TY - JOUR
T1 - Cochlear implantation for tinnitus in adults with bilateral hearing loss
T2 - protocol of a randomised controlled trial
AU - Assouly, Kelly
AU - Smit, Adriana L
AU - Stegeman, Inge
AU - Rhebergen, Koenraad S
AU - van Dijk, Bas
AU - Stokroos, Robert
N1 - Funding Information:
Funding Part of cost involved of this study is funded by Cochlear Ltd. as a nonrestrictive research grant (IIR1975). Cochlear Ltd. did not and will—by a research contract—not have influence on the data collection, analysis, data interpretation and publication. Competing interests KA received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant (agreement number 764604). KA and BvD are employed at Cochlear Technology Centre, Mechelen, Belgium. Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.
Publisher Copyright:
© 2021 BioMed Central Ltd.. All rights reserved.
PY - 2021/5/18
Y1 - 2021/5/18
N2 - INTRODUCTION: Tinnitus is the perception of sound without an external stimulus, often experienced as a ringing or buzzing sound. Subjective tinnitus is assumed to origin from changes in neural activity caused by reduced or lack of auditory input, for instance due to hearing loss. Since auditory deprivation is thought to be one of the causes of tinnitus, increasing the auditory input by cochlear implantation might be a possible treatment. In studies assessing cochlear implantation for patients with hearing loss, tinnitus relief was seen as a secondary outcome. Therefore, we will assess the effect of cochlear implantation in patients with primarily tinnitus complaints.METHOD AND ANALYSIS: In this randomised controlled trial starting in January 2021 at the ENT department of the UMC Utrecht (the Netherlands), patients with a primary complaint of tinnitus will be included. Fifty patients (Tinnitus Functional Index (TFI) >32, Beck's Depression Index <19, pure tone average at 0.5, 1, 2 and 4 kHz: bilateral threshold between 50 and ≤75 dB) will be randomised towards cochlear implantation or no intervention. Primary outcome of the study is tinnitus burden as measured by the TFI. Outcomes of interest are tinnitus severity, hearing performances (tinnitus pitch and loudness, speech perception), quality of life, depression and patient-related changes. Outcomes will be evaluated prior to implantation and at 3 and 6 months after the surgery. The control group will receive questionnaires at 3 and 6 months after randomisation. We expect a significant difference between the cochlear implant recipients and the control group for tinnitus burden.ETHICS AND DISSEMINATION: This research protocol was approved by the Institutional Review Board of the University Medical Center (UMC) Utrecht (NL70319.041.19, V5.0, January 2021). The trial results will be made accessible to the public in a peer-review journal.TRIAL REGISTRATION NUMBER: Trial registration number NL8693; Pre-results.
AB - INTRODUCTION: Tinnitus is the perception of sound without an external stimulus, often experienced as a ringing or buzzing sound. Subjective tinnitus is assumed to origin from changes in neural activity caused by reduced or lack of auditory input, for instance due to hearing loss. Since auditory deprivation is thought to be one of the causes of tinnitus, increasing the auditory input by cochlear implantation might be a possible treatment. In studies assessing cochlear implantation for patients with hearing loss, tinnitus relief was seen as a secondary outcome. Therefore, we will assess the effect of cochlear implantation in patients with primarily tinnitus complaints.METHOD AND ANALYSIS: In this randomised controlled trial starting in January 2021 at the ENT department of the UMC Utrecht (the Netherlands), patients with a primary complaint of tinnitus will be included. Fifty patients (Tinnitus Functional Index (TFI) >32, Beck's Depression Index <19, pure tone average at 0.5, 1, 2 and 4 kHz: bilateral threshold between 50 and ≤75 dB) will be randomised towards cochlear implantation or no intervention. Primary outcome of the study is tinnitus burden as measured by the TFI. Outcomes of interest are tinnitus severity, hearing performances (tinnitus pitch and loudness, speech perception), quality of life, depression and patient-related changes. Outcomes will be evaluated prior to implantation and at 3 and 6 months after the surgery. The control group will receive questionnaires at 3 and 6 months after randomisation. We expect a significant difference between the cochlear implant recipients and the control group for tinnitus burden.ETHICS AND DISSEMINATION: This research protocol was approved by the Institutional Review Board of the University Medical Center (UMC) Utrecht (NL70319.041.19, V5.0, January 2021). The trial results will be made accessible to the public in a peer-review journal.TRIAL REGISTRATION NUMBER: Trial registration number NL8693; Pre-results.
KW - adult otolaryngology
KW - audiology
KW - otolaryngology
UR - http://www.scopus.com/inward/record.url?scp=85106189271&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2020-043288
DO - 10.1136/bmjopen-2020-043288
M3 - Article
C2 - 34006544
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 5
M1 - e043288
ER -