Perceptual Consequences of Cochlear Implant Electrode-neuron Interfaces

Deafness Clinical Trial

Official title:

Development and Assessment of Listener-tailored Programming for Cochlear Implant Listeners

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867173
• Other study ID #: MGB_2019P000239
• Status: Recruiting
• Phase: N/A
• Start date: September 16, 2022
• Est. completion date: March 31, 2027

Study information

• Verified date: March 2024
• Source: Massachusetts Eye and Ear Infirmary
• Contact: Julie Arenberg
• Phone: 617-807-7904
• Email: julie_arenberg[@]meei.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite the success of cochlear implants, devices surgically placed in the inner ears of patients with severe hearing loss, there remains substantial variability in the overall speech perception outcomes for the children and adults who receive them. The main goals of this project are: i) to improve our understanding of how cochlear implants affect the developing auditory system, ii) apply that knowledge to test new methods for programming children and adults, and iii) to study how long it takes listeners to adapt to new cochlear implant programs over the short- and long-term. The results will improve our understanding of how the deafened auditory system develops with cochlear implant stimulation and advance clinical practice to improve hearing outcomes in cochlear implant listeners.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 31, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months and older

Eligibility

Inclusion Criteria:

Research Subjects with a Cochlear Implant ADULTS Inclusion Criteria

• Adult at least 18 years old

• Native speakers of American English

• Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL

CHILDREN Inclusion Criteria

• Children at least 6 months old

• Native speakers of American English

• Wears a cochlear implant manufactured by Advanced Bionics (Clarion Hi-Focus I or newer), Cochlear, or MED-EL

• For both children and adults with a cochlear implant, some study criteria might pertain to a subset of subjects, such as a specific age at which the subjects developed a hearing loss, or was implanted.

Exclusion Criteria:

Exclusion for all Cochlear Implant Subjects:

• Inability to provide informed consent

• Does not meet the inclusion criteria for a specific study protocol, such as age of onset of hearing loss, age of cochlear implantation, duration of deafness, number of active electrodes in the cochlear implant device

• Unable to carry out the study protocol or tasks required in the study

Exclusion for all Normal Hearing Subjects:

• Inability to provide informed consent

• Hearing loss, or significant history of hearing related issues

• Unable to carry out the study protocol or tasks required in the study

Related Conditions & MeSH terms

• Deafness

Intervention

Other:
• Montreal Cognitive Assessment (MoCA)
Subjects will be asked to complete this one-page cognitive test assesses short-term memory recall and attention. This test takes approximately 10 minutes.
• Detection Threshold Testing
Subjects will be asked to listen for the softest sound they can hear ("threshold') with different electrode configurations
• Psychophysical Testing
Subjects will be asked to determine the difference between different types of sounds, such as those that vary in pitch and/or volume. Sometimes they will be asked to judge the sound quality of sounds that have very small differences, or make loudness judgments and comparisons.
• Speech Perception Testing
Subjects will be asked to listen to words and sentences in quiet and/or in the presence of background noise. For this task they will be asked to repeat the words or sentences following its presentation or use the computer mouse to respond.
• Telemetry Recordings
Subjects who wear a cochlear implant, for each cochlear implant channel or pair of channels, measurements will be made from other available electrodes in their implant.

Locations

Country	Name	City	State
United States	Mass Eye and Ear	Boston	Massachusetts
United States	Boston Children's Hospital	Waltham	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary	Boston Children's Hospital, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Slopes of the spread of excitation of the electrically evoked compound action potential responses	Responses of the auditory nerve can be measured directly from the cochlear implant using software developed by the implant manufacturer. By changing the distance between two electrodes, we can quantify the spread of activation in the cochlea.	Baseline
Primary	Slopes of a behavioral measure of spectral resolution called psychophysical tuning curves.	A behavioral test designed to measure how spectral information is processed in the auditory system. By changing the relationship between a masker and target signal, we can assess resolution.	Baseline
Primary	Changes in vowel identification scores	Medial vowel identification performance in background noise. Participants will complete age-appropriate testing.	Baseline and weekly for 10 weeks after the intervention
Primary	Changes in sentence recognition scores	Speech perception testing includes sentence recognition in noise. Participants will complete age-appropriate testing.	Baseline and weekly for 10 weeks after the intervention
Primary	Changes in speech-gap detection thresholds	Speech perception testing includes speech-gap detection. Participants will complete age-appropriate testing.	Baseline and weekly for 10 weeks after the intervention
Primary	Changes in phoneme discrimination scores	Speech perception testing includes phoneme discrimination. Participants will complete age-appropriate testing.	Baseline and weekly for 10 weeks after the intervention
Primary	Changes in time (weeks) with programming strategy	Outcome measures will be obtained at weekly intervals during the intervention, and the weekly collection of those measures will be analyzed.	Baseline and weekly for 10 weeks after the intervention
Secondary	Age	A secondary age analysis on all outcome measures will be applied.	Age at baseline
Secondary	Infant-Toddler Meaningful Auditory Integration Scale (ITMAIS) scores	The IT-MAIS is a study-team-guided parental report about how infants and toddlers are responding to sound.	Baseline, and weekly for 10 weeks after the intervention
Secondary	Macarthur-Bates vocabulary inventory scores	This test allows the study team and parents to monitor speech and language development, specifically new word learning.	Baseline, and weekly for 10 weeks after the intervention
Secondary	Hearing quality of life (HEARQL) scores	The HEAR-QL is a self-assessment test normed for children to assess how they hear in everyday life with different interventions	Baseline, 5 weeks, and 10 weeks after the intervention
Secondary	Sound quality questionnaire	Participants will be asked to rate sound quality with different interventions in comparison to their everyday listening on a 7-point scale (from minus 3 - much worse, up to plus 3 - much better, 0 is the same)	Baseline and weekly for 10 weeks after the intervention