Clinical trial NCT06085885: Tinnitus and Cochlear Implants
Official title: Evaluation of Factors Predicting Tinnitus Outcomes Following Cochlear Implantation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Tinnitus
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Nottingham University Hospitals NHS Trust
First posted: 2023-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe to profound hearing loss undergoing cochlear implantation.

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Tinnitus characteristics and associated medical and sociodemographic factors
timeFrame: 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
measure: Tinnitus impact
timeFrame: 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
measure: Patient health
timeFrame: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
measure: Anxiety
timeFrame: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
measure: Insomnia
timeFrame: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
measure: Life quality
timeFrame: Before cochlear implantation, two weeks after cochlear implantation, and one, three and six months after the activation of the cochlear implant
measure: Hearing function
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham Auditory Implant Programme
state: Nottinghamshire
Study officials:
affiliation: University of Nottingham
name: Derek J Hoare, PhD
role: PRINCIPAL_INVESTIGATOR
References: