CI Following VS Removal or Labyrinthectomy

Status Recruiting

Clinical Trial Summary

This study is a prospective, clinical study to determine if it is safe and effective to use a cochlear implant over time in individuals undergoing removal of a vestibular schwannoma (VS), benign tumor of the hearing and balance nerve or undergoing a labyrinthectomy for treatment of Meniere's disease. Individuals undergoing these surgeries will be deaf on the surgical side after the procedure. Currently, cochlear implants are approved for use and not considered investigational in individuals with hearing loss on both sides. However, use of a cochlear implant for these patient populations (single-sided hearing loss) will be considered a new use of an approved device. Participants undergoing surgery to remove a VS or having a labyrinthectomy will have a cochlear implant inserted after the surgical procedure for clinical care. Approximately 4 weeks after surgery, participants will be fitted with an external speech processor on the surgical side that will stimulate the internal cochlear implant. Participants will return at the following intervals after the initial processor fitting: 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months. At each interval, participants will complete questionnaires on how they are hearing with the implant and their quality of life with the implant and be tested on their ability to hear sounds and understand speech. Potential risks are those associated with all cochlear implant surgeries, and include device failure resulting in removal of device, irritation or redness in surgical area and/or area where processor is attached, increased ringing in the ear, facial nerve stimulation and a change in the way speech and other sounds sound through the implant. Potential benefits to individual participants in this study include improvement in detection and speech understanding of the surgical ear. Participants may also experience improved abilities to locate sound and understand speech in noise as the result of having hearing on both sides.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03795675
Study type	Interventional
Source	Ohio State University
Contact	Meghan Hiss, AuD
Phone	614-366-1549
Email	Meghan.Hiss@osumc.edu
Status	Recruiting
Phase	N/A
Start date	January 14, 2019
Completion date	December 2025

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT04196933` - Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma	N/A
Active, not recruiting	`NCT00973739` - Lapatinib Study for Children and Adults With Neurofibromatosis Type 2 (NF2) and NF2-Related Tumors	Phase 2
Completed	`NCT04351373` - Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560	Phase 2
Active, not recruiting	`NCT01449604` - Stereotactic Radiation in Vestibular Schwannoma	Phase 3
Completed	`NCT01207687` - Bevacizumab for Symptomatic Vestibular Schwannoma in Neurofibromatosis Type 2 (NF2)	Phase 2
Not yet recruiting	`NCT05567341` - Remote Ischemic Preconditioning in Vestibular Schwannoma Surgery	N/A
Completed	`NCT02249572` - Vestibular Schwannoma - Radiosurgery or Expectation: V-REX.	N/A
Terminated	`NCT05116878` - Enhancing Facial Nerve Function With Omega-3 After Resection of Vestibular Schwannoma	N/A
Active, not recruiting	`NCT03095248` - Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors	Phase 2
Recruiting	`NCT04801953` - Nimodipine in Vestibular Schwanommas	Phase 2
Recruiting	`NCT03745560` - Intraoperative EABR for Decision Making
Recruiting	`NCT04859335` - Evolution of Balance and Vestibular Function in Patients Treated With Gammaknife Radiosurgery for Vestibular Schwannoma	N/A
Recruiting	`NCT04128345` - Novel Multimodality Imaging for Navigation in Skull Base Surgery
Active, not recruiting	`NCT01199978` - Hearing Outcomes Using Fractionated Proton Radiation Therapy for Vestibular Schwannoma	Phase 2
Recruiting	`NCT04057976` - Use of DTT to Define Facial Nerve Position in Vestibular Schwannomas	N/A
Completed	`NCT00863122` - Concentration and Activity of Lapatinib in Vestibular Schwannomas	Early Phase 1
Recruiting	`NCT04374305` - Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)	Phase 2
Recruiting	`NCT03079999` - Study of Aspirin in Patients With Vestibular Schwannoma	Phase 2
Recruiting	`NCT05786144` - Vestibular Schwannoma Organoids
Recruiting	`NCT03593577` - Secondary Endolymphatic Hydrops and Vestibular Schwannomas on 3 Tesla MRI

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.