NCT Number: NCT07683689
Cochlear implants are devices placed in the inner ear through surgery to help people with severe to profound hearing loss. While these devices work well overall, results vary widely from person to person. Many people with cochlear implants still have trouble understanding speech in noisy places and enjoying music.
This study looks at whether customizing the way a cochlear implant is programmed, based on the health of the hearing nerve in different areas of the ear, can help people understand speech better in noisy settings. The researchers will adjust or turn off certain electrodes in areas where the nerve appears weaker, then test whether this improves hearing compared to each person's everyday program. They will also examine whether giving people time to get used to the new program leads to better results.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Cochlear implants are surgically placed in the inner ears of people with severe to profound hearing loss. Although these devices are generally successful, outcomes differ a great deal from one person to the next. Many people who use cochlear implants continue to struggle with understanding speech when there is background noise and with appreciating music. More research is needed to understand why results vary so much among cochlear implant users.
The main goal of this study is to better understand the underlying condition of the inner ear and how it relates to how well people hear with their cochlear implant. The researchers will use this knowledge to test new ways of programming the devices. A cochlear implant has multiple electrodes, and each one stimulates a different region of the hearing nerve. In some people, certain regions of the nerve are healthier than others. By estimating where the nerve is weaker or stronger, the researchers hope to program the device in a way that takes advantage of the healthier areas.
The study has one main aim with two parts:
The first part compares how well participants understand speech in noise using their usual everyday program versus an experimental program. In the experimental program, the electrical signal is narrowed and focused for electrodes that are farther from healthy nerve regions, and electrodes near poorly functioning nerve regions may be turned off. These adjustments are guided by a model of nerve health developed in earlier research.
The second part looks at whether performance improves after participants spend four weeks getting used to the experimental program. The researchers expect that programming based on each person's individual nerve health will improve their ability to understand speech in noise, and that this improvement will be greater after they have had time to adjust to the new program.
This work is expected to provide a better understanding of how long a person needs to adapt when their programming strategy changes. The findings could be applied fairly quickly in clinical settings to improve speech understanding for both adults and children who use cochlear implants.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The participant's standard clinical cochlear implant sound-processing program, as currently fit for everyday use. This serves as the within-subjects control condition and remains available as a backup throughout the take-home trial.
An experimental cochlear implant sound-processing strategy that applies focused electrical fields for electrodes distant from regions of healthy neural tissue and/or deactivates channels near regions of poor neural density or integrity, as inferred from a previously developed electrode-neuron interface model. Tested acutely in the lab and during one 4-week take-home interval.
A second experimental cochlear implant sound-processing strategy applying focused electrical fields and/or channel deactivation based on electrode-neuron interface estimates, configured differently from Experimental Program 1. Tested acutely in the lab and during one 4-week take-home interval.
Time frame: Across a minimum of two in-lab sessions (each up to 3.5 hours)
Sentence recognition in background noise will be measured using the American Matrix Test (AMT), an adaptive, closed-set speech-in-noise test consisting of 4 blocks of 20 sentences each (5 words per sentence). The adaptive procedure yields a speech reception threshold expressed in dB SNR, the signal-to-noise ratio at which the participant correctly identifies 50 percent of words, with lower (more negative) values indicating better performance. Scores obtained with the participant's everyday clinical listening program (control) will be compared to scores obtained with two experimental sound-processing strategies that apply focused electrical fields for distant electrodes and/or deactivate channels near regions of poor neural density or integrity, as inferred from a previously developed electrode-neuron interface model.
Time frame: Across a minimum of two in-lab sessions (each up to 3.5 hours)
Medial vowel identification will be measured using a closed-set vowel discrimination task in quiet and at a +10 dB signal-to-noise ratio in four-talker babble noise. Performance is scored as percent correct, with higher values indicating better performance. Scores obtained with the participant's everyday clinical program (control) will be compared to scores obtained with the two experimental sound-processing strategies.
Time frame: Baseline and after 4 weeks of take-home use for each program, within a 12-week crossover trial
Using a randomized crossover design, sentence recognition in noise (American Matrix Test) will be assessed before and after 4 weeks of at-home listening for the control program and each experimental program. The adaptive procedure yields a speech reception threshold in dB SNR, with lower (more negative) values indicating better performance. Participants complete 4 weeks of baseline testing with their clinical program followed by 4 weeks with each of the two experimental strategies. The outcome is the change in score across time points and programs, evaluating the effect of acclimatization.
Time frame: Baseline and after 4 weeks of take-home use for each program, within a 12-week crossover trial
Using the randomized crossover design, medial vowel identification will be assessed before and after 4 weeks of at-home listening for the control and experimental programs. Performance is scored as percent correct, with higher values indicating better performance. The outcome evaluates the effect of acclimatization on performance.
Time frame: Baseline and weekly during the 12-week take-home trial
Participants rate the sound quality of the listening programs using a custom Sound Quality Questionnaire administered at baseline and at weekly intervals throughout the take-home trial. Results are reported as scores on the questionnaire's rating scale.
Time frame: Collected during in-lab sessions (each up to 3.5 hours)
The Electrically Evoked Compound Action Potential (ECAP) will be recorded via telemetry to measure the auditory nerve's response to electrical stimulation delivered through the cochlear implant. Response amplitude is reported in microvolts. This measure helps characterize the electrode-neuron interface used to inform the experimental programming strategies.
Time frame: Collected during in-lab sessions (each up to 3.5 hours)
Electrical Field Imaging (EFI) will be recorded via telemetry to measure the distribution of electrical current within the cochlea where the implant electrodes are located. Recorded voltages are reported in volts. This measure helps characterize the electrode-neuron interface used to inform the experimental programming strategies.
Time frame: Collected during in-lab sessions (each up to 3.5 hours)
Detection threshold, defined as the softest level at which the participant can detect a stimulus, will be measured across multiple electrode configurations including monopolar and novel focused stimulation modes. Thresholds are reported in clinical units (CU) as used for clinical device programming.
Time frame: Collected during in-lab sessions (each up to 3.5 hours)
Maximum comfortable level, defined as the level that is loud but still comfortable, will be measured across multiple electrode configurations including monopolar and novel focused stimulation modes. Levels are reported in clinical units (CU) as used for clinical device programming.
Contact information is provided by the study sponsor or research team.
Massachusetts Eye and Ear Infirmary
Other
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