Tinnitus and Cochlear Implants

Study Overview
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Brief Summary
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Primary objective: Determine whether there are meaningful changes in tinnitus outcomes following cochlear implantation in adults with bilateral severe-to-profound hearing loss. Secondary objectives: Determine the prevalence, nature, and severity of tinnitus before cochlear implantation. Determine the incidence, nature, and changes in severity of tinnitus following cochlear implantation. 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. Standard questionnaires: Completed remotely by participants using a computer or other preferred electronic device. The sample will comprise adults determined as eligible to receive a unilateral cochlear implant on the National Health Service (NHS) in the United Kingdom (UK). Inclusion criteria 18 years or older. 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 Significant difficulties preventing independent completion of study activities. 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. Online questionnaires will include standard instruments used to assess: Tinnitus and its characteristics, related socio-demographic, lifestyle and health-related factors, and access to tinnitus care as measured with the European School for Interdisciplinary Tinnitus Research Screening Questionnaire (ESiT-SQ) Tinnitus impact as measured with the Tinnitus Functional Index (TFI) Tinnitus-related psychological symptoms including anxiety as measured with the Patient Health Questionnaire (PHQ-9) mood as measured with the Generalised Anxiety Disorder Assessment (GAD-7) and insomnia as measured using the Insomnia Severity Index (ISI) Quality of life sensitive to changes in hearing as measured with the Health Utilities Index (HUI-3), and health and tinnitus as measured with the EuroQol Quality of Life Questionnaire (EQ-5D-5L) Hearing function (SSQ-12) 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 5 follow up assessments after the surgery to receive the cochlear implant, after first cochlear implant activation appointment, and at routine 1-, 3- and 6-month appointments post-activation. The baseline questionnaire 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) and/or the University of Nottingham. 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).

Official Title
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Evaluation of Factors Predicting Tinnitus Outcomes Following Cochlear Implantation

Conditions
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Tinnitus

Intervention / Treatment
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* Device: Cochlear implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older. 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: Significant difficulties preventing independent completion of study activities.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cochlear implant recipients<br>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. | Device: Cochlear implant<br>* Cochlear implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus and its characteristics, related socio-demographic, lifestyle and health-related factors, and access to tinnitus care | The European School for Interdisciplinary Tinnitus Research Screening Questionnaire (ESiT-SQ). This is a case history questionnaire without a numerical scoring system. | Before cochlear implantation, two weeks after cochlear implantation, immediately after the activation of the cochlear implant, and one, three and six months after the activation of the cochlear implant | 
| Tinnitus impact | Tinnitus Functional Index (TFI). Maximum score: 250, higher score indicates greater tinnitus symptom severity | Before cochlear implantation, two weeks after cochlear implantation, immediately after the activation of the cochlear implant, and one, three and six months after the activation of the cochlear implant | 
| Patient health | Patient Health Questionnaire (PHQ-9) scores can range from 0 to 27 with a higher score indicating more severe symptoms | Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant | 
| Anxiety | Generalised Anxiety Disorder Assessment (GAD-7) scored from 0 to 21, with a higher score indicating more severe anxiety | Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant | 
| Insomnia | Insomnia Severity Index (ISI) scored 0 to 28 with a higher score indicating more severe insomnia | Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant | 
| Quality of life | EuroQol Quality of Life Questionnaire (EQ-5D-5L) scored from 0 to 100, with a lower score indicating worse health | Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant | 
| Hearing function | Speech, Spatial and Qualities of Hearing (SSQ-12) questionnaire scored 0-120, with a higher score indicating better hearing ability | Before cochlear implantation, two weeks after cochlear implantation, immediately after the activation of the cochlear implant, and one, three and six months after the activation of the cochlear implant |