Place-based Cochlear Implant Mapping

NCT05558514 | Recruiting

• 1 other identifier: 119978
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The current standard of care approach for programming cochlear implants uses a generalized pitch-map for all patients. This approach fails to account for individualized inner ear anatomy. As a result, many cochlear implant recipients experience place-pitch mismatch. We have recently developed an automated mathematical tool to produce patient-specific, customized cochlear implant pitch-maps (Helpard et al., 2021). In this study, cochlear implant recipients will be randomized to receive either the clinical default pitch-map (the control group) or a place-based pitch-map (the intervention group). Assessments will be conducted at multiple time-intervals to account for patient acclimation and plasticity to both the generalized and individualized pitch-maps. Audiological assessments will be tuned to identify patients' ability to discern pitch scaling and variation in sounds, as well as to understand complexities in speech such as mood and tone. Audiological testing will be conducted in collaboration with the National Centre for Audiology (London, ON) to ensure that the most accurate and relevant metrics are applied.

Conditions

Hearing Loss, Sensorineural; Cochlear Implants

Keywords

cochlear implant; pitch map; hearing loss; cochlear implant programming; place-pitch mismatch

Outcome Measures

Primary Outcomes (1)

• Change in score on the word and vowel recognition test (Consonant-Nucleus-Consonant (CNC) words/ phonemes)

  The CNC word test (Peterson \& Lehiste, 1962) consists of 10 lists of 50 monosyllabic (single syllable) words with equal phonemic distribution across lists. Materials will be presented in quiet at 60 decibels (dB) sound pressure level (SPL) in the sound field. Outcomes will be reported as percent correct (%).

  Baseline (pre-surgery), device activation (~ 1 month post-surgery), 1 month post-activation, 3 months post-activation, 6 months post-activation, 7 months post-activation, 1 year post-activation.

Secondary Outcomes (5)

• Change in score on the Aided Sentence (AzBio) Test

  Baseline (pre-surgery), device activation (~ 1 month post-surgery), 1 month post-activation, 3 months post-activation, 6 months post-activation, 7 months post-activation, 1 year post-activation.

• Change in score on the Speech, Spatial & Qualities of Hearing Scale (SSQ)

  Baseline (pre-surgery), 1 month post-activation, 3 months post-activation, 6 months post-activation, 7 months post-activation, 1 year post-activation.

• Change in score on self-reported sound quality

  Baseline (pre-surgery), 1 month post-activation, 3 months post-activation, 6 months post-activation, 7 months post-activation.

• Change in score on the Multi Stimulus test with Hidden Reference and Anchor (CI-MUSHRA) adapted for cochlear implants

  Baseline (pre-surgery), 1 month post-activation, 3 months post-activation, 6 months post-activation, 7 months post-activation.

• Change in score on self-reported sound localization

  Baseline (pre-surgery), 1 month post-activation, 3 months post-activation, 6 months post-activation, 7 months post-activation.

Study Arms (2)

Place-based map

EXPERIMENTAL

CIs will be mapped according to each participant's unique place-based map using MED-EL MAESTRO fitting software. Participants' audiological performance will be assessed in both the experimental and default programs at activation and at 6 months. At 1-month and 3-month visits, performance will be assessed in the participant's assigned program only. Following the 6-month testing interval, participants will listen to the alternative map than the one they were assigned for 1 additional month. At the 7-month visit, participants will be assessed in both programs. After the 7-month visit, participants will be given the choice to move forward with whichever map they prefer. The final assessment interval will take place at 1-year in the participant's chosen map.

Other: Place-based cochlear implant mapping

Default map

ACTIVE COMPARATOR

CIs will be mapped according to the clinical default program using MED-EL MAESTRO fitting software. Participants' audiological performance will be assessed in both the experimental and default programs at activation and at 6 months. At 1-month and 3-month visits, performance will be assessed in the participant's assigned program only. Following the 6-month testing interval, participants will listen to the alternative map for 1 additional month from the one they were randomly assigned. At the 7-month visit, participants will be assessed in both programs. After the 7-month visit, participants will be given the choice to move forward with whichever map they prefer. The final assessment interval will take place at 1-year in the participant's chosen map.

Other: Default cochlear implant mapping

Interventions

Place-based cochlear implant mapping OTHER

Pre-operative, 3D CT scans of the temporal bone will be uploaded into a deep learning-based tool which automatically resamples, crops, segments, analyzes, and measures the patient's specific cochlear anatomy. These measurements will be input into an individualized pitch mapping function to determine a patient-specific tonotopic distribution of frequencies (place-based map). At device activation (approximately 1 month post-surgery) CIs will be programmed according to the place-based map.

Place-based map

Default cochlear implant mapping OTHER

At device activation (approximately 1 month post-surgery) CIs will be programmed according to the clinical default program.

Default map

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 or older) with moderate-to-profound sensorineural hearing loss bilaterally or single-sided deafness (SSD)
• Approved by the Cochlear Implant Program at London Health Sciences Centre (LHSC) to undergo unilateral cochlear implantation
• Identify as a native English speaker (recorded speech recognition/perception materials are presented in English)
• Deny any cognitive issues
• Willing and able to participate in study procedures (e.g., unaided testing, speech recognition testing, spatial hearing testing)
• Willing and able to return for follow-up visits (same intervals as recommended clinically for routine follow-up)

You may not qualify if:

• Fail the Mini Mental State Examination based on their age and education level

Sponsors & Collaborators

• Western University, Canada: lead
• Academic Medical Organization of Southwestern Ontario: collaborator
• University of North Carolina: collaborator
• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: collaborator

Study Sites (1)

Western University

London, Ontario, N6A 3K7, Canada

RECRUITING

Related Publications (2)

• Helpard L, Li H, Rohani SA, Zhu N, Rask-Andersen H, Agrawal S, Ladak HM. An Approach for Individualized Cochlear Frequency Mapping Determined From 3D Synchrotron Radiation Phase-Contrast Imaging. IEEE Trans Biomed Eng. 2021 Dec;68(12):3602-3611. doi: 10.1109/TBME.2021.3080116. Epub 2021 Nov 19.

  PMID: 33983877 BACKGROUND

• Nikan S, Van Osch K, Bartling M, Allen DG, Rohani SA, Connors B, Agrawal SK, Ladak HM. PWD-3DNet: A Deep Learning-Based Fully-Automated Segmentation of Multiple Structures on Temporal Bone CT Scans. IEEE Trans Image Process. 2021;30:739-753. doi: 10.1109/TIP.2020.3038363. Epub 2020 Dec 4.

  PMID: 33226942 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sumit K Agrawal, MD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sumit K Agrawal, MD

CONTACT

519-663-3568; sumit.agrawal@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized into either the intervention group or the control group. In the intervention group, cochlear implants will be programmed according to a custom, place-based pitch map. In the control group, cochlear implants will be programmed according to the standard of care, generalized pitch map. Participants will undergo repeated audiological and music and speech perception testing at baseline, initial activation (\~ 6 months post-operative), 1-month, 3-months, 6-months, 7-months, and 1-year post-activation. Each participant will listen to their assigned map during the first 6 months of cochlear implant use. After 6 months, participants will listen to the alternative map for 1 additional month. After the 7th month, participants will have the opportunity to choose their preferred map. Final assessment will take place at 1-year post-implantation. Performance will be compared between the groups and as a function of frequency-to-place mismatch.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 28, 2022
• Study Start: June 7, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

CA (1)