Sponsor study identifier
interventional
32
1 country
2
Study Start
October 3, 2017
Actual (reported)Primary Completion
January 24, 2019
Actual (reported)Study Completion
January 24, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 24, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 16, 2017
Actual (reported)January 20, 2017
Actual (reported)October 3, 2017
Actual (reported)January 24, 2019
Actual (reported)January 24, 2019
Actual (reported)Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) score on tinnitus
week 0
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) score on tinnitus
week 2
Quantification of Cochlear Implant (CI) patient's tinnitus via Visual Analogue Scale (VAS)
Visual Analogue Scale (VAS) score on tinnitus
week 7
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
week 0
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
week 2
Quantification of Cochlear Implant (CI) patient's tinnitus via Tinnitus Functional Index (TFI)
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Otorhinolaryngology, Maastricht University Medical Centre
Maastricht, Limburg, Netherlands
Department of Otorhinolaryngology, Head and Neck Surgery
Utrecht, Netherlands
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.
Bart Volckaerts, PhD
Cochlear
32 participants (actual enrollment reported by the registry).
First Submitted
January 16, 2017
First Posted
January 20, 2017
Study Start
October 3, 2017
Actual (reported)week 7
Contact the study team to confirm eligibility.
Primary Completion
January 24, 2019
Actual (reported)Study Completion
January 24, 2019
Actual (reported)Last Updated
February 15, 2019
Record last verified: 2019-02
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Source: ClinicalTrials.gov.
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