Sound Therapy for Tinnitus Relief in Cochlear Implant Users
NCT ID: NCT03026829
Last Updated: 2019-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
32 participants
INTERVENTIONAL
2017-10-03
2019-01-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CART sound therapy
CART sound therapy
The study consists of two parts:
Phase 1: laboratory evaluation of CART sound acceptability
Phase 2: take home evaluation of CART sound therapy including baseline without CART
Interventions
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CART sound therapy
The study consists of two parts:
Phase 1: laboratory evaluation of CART sound acceptability
Phase 2: take home evaluation of CART sound therapy including baseline without CART
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Cochlear
INDUSTRY
Responsible Party
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Principal Investigators
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Bart Volckaerts, PhD
Role: STUDY_CHAIR
Cochlear
Locations
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Department of Otorhinolaryngology, Maastricht University Medical Centre
Maastricht, Limburg, Netherlands
Department of Otorhinolaryngology, Head and Neck Surgery
Utrecht, , Netherlands
Countries
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References
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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.
Other Identifiers
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CEL5684
Identifier Type: -
Identifier Source: org_study_id
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