Cochlear-Implant-Performance-Prediction

Despite improved technology, many cochlear implant (CI) recipients still struggle to understand speech in noise (SIN). Because the bottom-up acoustic signal generated by the implant is distorted relative to normal-hearing acoustic input, CI users rely more on top-down processing to decipher masked speech. To better predict outcomes for CI recipients, top-down auditory processing ability should be assessed. However, hearing impairment makes testing top-down auditory processing ability through auditory means difficult. The study aims to determine whether testing visual top-down processing can predict auditory top-down processing capability.

Study Overview

• Status: Enrolling by invitation
• Conditions: Performance Prediction
• Intervention / Treatment: Diagnostic test: cochlear implant user performance prediction

Detailed Description

Participants will complete a proctored, 25-minute computer-based test battery of visual cognitive tests (Stroop Test, Trail-Making Tests), visual distorted-signal tests (Scrambled Letters, VisualSNR), and auditory threshold tests (QuickSIN, Hearing Test). To prevent the accumulation of mental fatigue, tests will be administered in a predetermined order designed to minimize it. Including time for explanations for each test and questions from the participant about the testing protocol, the total time the participant will spend on the study is approximately 45 minutes.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All participants who do not fit the exclusion criteria.

Exclusion Criteria:

• Individuals who are not yet adults (infants, children, teenage children),
• Adults unable to consent,
• Adults with known impaired decision-making capacity,
• Pregnant women,
• Prisoners (or other detained/paroled individuals),
• Students or postdoctoral trainees who are taught by or academically mentored by the Principal Investigator, in compliance with the Enrollment of Students and Trainees in Research Studies policies.
• Non-fluent English speakers, Tests (specifically Scrambled Letters and QuickSIN) require proficiency in the English language.
• Individuals with severe hearing impairment, Tests (specifically QuickSIN) require participants to not have trouble hearing speech.
• Individuals with significant, uncorrected visual impairment. All visual tests require the participant to be able to read medium-sized text on a screen approximately two feet in front of them.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: performance assessment	Diagnostic test: cochlear implant user performance prediction; A battery of visual cognitive tests will be combined to identify a set of tests that can predict user performance in speech-in-noise and music perception.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SNR-loss (dB)	The Quick Sound-in-Noise (QuickSIN) test is a common method for assessing speech-in-noise perception. In this test, participants listen to sentences spoken by a female speaker in increasingly loud four-talker babble. The signal-to-noise ratio (SNR) loss for two QuickSIN tests will be averaged and recorded.	baseline
Audiogram	Behavioral hearing threshold	baseline
Stroop times	The Stroop Test assesses inhibition-concentration. This test consists of two sets of subtests. Each subtest requires reading 25 words from a table of colored words: the first subtest requires the participant to read the word, and the second requires the participant to name the color of the word. In the first set of subtests, the words will be colored corresponding to the meaning of the color word (i.e. 'Red' will be colored red). In the second set of subtests, the words will be colored in a different color than the meaning of the word (i.e.' Red' will be colored purple). The completion time of each subtest will be recorded.	baseline
Trail times	The Trail-Making Test (TMT) assesses attention and processing speed. This test consists of subtests A and B. In part A, the participant must connect dots numbered 1-25 in numerical order. In part B, the participant must connect dots numbered 1-13 and dots labeled A-L in alternating order (i.e. 1-A-2-B). If the participant makes a mistake, they must correct the mistake before moving on. The completion time of each subtest will be recorded.	baseline
Percent identified	The Scrambled Letters and VisualSNR tests were developed to assess the participant's ability to decipher garbled or distorted visual stimuli.	baseline

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cochlear implants; user performance prediction
• Other Study ID Numbers: STU00223538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No