Sound Therapy for Tinnitus Relief in Cochlear Implant Users
Not Applicable
Terminated
- Conditions
- Tinnitus, Hearing Loss, Cochlear Implant Users
- Registration Number
- NCT03026829
- Lead Sponsor
- Cochlear
- Brief Summary
The aim of this exploratory study is to evaluate the use and effectiveness of sound therapy for tinnitus relief in cochlear implant users with tinnitus. The sound therapy is a combination of tinnitus counselling and sound enrichment with the Cochlear Active Relief from Tinnitus (CART) firmware.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
- 18 years of age or older
- Self-reported tinnitus during standard Cochlear Implant (CI) activation for at least one month
- At least three months use of unilateral or bilateral Nucleus CI(s) driven by a CP900 Sound Processor. For bilateral use the most recently activated CI is used for at least three months
- Native speaker and fluency in the language used in the assessments (i.e. Dutch)
Exclusion Criteria
- Additional handicaps that would prevent participation in evaluations
- History of psychiatric disorders or depression (on investigator's opinion)
- Unrealistic expectations as identified by the clinician on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study
- Pulsatile or diagnosed objective / middle ear tinnitus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS) week 7 Visual Analogue Scale (VAS) score on tinnitus
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI) week 7
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie tinnitus relief via CART sound therapy in cochlear implant users?
How does CART sound therapy compare to standard-of-care tinnitus treatments in cochlear implant recipients?
Are there specific auditory biomarkers that predict response to CART sound therapy in tinnitus patients with sensorineural hearing loss?
What adverse events are associated with CART firmware-based sound enrichment in cochlear implant users and how are they managed?
What combination therapies involving CART sound therapy and pharmacological agents like GABA modulators are being explored for tinnitus management?
Trial Locations
- Locations (2)
Department of Otorhinolaryngology, Maastricht University Medical Centre
🇳🇱Maastricht, Limburg, Netherlands
Department of Otorhinolaryngology, Head and Neck Surgery
🇳🇱Utrecht, Netherlands
Department of Otorhinolaryngology, Maastricht University Medical Centre🇳🇱Maastricht, Limburg, Netherlands