 125Hz and 8000 Hz | immediately post-implant | |
Secondary | Unaided Hearing Thresholds | Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 125Hz and 8000 Hz | post-implant at 2 years |
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