Tinnitus and Cochlear Implants (TICIT)

University of Nottingham

Status: Invitation-only

Conditions: Tinnitus

Treatments: Device: Cochlear implant

Study type: Observational

Funder types: Other

Identifiers

NCT06085885

23004

292855 (Other Identifier)

Details and patient eligibility

About

Objectives of this study are to (1) Determine whether there are meaningful changes in tinnitus outcomes following cochlear implantation in adults with bilateral severe-to-profound hearing loss, (2) Determine the prevalence, nature, and severity of tinnitus before cochlear implantation, (3) Determine the incidence, nature, and changes in severity of tinnitus following cochlear implantation, and (4) 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.

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.

Full description

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:

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Cochlear implant recipients

Description:

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.

Treatment:

Device: Cochlear implant