Auditory Processing Disorder, Central Clinical Trial
— CISSDOfficial title:
Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study.
Verified date | July 2020 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators assume that cochlear implants in this indication are not only effective but also cost-effective. The investigators' experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation). A comparative cost-utility analysis between the two arms, of medical consequences measured in terms of quality of life will identify a preference for a strategy. Specific binaural hearing measurements with respect to each treatment option (abstention, CROS, bone conduction device, cochlear implant) will also be collected.
Status | Completed |
Enrollment | 160 |
Est. completion date | January 2019 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Social security affiliation - Single sided deafness or profound asymmetrical hearing loss confirmed using pure tone audiometry and auditory brainstem responses, with or without tinnitus - Written consent to the protocol Exclusion Criteria: - Retrocochlear pathology (vestibular schwannoma, severe central auditory processing disorder) - Major cochlear ossification or malformation - Subjects under juridical protections or tutelage measure |
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Toulouse - Pierre Paul Riquet Hospital | Toulouse | Midi-Pyrénées |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incremental cost-utility ratio | 6 months after cochlear implantation versus no treatment option | ||
Secondary | Global score of EuroQoL-5D | before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6 | ||
Secondary | Global score of Nijmegen Cochlear implant Questionnaire (NCIQ) | before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6 | ||
Secondary | Nijmegen Cochlear Implant Questionnaire (NCIQ): score in advanced auditory perception section | before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6 | ||
Secondary | Speech Reception Thresholds | Signal to noise ratio that allows 50% words recognition) in diotic hearing, dichotic hearing and reverse dichotic hearing | before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6 | |
Secondary | Mean error angle for sound localization | before and after auditory rehabilitation (cochlear implantation, CROS system or bone conduction device): Day 0, Week 3, Week 6, Month 6 |
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