Hearing Preservation in Cochlear Implantation Surgery

Официальное название

Evaluating Cochlear Insertion Trauma and Hearing Preservation After Cochlear Implantation (CIPRES): a Study Protocol for a Randomized Single-blind Controlled Trial

Обзор

In order to preserve the residual hearing in patients with sensorineural hearing loss (SNHL) receiving a cochlear implant (CI), the insertion trauma to the delicate and microscopic structures of the cochlea needs to be minimized. The surgical procedure starts with the conventional mastoidectomy-posterior tympanotomy (MPT) approach to the middle ear, and is followed by accessing the cochlea, with either a cochleostomy (CO) or via the round window (RW). Both techniques have their benefits and disadvantages. Another aspect is the design of the electrode array. There are fundamentally two different designs: a \*straight\* lateral wall lying electrode array (LW), or a \*pre-curved\* perimodiolar cochlear lying electrode array (PM). Interestingly, until now, the best surgical approach and type of implant is unknown. 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.

Вмешательства

• Процедура Round window insertion
  Insertion of the electrode array via the round window.
• Процедура Cochleostomy insertion
  Insertion of the electrode array via cochleostomy.
• Устройство Lateral wall array
  Lateral wall electrode array from Advanced Bionics.
• Устройство Periomodiolar electrode array
  Perimodiolar MidScala electrode array from Advanced Bionics.

Первичные конечные точки

• Hearing preservation [Срок оценки: 12 months]

Вторичные конечные точки (3)

• Scalar position of the electrode array [Срок оценки: 12 months]
• Electrocochleography [Срок оценки: 12 months]
• Speech perception [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Severe hearing loss, CI candidate
• 18 years of age or older
• normal function of middle ear (i.e. no acute middle ear infections)
• dutch language proficiency
• choice for Advanced Bionics implant

Критерии исключения

• prior otologic surgery in the implanted ear (excluding tympanostomy tube placement)
• inner ear malformation present in the ear to be implanted (i.e. ossification, Mondini malformation)
• retrocochlear pathology present in the auditory system to be implanted
• neurocognitive disorders
• sudden deafness

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• University Medical Center Utrecht — Utrecht

Публикации

• Rask-Andersen H, Erixon E, Kinnefors A, Lowenheim H, Schrott-Fischer A, Liu W. Anatomy of the human cochlea--implications for cochlear implantation. Cochlear Implants Int. 2011 May;12 Suppl 1:S8-13. doi: 10.1179/146701011X13001035752174. PMID 21756464
• Escude B, James C, Deguine O, Cochard N, Eter E, Fraysse B. The size of the cochlea and predictions of insertion depth angles for cochlear implant electrodes. Audiol Neurootol. 2006;11 Suppl 1:27-33. doi: 10.1159/000095611. Epub 2006 Oct 6. PMID 17063008
• Avci E, Nauwelaers T, Hamacher V, Kral A. Three-Dimensional Force Profile During Cochlear Implantation Depends on Individual Geometry and Insertion Trauma. Ear Hear. 2017 May/Jun;38(3):e168-e179. doi: 10.1097/AUD.0000000000000394. PMID 28045786
• Snels C, IntHout J, Mylanus E, Huinck W, Dhooge I. Hearing Preservation in Cochlear Implant Surgery: A Meta-Analysis. Otol Neurotol. 2019 Feb;40(2):145-153. doi: 10.1097/MAO.0000000000002083. PMID 30624395
• Fan X, Xia M, Wang Z, Zhang H, Liu C, Wang N, Hou L, Li C, Xu A. Comparison of electrode position between round window and cochleostomy inserting approaches among young children: a cone-beam computed tomography study. Acta Otolaryngol. 2018 Sep;138(9):815-821. doi: 10.1080/00016489.2018.1478127. Epub 2018 Jun 23. PMID 29936898
• Wanna GB, Noble JH, Gifford RH, Dietrich MS, Sweeney AD, Zhang D, Dawant BM, Rivas A, Labadie RF. Impact of Intrascalar Electrode Location, Electrode Type, and Angular Insertion Depth on Residual Hearing in Cochlear Implant Patients: Preliminary Results. Otol Neurotol. 2015 Sep;36(8):1343-8. doi: 10.1097/MAO.0000000000000829. PMID 26176556
• Wanna GB, Noble JH, Carlson ML, Gifford RH, Dietrich MS, Haynes DS, Dawant BM, Labadie RF. Impact of electrode design and surgical approach on scalar location and cochlear implant outcomes. Laryngoscope. 2014 Nov;124 Suppl 6(0 6):S1-7. doi: 10.1002/lary.24728. Epub 2014 May 30. PMID 24764083
• Havenith S, Lammers MJ, Tange RA, Trabalzini F, della Volpe A, van der Heijden GJ, Grolman W. Hearing preservation surgery: cochleostomy or round window approach? A systematic review. Otol Neurotol. 2013 Jun;34(4):667-74. doi: 10.1097/MAO.0b013e318288643e. PMID 23640087

Идентификаторы

NCT: NCT07146841 · NL71233.041.19 · NL8586

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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