Tinnitus and Cochlear Implants (TICIT)

Evaluation of Factors Predicting Tinnitus Outcomes Following Cochlear Implantation

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Tinnitus
• Intervention / Treatment: Device: Cochlear implant

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).

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• United Kingdom
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG1 5DU
      • Nottingham Auditory Implant Programme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe to profound hearing loss undergoing cochlear implantation.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Cochlear implant; Cochlear implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Tinnitus characteristics and associated medical and sociodemographic factors	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
Life quality	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

Collaborators and Investigators

• Sponsor: University of Nottingham
• Collaborators: Nottingham University Hospitals NHS Trust
• Investigators: Principal Investigator: Derek J Hoare, PhD, University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus
• Other Study ID Numbers: 23004; 292855 (Other Identifier: IRAS project ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No