scholarly journals Evaluating cochlear insertion trauma and hearing preservation after cochlear implantation (CIPRES): A study protocol for a randomised single blind controlled trial

2020 ◽  
Author(s):  
Saad Jwair ◽  
Ralf Boerboom ◽  
Huib Versnel ◽  
Robert Stokroos ◽  
Hans Thomeer
Keyword(s):  
Randomized Controlled Trial ◽  
Hearing Loss ◽  
Surgical Approach ◽  
Controlled Trial ◽  
Round Window ◽  
Electrode Array ◽  
Hearing Preservation ◽  
Residual Hearing ◽  
Structure Preservation ◽  
Randomized Controlled

Abstract BackgroundIn order to preserve residual hearing in patients with sensorineural hearing loss (SNHL) who receive a cochlear implant (CI), insertion trauma to the delicate structures of the cochlea needs to be minimized. The surgical approach comprises the conventional mastoidectomy-posterior tympanotomy (MPT) to arrive at the middle ear, followed by either a cochleostomy (CO) or the round window (RW) approach. Both techniques have their benefits and disadvantages. Another important aspect in structure preservation is the design of the electrode array. Two different designs are used: a ‘straight’ lateral wall lying electrode array (LW), or a ‘pre-curved’ perimodiolar lying electrode array (PM). Interestingly, until now, the best surgical approach and design of the implant is uncertain. Our hypothesis is that the combination of a RW approach and a LW lying electrode array minimizes insertion trauma, leading to better hearing outcome for SNHL patients. MethodsWe designed a monocenter, 2x2, randomized controlled trial to compare insertion trauma between four groups of patients, with each group having a unique combination of electrode array type (LW or PM) and surgical approach (RW or CO). In total, 48 patients will be randomized into one of these four intervention groups. Our primary objective is comparison of postoperative hearing preservation between these four groups. Secondly, we aim to assess structure preservation (i.e., scalar transposition, with basilar membrane disruption or tip fold-over of array) for each group. Thirdly, we will compare objective outcomes of hearing and structure preservation by way of electrocochleography (ECochG).DiscussionCochlear implantation by way of a cochleostomy or round window approach, using different electrode array types, is the standard medical care for patients with severe to profound bilateral sensorineural hearing loss, as it is a relative simple and low-risk procedure that greatly benefits patients. However, loss of residual hearing remains a problem. This trial is the first randomized controlled trial that evaluates the effect of cochlear insertion trauma of several CI treatment options on hearing preservation. Trial registrationThis trial is registered in the Netherlands Trial Register (NTR) (www.trialregister.nl): NL8586, date of registration: 4th of May 2020. Retrospectively registered; 3/48 participants were included before registration.

scholarly journals Evaluating cochlear insertion trauma and hearing preservation after cochlear implantation (CIPRES): a study protocol for a randomized single-blind controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Saad Jwair ◽  
Ralf A. Boerboom ◽  
Huib Versnel ◽  
Robert J. Stokroos ◽  
Hans G. X. M. Thomeer
Keyword(s):  
Randomized Controlled Trial ◽  
Surgical Approach ◽  
Controlled Trial ◽  
Treatment Options ◽  
Round Window ◽  
Electrode Array ◽  
Hearing Preservation ◽  
Residual Hearing ◽  
Structure Preservation ◽  
Randomized Controlled

Abstract Background In order to preserve residual hearing in patients with sensorineural hearing loss (SNHL) who receive a cochlear implant (CI), insertion trauma to the delicate structures of the cochlea needs to be minimized. The surgical approach comprises the conventional mastoidectomy-posterior tympanotomy (MPT) to arrive at the middle ear, followed by either a cochleostomy (CO) or the round window (RW) approach. Both techniques have their benefits and disadvantages. Another important aspect in structure preservation is the design of the electrode array. Two different designs are used: a “straight” lateral wall lying electrode array (LW) or a “pre-curved” perimodiolar lying electrode array (PM). Interestingly, until now, the best surgical approach and design of the implant is uncertain. Our hypothesis is that there is a difference in hearing preservation outcomes between the four possible treatment options. Methods We designed a monocenter, multi-arm, randomized controlled trial to compare insertion trauma between four groups of patients, with each group having a unique combination of an electrode array type (LW or PM) and surgical approach (RW or CO). In total, 48 patients will be randomized into one of these four intervention groups. Our primary objective is the comparison of postoperative hearing preservation between these four groups. Secondly, we aim to assess structure preservation (i.e., scalar translocation, with basilar membrane disruption or tip fold-over of array) for each group. Thirdly, we will compare objective outcomes of hearing and structure preservation by way of electrocochleography (ECochG). Discussion Cochlear implantation by way of a cochleostomy or round window approach, using different electrode array types, is the standard medical care for patients with severe to profound bilateral sensorineural hearing loss, as it is a relatively simple and low-risk procedure that greatly benefits patients. However, loss of residual hearing remains a problem. This trial is the first randomized controlled trial that evaluates the effect of cochlear insertion trauma of several CI treatment options on hearing preservation. Trial registration Netherlands Trial Register (NTR) NL8586. Registered on 4 May 2020. Retrospectively registered; 3/48 participants were included before registration.

