Tinnitus Suppression for Cochlear Implant Recipients

NCT02794623 | Completed

• 1 other identifier: CRC 5583
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Tinnitus is the perception of sound in the absence of an external sound. Prevalence in the general population is 10 to 15%, with tinnitus severely impacting quality of life in 1-2 percent of the population. Tinnitus therapy is based on counselling, cognitive and behavioural therapies in combination with sound therapies which mostly rely on masking. For cochlear implant candidates, the ability to use hearing aids and maskers is limited by the degree of their hearing loss. Reports of tinnitus prevalence in this group range from 67 to 100% with a mean of 80%. In cochlear implant (CI) recipients, tinnitus suppression primarily occurs during active use of the cochlear implant system. In some CI recipients residual inhibition of tinnitus occurs when the implant is switched off. While the benefits of CI implantation on tinnitus are well documented, there is a group of recipients where tinnitus remains a concern in the implanted ear post-operatively. The primary aim of this study is to investigate the benefits of using tinnitus masking via a CI sound processor that optimises tinnitus suppression with minimal annoyance to the user. Furthermore a questionnaire will be employed to capture the prevalence, degree and nature of tinnitus in recipients.

Conditions

Tinnitus

Keywords

cochlear implants; hearing loss

Outcome Measures

Primary Outcomes (3)

• Tinnitus Severity Questionnaire

  Tinnitus severity questionnaire using Visual Analog Scale

  Testing over 6 months

• Word recognition scores in quiet

  Monosyllabic word scores in quiet

  Testing over 6 months

• Speech recognition scores in noise

  Sentence recognition scores in noise

  Testing over 6 months

Secondary Outcomes (1)

• Degree of handicap as a result of tinnitus

  Testing over 6 months

Study Arms (1)

Cochlear Implant Recipients

EXPERIMENTAL

Device: Tinnitus masking

Interventions

Tinnitus masking DEVICE

Tinnitus masking via CI system

Cochlear Implant Recipients

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Freedom or CI500 series implant
• At least 3 months experience with the cochlear implant
• Native speaker in the language used to assess speech perception performance
• Willingness to participate in and to comply with all requirements of the protocol
• Self-reported tinnitus in the implanted ear
• Reside local to investigational site

You may not qualify if:

• Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and test including MRI
• Additional handicaps that would prevent participations in evaluations
• Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study

Sponsors & Collaborators

• The Hearing Cooperative Research Centre: lead
• Royal Victoria Eye and Ear Hospital: collaborator
• Cochlear: collaborator

Study Sites (1)

The HEARing CRC

Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Tinnitus; Hearing Loss

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 9, 2016
• Study Start: October 18, 2014
• Primary Completion: March 1, 2018
• Study Completion: June 8, 2018
• Last Updated: July 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)