Trial of Image-Guided Cochlear Implant Programming Versus Standard of Care

NCT02815124 | Withdrawn

• 2 other identifiers: 160461R01DC014462
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. While remarkably successful, even in the best of performers restoration of hearing to levels of normal listeners is unusual. Approximately 3 weeks after surgery, cochlear implants are activated via mapping - a process in which each individual electrode (FDA approved cochlear implants have between 12 and 22 electrodes) is turned on and the stimulus level adjusted to a level that is comfortable and beneficial to the recipient. At present, this standard of care mapping procedure is performed without knowledge of the physical location between the cochlear implant electrodes and the neural interface. Our team has developed a new method of mapping using post-operative CT scans and image processing to specify the physical relationship between the cochlear implant electrodes and the neural interface allowing customized mapping. Using this information, the investigators deactivate sub-optimally positioned electrodes. The investigators term this "Image-guided Cochlear Implant Programming" (IGCIP). In a prospective fashion, the investigators have implemented IGCIP on cochlear implant recipients who have had at least 6 months of standard of care (SOC) mapping. The purpose of this study is to perform a randomized controlled trial (RCT) on newly activated cochlear implant recipients randomizing between IGCIP and SOC.

Conditions

Cochlear Implant

Outcome Measures

Primary Outcomes (3)

• AzBio Sentence Scores at +5 Signal to Noise Ratio (SNR)

  Month 1 post cochlear implant activation

• AzBio Sentence Scores at +5 Signal to Noise Ratio (SNR)

  Month 3 post cochlear implant activation

• AzBio Sentence Scores at +5 Signal to Noise Ratio (SNR)

  Month 6 post cochlear implant activation

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Cochlear Implant programming using standard of care

Other: Standard of Care

Image-Guided Cochlear Implant Programming

EXPERIMENTAL

Cochlear Implant programming using Image-Guided Cochlear Implant Programming

Other: Image-Guided Cochlear Implant Programming

Interventions

Standard of Care OTHER

Post Cochlear Implant surgery, subject will receive activation/programming of their implant using Standard of Care

Standard of Care

Image-Guided Cochlear Implant Programming OTHER

Post Cochlear Implant surgery, subject will receive activation/programming of their implant using Image-Guided Cochlear Implant Programming

Image-Guided Cochlear Implant Programming

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years of age that have undergone diagnostic testing for sensorineural hearing loss and are candidates for cochlear implantation will be considered eligible for the study

You may not qualify if:

• Age \< 18 years
• Pre-lingual onset of deafness
• Mini-Mental State Exam \< 24 (to remove cognitive decline as a confounding variable)
• Congenital inner ear malformation as detected on pre-operative CT scan performed as routine care
• Non-English speaking (because our audiological speech testing battery is validated for English speakers)
• Have undergone cochlear implantation outside of the Vanderbilt system
• Pregnancy which is a contraindication for elective CT scanning and surgery

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Robert F. Labadie, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Benoit M. Dawant, PhD

  Vanderbilt University Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair, Chief Research Officer, Professor of Otolaryngology-Head and Neck Surgery, Professor of Biomedical Engineering

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 28, 2016
• Study Start: December 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 31, 2021
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)