scholarly journals A maradványhallás megőrzésének lehetőségei cochlearis implantáció során Nucleus CI532 Slim Modiolar elektródasorral

2018 ◽  
Vol 159 (41) ◽  
pp. 1680-1688 ◽  
Author(s):  
Roland Nagy ◽  
János András Jarabin ◽  
Balázs Dimák ◽  
Ádám Perényi ◽  
Ferenc Tóth ◽  
...  
Keyword(s):  
Hearing Loss ◽  
Minimally Invasive ◽  
Cochlear Implantation ◽  
Basilar Membrane ◽  
Round Window ◽  
Spiral Ganglion ◽  
Hearing Threshold ◽  
Electrode Array ◽  
Hearing Preservation ◽  
Residual Hearing

Abstract: During the rehabilitation of hearing-impaired patients, the preservation of residual acoustic hearing following cochlear implantation by minimizing the implantation trauma allows for improved hearing performance. To achieve this, minimally invasive, soft surgery methods and thinner, atraumatic electrodes were required. In our present study, we reported a case where Cochlear® Nucleus CI532 Slim Modiolar electrode was implanted in a patient with residual hearing. Our aim was to study the possible preservation of postoperative acoustic residual hearing by audiological monitoring. Since childhood, due to her congenital hearing loss, she has been wearing a conventional, airborne hearing correction device on both ears. Six months before cochlear implantation, we measured the progression on both sides of the hearing loss, so we decided to perform cochlear implantation. The patient had residual hearing on both ears prior to surgery thus the Cochlear® Nucleus CI532 Slim Modiolar Implant was used. The minimally invasive surgery was performed on the patient’s right ear through the round window approach. Compared to the preoperative hearing threshold (average 85 dBHL) in the 4th postoperative week, an initial hearing threshold progression of 20–25 dBHL was observed between 0.25 and 1.0 kHz, while of 5–10 dBHL between 2.0–4.0 kHz. Hearing threshold measured in the 6th month showed a slight progression in the range above 1 kHz, but improved by the 12th month, to the results achieved at the 4th week. The effects of cochlear implantation on residual hearing have been studied in numerous studies, in which several key surgical and technical factors have been identified. Nucleus CI532 is a Slim Modiolar electrode profile that is close to the modiolus, so it is expected to have a lower endocochlear hydrodynamic load since it lies in the covering of the osseus spiral lamina, thus less influencing the dynamics of the basilar membrane. However, the perimodiolar location of the electrode array allows the adjacent nerve elements of the spiral ganglion to be stimulated with a lower electrical intensity and a reduced surface that may be neuroprotective. Preservation of acoustic residual hearing following cochlear implantation improves the patient’s speech perception and the sound localization skills, particularly in difficult circumstances. Long-term residual hearing preservation may also be of great importance in the subsequent feasibility for regenerative procedures and drug treatments. Orv Hetil. 2018; 159(41): 1680–1688.

scholarly journals Vestibular prognosis in idiopathic sudden sensorineural hearing loss with vestibular dysfunction treated with oral or intratympanic glucocorticoids: a protocol for randomized controlled trial

2020 ◽  
Author(s):  
Huawei Li ◽  
Weiming Hao ◽  
Liping Zhao ◽  
Huiqian Yu
Keyword(s):  
Randomized Controlled Trial ◽  
Hearing Loss ◽  
Sensorineural Hearing Loss ◽  
Controlled Trial ◽  
Vestibular Function ◽  
Vestibular Dysfunction ◽  
Sudden Sensorineural Hearing Loss ◽  
Sensorineural Hearing ◽  
Hearing Outcome ◽  
Randomized Controlled

