Tinnitus and Cochlear Implants

NCT06085885 | Enrolling By Invitation DMC FDA Device

• 2 other identifiers: 23004292855
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

Study Arms (1)

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

Interventions

Cochlear implant DEVICE

Cochlear implant

Cochlear implant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe to profound hearing loss undergoing cochlear implantation.

You may qualify if:

• 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.

You may not qualify if:

• Significant difficulties preventing independent completion of study activities.

Sponsors & Collaborators

• University of Nottingham: lead
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (1)

Nottingham Auditory Implant Programme

Nottingham, Nottinghamshire, NG1 5DU, United Kingdom

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Study Officials

• Derek J Hoare, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: October 17, 2023
• Study Start: December 30, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)