Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
50 participants
OBSERVATIONAL
2023-12-30
2024-12-31
Brief Summary
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Participants will be adults eligible to receive a unilateral cochlear implant on the National Health Service (NHS) in the United Kingdom (UK). Participants will undergo routine pre- and post-operative assessments as part of usual care, and complete online questionnaires before and after implantation to measure tinnitus and other health related factors. Mixed statistical methods will be used to characterise the sample and evaluate changes in the severity of tinnitus and patient-specific factors after implantation.
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Detailed Description
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Determine whether there are meaningful changes in tinnitus outcomes following cochlear implantation in adults with bilateral severe-to-profound hearing loss.
Secondary objectives:
1. Determine the prevalence, nature, and severity of tinnitus before cochlear implantation.
2. Determine the incidence, nature, and changes in severity of tinnitus following cochlear implantation.
3. Explore associations between tinnitus and changes in hearing, psychological health, cochlear implantation-related factors, and quality of life in cochlear implant recipients with and without tinnitus.
Patient identification:
Providers of cochlear implantation services on the National Health Service in the United Kingdom.
The schedule of questionnaires will follow the schedule of routine clinical appointments as part of the cochlear implantation care pathway including a pre-operative baseline assessment, and five follow up assessments after the surgery to receive the cochlear implant, after the first cochlear implant activation appointment, and at routine 1-, 3- and 6-month appointments post-activation. The baseline questionnaires will require about 40 min to complete and follow up questionnaires about 15-30 min.
Detailed analyses will be specified prospectively in a study analysis plan developed by the study team. Data analyses will be conducted by the study team with support from medical statisticians at the National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre (BRC). The software utilised for analyses may include Excel, SPSS, R or MATLAB. Mixed statistical methods will be used to characterise the sample and evaluate changes in the severity of tinnitus and patient-specific factors before and after implantation. Data analyses will include descriptive statistics, General/Generalised Linear Models (e.g., ANOVA, regression models) or non-parametric statistical methods where appropriate (e.g., Mann Whitney U test).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cochlear implant recipients
This study involves no clinical interventions beyond cochlear implantation that will be already available to participants as part of their routine care pathway. Participants will undergo routine pre- and post-operative assessments as part of usual care.
Cochlear implant
Cochlear implant
Interventions
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Cochlear implant
Cochlear implant
Eligibility Criteria
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Inclusion Criteria
* Determined to be eligible for unilateral cochlear implantation.
* Did not previously receive a cochlear implant in either ear.
* Sufficient written or spoken English to participate in study activities.
* Have access to internet or suitable device to complete online study questionnaires.
* Able to give informed consent.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Nottingham University Hospitals NHS Trust
OTHER
University of Nottingham
OTHER
Responsible Party
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Derek Hoare
Chief Investigator
Principal Investigators
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Derek J Hoare, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
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Nottingham Auditory Implant Programme
Nottingham, Nottinghamshire, United Kingdom
Countries
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Other Identifiers
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292855
Identifier Type: OTHER
Identifier Source: secondary_id
23004
Identifier Type: -
Identifier Source: org_study_id
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