Abstract Background Idiopathic sudden sensorineural hearing loss (ISSNHL) is a rapid-onset sensorineural hearing impairment with unclear etiology and unsatisfying treatment effects. Vestibular dysfunction has been considered as a poor indicator in the clinical manifestations and prognosis of ISSNHL, which occurred in approximately 28%-57% cases. Glucocorticoids, administered through oral or intratympanic way, is currently a regular and standard treatment for ISSNHL based on hearing outcome. However, little investigations have been conducted on the recovery process and treatment effects of glucocorticoids on vestibular dysfunctions of ISSNHL. This study aims to compare the efficacy of oral or intratympanic glucocorticoids in ISSNHL with vestibular dysfunction in terms of the pattern and trajectory of possible process of vestibular function recovery.Methods/Design A randomized, outcome-assessor- and analyst-blinded, controlled, clinical trial (RCT) will be carried out. A group of seventy-two patients with ISSNHL complaining of vestibular dysfunction appearing as vertigo, dizziness or imbalance will be recruited and randomized into two arms of either oral or intratympanic glucocorticoids therapy with a 1:1 allocation ratio. The primary outcomes will be vestibular function outcomes assessed by sensory organization test, caloric test, video head impulse test, and vestibular evoked myogenic potentials; the secondary outcomes include self-reported vestibular dysfunction symptoms; dizziness-related handicap, visual analogue scale for vertigo and tinnitus; and pure tone audiometry. Assessment will be performed at baseline and at 1, 2, 4, and 8 weeks post-randomization. To our knowledge, this will be the first randomized controlled trial focusing on the prognosis of vestibular dysfunction in ISSNHL and the efficacy of glucocorticoids therapy for the vestibular dysfunction in this disease.Discussion This trial will be the first RCT study focusing on the progress and prognosis of vestibular dysfunction in ISSNHL. Efficacy of two commonly used therapies of glucocorticoids will be compared in both auditory and vestibular function fields, rather than in the hearing outcome alone. Trial registration ClinicalTrials.gov, NCT03974867. Registered on July 23, 2019.

Randomized controlled trial to test the efficacy of trans-tympanic injections of a sodium thiosulfate gel to prevent cisplatin-induced ototoxicity.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e17560-e17560
Author(s):  
Francois Meyer ◽  
Viannique Rolland ◽  
Isabelle Bairati ◽  
Matthieu Guitton ◽  
André Fortin ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Hearing Loss ◽  
Adverse Effects ◽  
Middle Ear ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Locally Advanced ◽  
Sodium Thiosulfate ◽  
Hearing Threshold ◽  
Randomized Controlled

e17560 Background: The hearing loss due to cisplatin cochlear damage is frequent and severe. Antioxidants, such as sodium thiosulfate (STS), can neutralize the effects of cisplatin, but, when administered systemically, they decrease its efficacy. In animal experiments, STS deposited in the middle ear reached the cochlea and reduced cisplatin ototoxicity. We conducted a randomized controlled trial to test the efficacy of trans-tympanic injections of a STS gel to prevent cisplatin-induced ototoxicity. Methods: Eligible participants were patients with symmetrical hearing treated for a locally advanced head and neck cancer with chemoradiation including 3 cisplatin cycles (100 mg/m2). For each participant, one randomly selected ear received the injections while the other ear did not. On the eve of each cisplatin treatment, a trans-tympanic injection deposited 0.1 ml of an immediately prepared STS-hyaluronate gel (0.5 M) on the round window. The main outcome was assessed blindly using the shift of hearing threshold in decibels (dB) from before chemoradiation to one month thereafter for pure-tone air conduction at 0.5-14 kHz frequencies. Adverse effects were noted according to CTCAE. Assuming a lower hearing loss of 7.0 dB for the treated ears, 0.90 power and 0.05 two-sided statistical significance, 25 patients were needed. The main outcome was assessed in a mixed linear model with hearing threshold shift as dependent variable and intervention, frequency and radiation dose to the cochlea as independent variables. Results: From January to December 2015, 13 patients were randomized. The trial was stopped in June 2016 for poor accrual. The average loss of hearing over all frequencies was 1.5 dB less for the treated ears than for the control ears. The difference was not statistically (p = 0.56) nor clinically significant, but was consistently in favor of the treated ears for all frequencies between 3 and 10 kHz. The intervention adverse effects were mild. Conclusions: Our trial suggests that STS deposited in the middle ear reached the cochlea but was not clinically effective. More work is needed to improve the efficacy of trans-tympanic administration of cisplatin antidotes. Clinical trial information: NTC02281006.

Welche Behandlung wirkt beim Hörsturz am besten?

2018 ◽  
Vol 97 (07) ◽  
pp. 448-449
Author(s):  
Volker Schartinger
Keyword(s):  
Randomized Controlled Trial ◽  
Hearing Loss ◽  
Combination Therapy ◽  
Sensorineural Hearing Loss ◽  
Systemic Therapy ◽  
Controlled Trial ◽  
Sudden Sensorineural Hearing Loss ◽  
Sensorineural Hearing ◽  
Randomized Controlled

Ashtiani MK at al. Efficacy of systemic and intratympanic corticosteroid combination therapy versus intratympanic or systemic therapy in patients with idiopathic sudden sensorineural hearing loss: a randomized controlled trial. Eur Arch Otorhinolaryngol 2018; 275: 89–7 Iranische HNO-Ärzte verglichen die Heilungsraten einer Behandlung des idiopathischen Hörsturzes mit oralen und intratympanalen Kortikosteroidgaben in Mono- und Kombinationstherapien.

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