An interventional study of Diagnostic tests of cochlear implant function and Diagnostic tests of auditory function in Hearing Loss, Cochlear Hearing Loss and Hearing Loss, Sensorineural, sponsored by University of Maryland, College Park. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by University of Maryland, College Park · Not applicable, Interventional, and Basic science
Among 141 studies in Hearing Loss, Sensorineural with a site in United States — 34 open to participants now, 38 under way, 1 of them phase 3. Hearing Loss, Sensorineural · United States.
Among the 141 studies in Hearing Loss, Sensorineural with a site in United States, this one is the 6th largest by planned enrollment of the 115 interventional ones that give a count, is one of 14 that started in 2022, is one of 89 with no phase, reaches primary completion later than 14 of the 37 other live ones, and was the 91st registered.
346 studies on the registry are indexed under Hearing Loss, Sensorineural; 101 are open to participants now.
Browse Hearing Loss, Sensorineural studies →34 of the 141 studies in Hearing Loss, Sensorineural with a site in United States are open now. Recruiting first, the newest first:
Skylark Bio Inc. · Sites in United States
Ages 9 mo–7 yrs
University of South Florida · Sites in United States
Ages 18–80 · Healthy volunteers
Purdue University · Sites in United States
Ages 18+
Hearts for Hearing · Sites in United States
Ages 5+ · Healthy volunteers
Cochlear · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 70 Hearing Loss, Sensorineural studies recruiting now, 39 (56%) set no upper age limit and 19 (27%) stop at 75 or younger; 26 take children under 18; 17 take healthy volunteers.
This study: 18 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
141 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 12 · Phase 3 3 · Phase 4 1
First in 1998; this study’s year is marked. 14 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 300 is above the median of 32 across 247 interventional studies indexed under Hearing Loss, Sensorineural.
Median enrollment 38 across the 115 interventional studies, 100 across the 25 observational. Of the 94 that completed or were terminated, 56 (60%) have results posted.
This tab as a report to print or save as PDF → With an account.
69 of 141 have an industry lead sponsor. The 10 most frequent:
University of Maryland, College Park is the lead sponsor of 62 studies on the registry; 15 are open to participants now.
University of Maryland, College Park has 2 studies filed under Hearing Loss, Sensorineural — fewer than ten, so there is no comparison to draw.
11 of the studies in Hearing Loss, Sensorineural with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06960616Massachusetts Eye and Ear InfirmaryImproving Clinical Efficiency by Reducing Scheduled Follow-ups Using Cochlear America's Population Mean Mapping Strategy | 2026-11-26 |
| NCT04506853Med-El CorporationSingle-Sided Deafness and Asymmetric Hearing Loss | 2026-12-21 |
| NCT04707885Ohio State UniversityClinical Utility of Residual Hearing in the Cochlear Implant Ear | 2026-12-31 |
| NCT07081542AdventHealthComparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants | 2027-01-31 |
| NCT05554692University of Maryland, College ParkPeripheral and Central Influences on Auditory Temporal Processing & Speech Perception in Older Cochlear Implantees | 2027-03 |
Add all 11 to your calendar (.ics) → With an account.
Among the 141 studies in Hearing Loss, Sensorineural with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Older adults who use cochlear implants to address hearing loss show wide variation in benefit. This research investigates the role of normal aging, the health of peripheral and central auditory pathways, and positioning of the cochlear implant electrode array in contributing to this variability. A range of input types from simple auditory signals to spoken sentences is used to examine these questions.
This research aims to understand age-related temporal processing in older cochlear-implant (CI) users. The overall objective is to disentangle the peripheral and central contributions to age-related temporal processing deficits in this population. The central hypothesis is that age-related speech perception deficits are explained by unique contributions from peripheral and central auditory functions, significantly affecting outcomes in older CI users.
The central hypothesis will be tested by determining (1) the extent to which temporal processing of simple signals from single-electrode stimulation can be explained by aging and the peripheral electrode-to-neural interface; (2) the extent to which speech perception can be explained by aging and the peripheral electrode-to-neural interface; (3) the extent and manner in which central auditory compensation overcomes peripheral processing deficits that contribute to age-related performance declines in CI subjects.
Outcome measures collected in this project include behavioral measures of speech and auditory perception and electrophysiological responses.
Also collected are questionnaire-based reports of history of CI device use, cognitive screening measures, and imaging-based information regarding electrode placement in the cochlea.
Better understanding of the locus of age-related temporal processing deficits in this population will aid in developing age-specific guidance regarding CI candidacy, programming, and rehabilitation, thereby improving expected benefit and quality of life.
346 studies on the registry are indexed under Hearing Loss, Sensorineural; 101 are open to participants now.
This study's planned enrollment of 300 is above the median of 32 across 247 interventional studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →University of Maryland, College Park is the lead sponsor of 62 studies on the registry; 15 are open to participants now.
Compared within Hearing Loss, Sensorineural, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hearing Loss. The counts are of registry records indexed under each term, refreshed daily. How we classify →
For Cochlear Implant arm:
Inclusion Criteria:
Exclusion Criteria:
For Typical Hearing arm:
Inclusion Criteria:
Exclusion Criteria:
Individuals who already use at least one cochlear implant.
Diagnostic Test: Diagnostic tests of cochlear implant function
Control group to provide baseline or comparison data
Diagnostic Test: Diagnostic tests of auditory function
Because the subjects in the study will use CI devices that they have already received as part of their standard-of-care treatment, the medical device itself is not an intervention for the purposes of this study. The intervention here will be to carry out diagnostic tests of CI function. This will include perceptual tests of temporal discrimination and speech understanding.
