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Cochlear Implant UsersNCT07279441

Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints

A study testing Experiment 1: Syntactic and Semantic Context, Experiment 2: False Hearing and Context Overuse and Experiment 3: Two-Sentence Problem in people with Cochlear Implant Users, run by NYU Langone Health at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study examines how cochlear implant users understand and comprehend speech in realistic communication situations. Through six experiments measuring listening effort via pupillometry and discourse comprehension, we will investigate how linguistic context, cognitive demands, and processing time affect speech… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Cochlear Implant Users
What is being tested?
Experiment 1: Syntactic and Semantic Context, Experiment 2: False Hearing and Context Overuse and Experiment 3: Two-Sentence Problem
Could I receive a placebo?
No, everyone receives an active treatment
How many people
460 participants
Where
2 sitesUnited States
Study dates
2 Jan 2025to 2 Jan 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects will be otherwise healthy normal-hearing and cochlear implant (CI) adult listeners (between 18 and 80 years old).

Who cannot join

  • Individuals below 18 years of age.
  • Individuals with evidence of neurologic, vascular or psychiatric disease or dementia, and taking medications that might interfere with task performance.
  • Individuals with a history of language disorders (besides those associated with hearing loss for the CI users). Individuals who are non-native speakers of American English.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites, 2 recruiting
  • NYU Langone Health

    New York, New York, 10016

    Mario A. Svirsky, PhD

    Recruiting
  • Brandeis University

    Waltham, Massachusetts, 02453

    Arthur Wingfield

    Recruiting

Other trials in United States

About this study

This study examines how cochlear implant users understand and comprehend speech in realistic communication situations. Through six experiments measuring listening effort via pupillometry and discourse comprehension, we will investigate how linguistic context, cognitive demands, and processing time affect speech understanding in CI users, and in normal-hearing controls) to identify factors underlying communication resilience versus vulnerability and develop improved, ecologically valid assessment and rehabilitation strategies.

Read the detailed description

This research study examines how adults using cochlear implants (CIs) understand and comprehend speech in realistic communication situations. While current clinical tests focus on how well CI users can recognize single words and simple sentences, this study investigates whether success in recognizing speech sounds actually translates to understanding the meaning and content of longer conversations and discourse.

The study will include six interconnected experiments examining: (1) how CI users use linguistic context (both adaptively and maladaptively) to understand degraded speech; (2) how listening effort affects comprehension when faced with communicative challenges like remembering multiple sentences or narratives; (3) whether giving listeners control over the speed of speech presentation improves comprehension; and (4) a clinically-applicable version of these assessments.

Throughout the experiments, researchers will measure listening effort using pupillometry (tracking pupil dilation as an index of cognitive effort) combined with behavioral measures of speech recognition and comprehension. Comprehension will be assessed using a validated framework that distinguishes between understanding main ideas versus minor details in discourse passages.

The study will include cochlear implant users and normal-hearing adults listening to degraded speech simulations via vocoders. Participants will range in age from 18 to 80 years. A comprehensive baseline battery will assess perceptual abilities (speech recognition, spectral resolution, temporal processing) and cognitive abilities (working memory, processing speed, executive function).

OBJECTIVES:

Primary objectives are to identify mechanisms underlying successful speech comprehension in CI users and to determine factors associated with resilience versus vulnerability to communicative challenges. Secondary objectives include examining relationships between cognitive abilities, listening effort, and discourse comprehension outcomes.

OUTCOMES:

This research is expected to provide more ecologically valid assessment methods for CI users, identify which individuals may benefit from specific communication strategies (such as self-paced speech), and inform development of improved rehabilitation approaches that enhance real-world communication success rather than just word recognition ability.

Being tested
Experiment 1: Syntactic and Semantic Context, Experiment 2: False Hearing and Context Overuse, Experiment 3: Two-Sentence Problem, Experiment 4: Cascading Effects on Discourse Comprehension, Experiment 5: Self-Paced Discourse Comprehension
Keywords
CI, Cochlear implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experiment 1: Syntactic and Semantic ContextBehavioural

    • Recall of meaningful sentences, anomalous word strings, and unstructured word lists
    • Measurement of syntactic and semantic gain
    • Pupillometry during auditory and visual presentation
  • Experiment 2: False Hearing and Context OveruseBehavioural

    • Two-choice word recognition task with semantic priming/luring in multi-talker babble
    • Three Signal-to-Noise Ratio (SNR) levels (heavy, medium, light noise)
    • Confidence ratings for responses
    • Pupillometry measurement
  • Experiment 3: Two-Sentence ProblemBehavioural

