Tinnitus Nervous System Diseases Tinnitus
Conditions
Interventions
While Part A of the study seeks to explore objective measures of tinnitus, Part B seeks to assess the effect of sound therapy on tinnitus.
In Part B, participants will be asked to com
Sponsors
Jointly sponsored by the University of Cambridge and Cambridge University NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part A: 1. Adult (aged 18+ years, with no upper limit) 2. Users of unilateral cochlear implants 3. Fluent in English 4. Attend the Emmeline Centre for Auditory Implants 5. Had their cochlear implants switched on for at least one year Part B: 1. Adult (aged 18+ years) 2. Users of unilateral cochlear implants 3. Attend the Emmeline Centre for Auditory Implants 4. Had their cochlear implants switched on for at least one year 5. Have tinnitus even when their cochlear implant is switched on 6. Scored 32 or higher in the Tinnitus Functional Index questionnaire
Exclusion criteria
Exclusion criteria: Part A and B: 1. Bilateral cochlear implantation 2. Aged less than 18 years 3. Severe visual impairment 4. Severe mental-health condition 5. Severe general-health condition 6. Currently having medication that affects tinnitus or the recording of evoked potentials Additionally, for Part B: 7. Currently receiving other treatments for tinnitus apart from tinnitus management therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: 1. Mismatch negativity: Variables are amplitude, latency, and area under the curve 2. Auditory Steady State Response and N1-P2 responses: The variable is amplitude in each case. 3. P300: The variables are amplitude and latency For all of these outcome measures (1, 2, and 3), the method of measurement is recording event-related auditory evoked potentials 4. Pupillometry: The variable is Pupillar diameter. The method of measurement is pupillometry Part B: 5. Tinnitus loudness ratings. Methods: Subjective ratings in a visual-analogue scale 6. Tinnitus annoyance ratings. Methods: Subjective ratings in a visual-analogue scale 7. One objective measure selected based on the outcomes of Part A. It could be 1, 2, 3, or 4. The measure with the highest sensitivity to separate between participants with tinnitus and without tinnitus will be used | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: 1. Variable: Tinnitus Functional Index; Method: validated questionnaire 2. Variable: Qualitative data describing each participant's tinnitus. Method: Tinnitus Cochlear Implant Questionnaire, non validated questionnaire 3. Variable: Tinnitus Loudness Ratings; Methods: Subjective ratings in a visual-analogue scale | — |
Countries
England, United Kingdom
Contacts
Public ContactMarina Salorio-Corbetto
Outcome results
None listed