Recruiting

Cochlear Implants

Sponsor:

NYU Langone Health

Code:

NCT07279441

Conditions

Cochlear Implant Users

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief 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 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.

Conditions

Cochlear Implant Users

Study ID

NCT07279441

Start date

Jan 2, 2025

Status verified date

Dec, 2025

Completion date

Jan 2, 2030

Anticipated

Primary completion date

Jan 2, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

460 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Cochlear Implant Users

Postlingually 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.

active comparator: Normal-Hearing Controls (Vocoder Simulation)

Normal-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.

Interventions

Experiment 1: Syntactic and Semantic Context

  • 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 Overuse

  • 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 Problem

  • 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 Comprehension

  • 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 Comprehension

  • 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 Application

  • 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

Primary outcome measure

  • Percent correct Consonant-Nucleus-Consonant (CNC) words across experiments 1-3 [ Time Frame: End experiments 1-3 (up to 9 hours) ]
  • Percent correct AzBio sentences across experiments 1-3 [ Time Frame: End experiments 1-3 (up to 9 hours) ]
  • Error rates for word identification tasks across experiments 1-3 [ Time Frame: End experiments 1-3 (up to 9 hours) ]
  • Percentage of propositions recalled from narrative passages [ Time Frame: End of experiment 4 (up to 3 hours) ]
  • Ratio of main idea recall to detail recall [ Time Frame: End of experiment 4 (up to 3 hours) ]
  • Percentage of true/false statements identified [ Time Frame: End of experiment 6 (up to 3 hours) ]
  • Percent correct increase from unstructured word lists to anomalous sentences (syntactic gain) [ Time Frame: End of experiment 1 (up to 3 hours) ]
  • Percent correct increase from anomalous sentences to meaningful sentences (semantic gain). [ Time Frame: End of experiment 1 (up to 3 hours) ]
  • Number semantically-driven misrecognitions in lure conditions [ Time Frame: End of experiment 2 (up to 3 hours) ]
  • Frequency of semantically-driven misrecognitions in lure conditions [ Time Frame: End of experiment 2 (up to 3 hours) ]
  • Difference in recall accuracy between single-sentence and two-sentence conditions [ Time Frame: End of experiment 3 (up to 3 hours) ]
  • Difference in comprehension improvement (percentage of proposition's correctly recalled) with self-paced vs. continuous presentation [ Time Frame: End of experiment 5 (up to 3 hours) ]

Central Contacts and Locations

Central contacts

Mario A. Svirsky, PhD

212-263-7217Mario.svirsky@nyulangone.org

Nicole Capach

646-501-6905Nicole.capach@nyulangone.org

Locations

Brandeis University

Recruiting

Waltham, Massachusetts, United States, 02453

Principal Investigator:

Arthur Wingfield

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Mario A. Svirsky, PhD

More Information

Sponsor

NYU Langone Health

Last update posted

Dec 12, 2025

Last verified

Dec, 2025

Keywords

  • CI
  • Cochlear implant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2025-12-12.