    • Speech recognition and recall of single sentences vs. paired sentences
    • Manipulation of inter-sentence semantic predictability (high vs. low)
    • Four test conditions: 1-sentence, 2-sentences, 2-sentences+pre-prompt, 2-sentences+post-prompt
    • Pupillometry during task
  • Experiment 4: Cascading Effects on Discourse ComprehensionBehavioural

    • Recall of 27 narrative passages (67-97 words each)
    • Propositional analysis scoring (main ideas, mid-level ideas, details)
    • Measurement of semantic hierarchy effect
    • Pupillometry during listening
  • Experiment 5: Self-Paced Discourse ComprehensionBehavioural

    • 24 discourse passages (150 words each): 12 narrative, 12 expository
    • Continuous presentation vs. self-paced presentation (stops at clause/sentence boundaries)
    • Measurement of pause times and comprehension recall
    • Pupillometry during task
  • Experiment 6: Clinical ApplicationBehavioural

    • Self-Paced Sentence Comprehension
    • Sentences with varying syntactic complexity (active-conjoined, subject-relative, object-relative)
    • Continuous vs. self-paced (with pause at major clause boundary) presentation
    • True/false comprehension verification statements
    • Pupillometry measurement
Study groups in NCT07279441
Study groupRoleWhat they receive
Cochlear Implant UsersExperimentalPostlingually deaf adults (age 18-80) with at least one year of CI experience. Participants will complete behavioral speech perception and comprehension tasks with pupillometry measurement.
Receives: Behavioral: Experiment 1: Syntactic and Semantic Context; Behavioral: Experiment 2: False Hearing and Context Overuse; Behavioral: Experiment 3: Two-Sentence Problem; Behavioral: Experiment 4: Cascading Effects on Discourse Comprehension; Behavioral: Experiment 5: Self-Paced Discourse Comprehension; Behavioral: Experiment 6: Clinical Application
Normal-Hearing Controls (Vocoder Simulation)Active comparatorNormal-hearing adults (age 18-80) listening to degraded speech via 4- and 8-channel vocoders. Participants will complete the same behavioral tasks as CI users but with (or without) acoustically degraded speech simulation.
Receives: Behavioral: Experiment 1: Syntactic and Semantic Context; Behavioral: Experiment 2: False Hearing and Context Overuse; Behavioral: Experiment 3: Two-Sentence Problem; Behavioral: Experiment 4: Cascading Effects on Discourse Comprehension; Behavioral: Experiment 5: Self-Paced Discourse Comprehension; Behavioral: Experiment 6: Clinical Application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent correct Consonant-Nucleus-Consonant (CNC) words across experiments 1-3

    Participants' ability to recognize individual spoken words will be assessed using the Consonant-Nucleus-Consonant (CNC) word test. Outcome is based on the percent of key words correctly repeated. Higher score indicate better speech understanding.

    Measured: End experiments 1-3 (up to 9 hours)

  2. Percent correct AzBio sentences across experiments 1-3

    The AzBio sentence test consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Outcome is based on the percent of AzBio sentences correctly repeated. Higher score indicate better speech understanding.

    Measured: End experiments 1-3 (up to 9 hours)

  3. Error rates for word identification tasks across experiments 1-3

    Measured: End experiments 1-3 (up to 9 hours)

  4. Percentage of propositions recalled from narrative passages

    Subjects will hear 24 150- word passages, with one half of the passages being narrative (tell a story with a setting, theme, plot, etc.) and the other half being expository (e.g. instructions from a health care provider). After each passage the subject will be asked to recall as much of the passage content as possible. Higher score indicate better speech understanding.

    Measured: End of experiment 4 (up to 3 hours)

  5. Ratio of main idea recall to detail recall

    Subjects will hear recorded narratives and will be asked to recall them as best as they can. The narratives will include main ideas (defined as propositions whose arguments are directly related to the overall meaning of the passage), mid-level propositions (those that take main propositions as their arguments), and details (propositions that take mid-level or other minor propositions as their arguments. Ratio of main idea recall to detail recall will be assessed.

    Measured: End of experiment 4 (up to 3 hours)

  6. Percentage of true/false statements identified

    Subjects will hear sentences with syntactic forms known to be graded in comprehension difficulty: active-conjoined sentences (The author insulted the critic // and the critic hired a lawyer), subject-relative sentences (The author that insulted the critic // hired a lawyer), and object-relative sentences (The author that the critic insulted // hired a lawyer). The subject will hear an equal number of each sentence type, where half are presented with self-pacing, and half are presented without interruption. After each sentence the subject will be presented that they must indicate is true or false about the sentence they just heard.