The intervention here will be to carry out diagnostic tests of hearing. This will include perceptual tests of temporal discrimination and speech understanding.
Perceptual forward-masking recovery
Basic measurement of temporal processing - A masker stimulus encountered before a probe/target stimulus can affect the perception of the probe stimulus to a greater/lesser degree depending on their separation in time and their absolute and relative levels. Percent correct discrimination as a function of time separation and level manipulations, as measured from a behavioral response, will be reported.
Time frame: Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Perceptual gap detection thresholds
Basic behavioral measurement of temporal processing - The ability to detect a silent gap within a stimulus typically varies depending on frequency and level characteristics of the stimulus in which the gap is embedded and also with the hearing history and age of the listener. Gap detection threshold is the shortest gap duration that can be reliably detected under a given set of conditions and is typically reported in milliseconds.
Time frame: Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Perceptual duration discrimination thresholds
Basic measurement of temporal processing - Perceptual duration discrimination thresholds summarize a listener's ability to tell apart stimuli that differ in temporal extent. Percent correct discrimination as a function of duration difference, overall stimulus duration, and level manipulations, as measured from a behavioral response, will be reported.
Time frame: Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Perceptual amplitude discrimination thresholds
Basic measurement of auditory processing - Perceptual amplitude discrimination thresholds summarize a listener's ability to tell apart stimuli that differ in level. Percent correct discrimination as a function of level difference size and average level, as measured from a behavioral response, will be reported.
Time frame: Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Speech perception
Word discrimination, consonant, vowel, and sentence perception tests. The ability to discriminate between and identify recorded words, phonemic contrasts, and sentences will be assessed behaviorally. Results are reported in terms of percent correct words or phonemes.
Time frame: Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Amplitude modulation detection performance
Measure of ability to perceive amplitude modulation using modulation depth thresholds. Amplitude modulation detection performance summarizes a listener's ability to detect the presence of slower-changing amplitude variations applied to a faster-varying carrier signal. The modulation depth of the resulting combined signal can vary between 0 to 100% of the carrier signal with larger values indicating more extreme amplitude fluctuation. This research reports on the amount of modulation that can be detected as a function of different modulator and carrier frequencies, as well as overall stimulus level, as assessed via behavioral report.
Time frame: Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Electrically evoked compound action potential (ECAP)
ECAP amplitude growth function slopes will be used to predict perceptual performance. This measure uses clinically-available software to track the growth in auditory nerve response (peak-to-peak amplitude) as input level is varied from threshold to the maximal level at which the signal is comfortably loud. The slope of input-output function will be measured for each electrode along the electrode array of each CI study participant. Steeper slopes (measured in microvolts/current unit) will be interpreted as indicating better neural health of the associated auditory neurons.
Time frame: Time Frame: Post-treatment - after at least 1 year use of a cochlear implant if CI user. Not collected from NH listeners. This measure will be collected once within a 6-month time period for each participant.
Electrically evoked compound action potential (ECAP) forward masking recovery
Electrophysiological measurement of auditory nerve refractory time. This measure will be used to predict perceptual performance. Detection thresholds will be measured as masker and probe inputs are varied among a fixed set of levels and the interval between masker and probe is adjusted in duration.
Time frame: Time Frame: Post-treatment - after at least 1 year use of a cochlear implant if CI user. Not collected from NH listeners. This measure will be collected once within a 6-month time period for each participant.
Electrically or acoustically evoked auditory brainstem response (ABR) - Wave V amplitude
Wave V from the ABR is a reflection of brainstem/midbrain processing. We will measure Wave V amplitude (microV) as the masker and probe levels and masker-to-probe interval are varied. This will be used to predict perceptual performance.
Time frame: Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Electrically or acoustically evoked auditory brainstem response (ABR) - Wave V latency
Wave V from the ABR is a reflection of brainstem/midbrain processing. We will measure Wave V latency (ms) as the masker and probe levels and masker-to-probe interval are varied. This will be used to predict perceptual performance.
Time frame: Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Cortical auditory evoked potential - N1 and P2 amplitude
Cortical (N1 and P2) amplitude (microV) in response to sound will be used to predict perceptual performance. This is an obligatory response from the auditory cortex that indicates sound detection.
Time frame: Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
Cortical auditory evoked potential - N1 and P2 latency
Cortical (N1 and P2) latency (ms) in response to sound will be used to predict perceptual performance. This is an obligatory response from the auditory cortex that indicates sound detection. There is evidence that this latency varies as a function of aging.
Time frame: Post-treatment - after at least 1 year use of a cochlear implant if CI user. No required time frame for NH comparison listeners. This measure will be collected once within a 6-month time period for each participant.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified data that document, support, and validate research findings will be made available when the main findings have been accepted for publication. De-identified data relevant to the project will be disseminated to researchers on and off-campus by request and review of the PI. After publication, research products from this project will be archived at the Digital Repository at the University of Maryland(DRUM). DRUM is a long-term, open access repository managed and maintained by the University of Maryland Libraries. Researchers and the general public can download data and code files, associated metadata and documentation, and any guidelines for reuse.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Following publication, available for at least seven years.
Access criteria: Investigators whose proposed use of the data has been approved by an independent review committee
Started Aug 2022 (actual). Primary completion is estimated for Mar 2027, 55 months after the start.
Of 82 non-industry interventional studies with no phase under Hearing Loss, Sensorineural, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 83. This study's planned 55 months is above that.
Counting every sponsor, half of 162 studies reached it within 22 months; a quarter within 6 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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University of Maryland, College Park