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Completed

NCT Number: NCT03958006

Simultaneous Cochlear Implantation During Translabyrinthine Resection of Vestibular Schwannoma

This study will address the feasibility of simultaneous cochlear implantation during resection of a vestibular schwannoma.

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Key information

Conditions

Vestibular Schwannoma Cochlear Implantation Cranial Nerve Diseases Cranial Nerve Neoplasms Ear Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nerve Sheath Neoplasms Nervous System Diseases Nervous System Neoplasms Neurilemmoma Neuroectodermal Tumors Neuroendocrine Tumors Neuroma Neuroma, Acoustic Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Peripheral Nervous System Neoplasms Retrocochlear Diseases Vestibulocochlear Nerve Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seilesh Babu

Farmington Hills, Michigan, 48334, United States

About this study

This is prospective study patients undergoing a translabyrinthine resection for a vestibular schwannoma with intact hearing in the contralateral ear. During surgery, simultaneous cochlear implantation will be performed if the cochlear nerve can be identified and preserved during the resection.

Relevant data to be collected will include patient demographics, details related to the vestibular schwannoma including side, size, symptoms (specifically pre-operative hearing loss, degree of tinnitus), and status of hearing in the contralateral ear. Surgical details to be recorded will include date of surgery, surgical time, and whether the cochlear nerve was identified and preserved. Details related to the post-operative course to be recorded include length of stay in the hospital, post-operative complications such as wound infection or cerebral spinal fluid (CSF) leak, and need for revision or additional procedures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a vestibular schwannoma undergoing a translabyrinthine resection with intact hearing in the contralateral ear

Exclusion criteria

-

Treatment and study plan

Cochlear Implant

Device

Tumor resection with cochlear implant

Primary outcomes

  1. Measurement of Hearing Parameters

    Time frame: 1 month, 3 months and 6 months postoperatively.

    Audiologist assesses changes in understanding of the AzBio test (words in quiet and words in background noise) post cochlear implantation.

  2. Measurement of Hearing Parameters

    Time frame: 1 month, 3 months and 6 months postoperatively.

    Audiologist assesses changes in understanding of 50 random consonant-nucleus-consonant sounds.

  3. Measurement of Hearing Parameters

    Time frame: 1 month, 3 months and 6 months postoperatively.

    Audiologist assesses changes in understanding changes in understanding of Speech, Spatial and Qualities of Hearing.

Secondary outcomes

  1. Measurement of Change of Physical Symptoms Associated with Hearing Loss

    Time frame: 1, 3 and 6 months postoperatively

    Patients will complete the Dizziness Handicap Inventory

  2. Assessment of Change of Physical Symptoms Associated with Hearing Loss

    Time frame: 1, 3 and 6 months postoperatively

    Patients will complete the Tinnitus Handicap Inventory

  3. Assessment of incision site healing

    Time frame: 1 week, and 1 and 3 months postoperatively

    Surgeon evaluates wound hearing over 3 months

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 21, 2019
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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