    Measured: End of experiment 6 (up to 3 hours)

  7. Percent correct increase from unstructured word lists to anomalous sentences (syntactic gain)

    Participants will hear 30 meaningful, eight-word sentences to begin. The words from this list of sentences will then be used to create the unstructured word lists and syntactic strings, such that each word would be heard equally as often across the three stimulus conditions. Therefore, each subject will hear a total of 30 meaningful sentences, 30 anomalous strings, and 30 unstructured lists, presented in a counter-balanced design. Recall accuracy for the three conditions will be compared.

    Measured: End of experiment 1 (up to 3 hours)

  8. Percent correct increase from anomalous sentences to meaningful sentences (semantic gain).

    Participants will hear 30 meaningful, eight-word sentences to begin. The words from this list of sentences will then be used to create the unstructured word lists and syntactic strings, such that each word would be heard equally as often across the three stimulus conditions. Therefore, each subject will hear a total of 30 meaningful sentences, 30 anomalous strings, and 30 unstructured lists, presented in a counter-balanced design. Recall accuracy for the three conditions will be compared.

    Measured: End of experiment 1 (up to 3 hours)

  9. Number semantically-driven misrecognitions in lure conditions

    Subjects will hear word pairs, with the second (target) word of the pair presented in multi-talker babble. There will be three conditions: Neutral prime (the first word is unrelated to the target word, e.g. Jaw-PASS), Semantic prime (the two words are semantic associates, e.g. Row - BOAT), and Semantic lure (the target word is a semantic associate of a similar word e.g. Row - GOAT, where GOAT is a lure for BOAT), thus putting the semantic context in conflict with successful perception. Number semantically-driven misrecognitions in lure conditions will be assessed.

    Measured: End of experiment 2 (up to 3 hours)

  10. Frequency of semantically-driven misrecognitions in lure conditions

    Subjects will hear word pairs, with the second (target) word of the pair presented in multi-talker babble. There will be three conditions: Neutral prime (the first word is unrelated to the target word, e.g. Jaw-PASS), Semantic prime (the two words are semantic associates, e.g. Row - BOAT), and Semantic lure (the target word is a semantic associate of a similar word e.g. Row - GOAT, where GOAT is a lure for BOAT), thus putting the semantic context in conflict with successful perception. Frequency of semantically-driven misrecognitions in lure conditions will be assessed.

    Measured: End of experiment 2 (up to 3 hours)

  11. Difference in recall accuracy between single-sentence and two-sentence conditions

    Subjects will undergo four test conditions (two will require remembering only one sentence and the other two will require remembering two sentences). For each condition there will be two combinations of semantic association between the first and second sentence (half will have high predictability, and the other half will have low predictability). Difference in recall accuracy between single-sentence and two-sentence conditions will be assessed.

    Measured: End of experiment 3 (up to 3 hours)

  12. Difference in comprehension improvement (percentage of proposition's correctly recalled) with self-paced vs. continuous presentation

    Subjects will hear 24 150- word passages, with one half of the passages being narrative (tell a story with a setting, theme, plot, etc.) and the other half being expository (e.g. instructions from a health care provider). After each passage the subject will be asked to recall as much of the passage content as possible. Subjects will be presented with equal numbers of "self-paced" passages (stopping at major clauses and sentence boundaries, subject decides when to continue) and passages presented without interruption.

    Measured: End of experiment 5 (up to 3 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start2 Jan 2025
  3. Primary completion2 Jan 2030 (estimated)
  4. Study completion2 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
460 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07279441
Sponsor's protocol ID
18-01806
Other IDs
2R01DC016834-06A1
Status last verified
Oct 2026
First submitted
9 Dec 2025
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request. Data will be made available as soon as possible or at the time of associated publications. All data to be shared will be shared by the close of the award. Data will be made available, at minimum, for seven years at a third party website (https://databrary.org/)

Questions about this trial

What is this clinical trial studying?

A study testing Experiment 1: Syntactic and Semantic Context, Experiment 2: False Hearing and Context Overuse and Experiment 3: Two-Sentence Problem in people with Cochlear Implant Users, run by NYU Langone Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mario A. Svirsky, PhD (212-263-7217, Mario.svirsky@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent correct Consonant-Nucleus-Consonant (CNC) words across experiments 1-3 (time frame: End experiments 1-3 (up to 9 hours)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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