Clinical trial NCT03026829: Sound Therapy for Tinnitus Relief in Cochlear Implant Users
Official title: "Cochlear Active Relief From Tinnitus (CART) Sound Therapy" for Tinnitus Relief in Nucleus® Cochlear Implant Users With Tinnitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tinnitus, Hearing Loss, Cochlear Implant Users
Keywords: Sound therapy
Tinnitus relief
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2017-01-20
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
timeFrame: week 0
measure: Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
timeFrame: week 2
measure: Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
timeFrame: week 7
measure: Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
timeFrame: week 0
measure: Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
timeFrame: week 2
measure: Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
timeFrame: week 7
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Department of Otorhinolaryngology, Maastricht University Medical Centre
state: Limburg
city: Utrecht
country: Netherlands
facility: Department of Otorhinolaryngology, Head and Neck Surgery
Study officials:
affiliation: Cochlear
name: Bart Volckaerts, PhD
role: STUDY_CHAIR
References:
citation: Tyler RS, Keiner AJ, Walker K, Deshpande AK, Witt S, Killian M, Ji H, Patrick J, Dillier N, van Dijk P, Lai WK, Hansen MR, Gantz B. A Series of Case Studies of Tinnitus Suppression With Mixed Background Stimuli in a Cochlear Implant. Am J Audiol. 2015 Sep;24(3):398-410. doi: 10.1044/2015_AJA-15-0005.