Place-based Cochlear Implant Mapping
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWestern University, Canada
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Fail the Mini Mental State Examination based on their age and education level
Trial design
Design model
Crossover
Treatments tested in this trial
Place-based cochlear implant mapping
Other interventionPre-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.
Default cochlear implant mapping
Other interventionAt device activation (approximately 1 month post-surgery) CIs will be programmed according to the clinical default program.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Place-based mapExperimental treatment 1 intervention
Group B: Default mapActive comparator 1 intervention
Trial outcomes
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 (%).
Time frame
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
1
Change in score on the Aided Sentence (AzBio) Test
The AzBio sentence test (Spahr \& Dorman, 2012) consists of sentences between 3 and 12 words in length recorded from 2 female and 2 male talkers. Materials will be presented in noise at 60 decibels (dB) SPL with signal-to-noise (SNR) beginning at +10 dB SNR and increasing in difficulty by 5 decibels (dB) increments continuing until a score of 20% or less is achieved. Outcomes will be reported as percent correct (%).
Time frame
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.2
Change in score on the Speech, Spatial & Qualities of Hearing Scale (SSQ)
The SSQ (Gatehouse \& Noble, 2004) is a self-reported questionnaire designed to measure a range of hearing disabilities across several domains. Questions are divided into three sections: speech hearing, spatial hearing, and qualities of hearing. Particular attention is given to hearing speech in a variety of competing contexts, and to the directional, distance and movement components of spatial hearing. In addition, the abilities both to segregate sounds and to attend to simultaneous speech streams are assessed, reflecting the reality of hearing in the everyday world. Qualities of hearing experience include ease of listening, and the naturalness, clarity and identifiability of different speakers, different musical pieces and instruments, and different everyday sounds.
Time frame
Baseline (pre-surgery), 1 month post-activation, 3 months post-activation, 6 months post-activation, 7 months post-activation, 1 year post-activation.3
Change in score on self-reported sound quality
Sound quality of speech samples will be self-reported according to several dimensions of sound quality (overall impression, loudness, fullness, sharpness and intelligibility) on a scale from 0 (lowest quality) to 10 (highest quality) while seated at a computer. Sound quality dimensions are adapted from Gabrielsson \& Kan Sjogren, 1988.
Time frame
Baseline (pre-surgery), 1 month post-activation, 3 months post-activation, 6 months post-activation, 7 months post-activation.4
Change in score on the Multi Stimulus test with Hidden Reference and Anchor (CI-MUSHRA) adapted for cochlear implants
The CI-MUSHRA) adapted for cochlear implants (Roy et al., 2012) is a self-reported measure of sound quality in which participants listen to a set of recorded music samples and rate the sound quality on a sliding scale from "0" (very poor) to "100" (excellent). Samples are presented in an unaltered version (i.e., "reference") and in a highly degraded version (i.e., "anchor"). Participants are asked to rate sound quality differences among each anchor and labeled reference. Music samples will include: (a) 3 genres (classical, jazz, and pop/rock) with 5 stimuli per genre; and (b) high pass filtering at 100 Hz, 200 Hz, 400 Hz, 600 Hz, and 800 Hz frequencies. The anchor will be a bandpass version of the original with 1000 Hz - 1200 Hz passband.
Time frame
Baseline (pre-surgery), 1 month post-activation, 3 months post-activation, 6 months post-activation, 7 months post-activation.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Western University, Canada
Lead sponsor
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
Source ClinicalTrials.gov