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Cochlear-Implant-Performance-Prediction

27. maj 2026 opdateret af: Claus-Peter Richter, MD, PhD, Northwestern University
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.

Studieoversigt

Status

Tilmelding efter invitation

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern Univeristy

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: performance assessment
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
SNR-loss (dB)
Tidsramme: baseline
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
Tidsramme: baseline
Behavioral hearing threshold
baseline
Stroop times
Tidsramme: baseline
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
Tidsramme: baseline
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
Tidsramme: baseline
The Scrambled Letters and VisualSNR tests were developed to assess the participant's ability to decipher garbled or distorted visual stimuli.
baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. juni 2025

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • STU00223538

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med cochlear implant user performance prediction

Abonner