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Patient-Oriented Research to Optimize Cochlear Implant Outcomes

24. juni 2026 opdateret af: Aaron Moberly, Vanderbilt University Medical Center

The rationale is that only through understanding how individual Cochlear Implant (CI) patients respond to interventions investigators further develop precision-medicine approaches to optimize outcomes. In the proposed research study to investigate the hypotheses, investigators will address two Specific Aims:

Specific Aim #1: Define the auditory (bottom-up), cognitive-linguistic (top-down), and functional neuroimaging profiles of adult CI users. Investigators will enroll experienced CI users (> 6 months of CI use).

Specific Aim #2: Determine the feasibility of "auditory" (bottom-up) and "cognitive" (top-down) interventions to improve speech processing in adult CI users.

The main hypothesis is that the two interventions are feasible. Investigators also hypothesize that our study protocol will detect the variance in auditory processing profiles and that investigators will show promise in improving both speech processing (using speech recognition and Functional Near-Infrared Spectroscopy (fNIRS) responses)) and real-world functioning (using patient-reported measures), compared with no intervention.

Additional hypotheses to be explored are that baseline profile (as defined in Aim #1) will impact the magnitude of participants' responses to the interventions, as will order of interventions (Auditory-Cognitive vs. Cognitive-Auditory, AC vs CA).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Specific Aim 1: Along with collection of demographic/audiologic and datalogging variables, participants will be tested for auditory spectro-temporal resolution and cognitive-linguistic functions. Functional near-infrared spectroscopy (fNIRS) will be collected, reflecting cortical responses to speech.

Using cluster analyses, investigators will test the hypothesis that different profiles exist, with different CI users demonstrating different patterns of bottom-up processing, top-down processing, or both. Patient-reported outcomes of CI-related quality of life, communication, and satisfaction will also be assessed to relate speech recognition to broader real world functioning.

Specific Aim 2: The "auditory" intervention includes a two-pronged approach of, first, verifying fitting via upper stimulation levels shaped to electrically evoked stapedial reflex thresholds (eSRTs) and lower stimulation levels fit to CI-aided detection between 20 and 30 dB Hearing Loss (HL), and second, image-guided cochlear implant programming (IGCIP) to reduce CI channel interaction. The "cognitive" intervention consists of computerized auditory-cognitive training using a well-established home-based training program focused on improving speech recognition through engaging cognitive processes known to be integral for successful listening in challenging conditions.

CI users from Aim #1 will be randomized to one of three groups:

  1. Group 1 receives an auditory intervention followed by a cognitive intervention (AC group);
  2. Group 2 receives a cognitive intervention followed by an auditory intervention (CA group); or (3) Group 3 is a passive control group that does not receive an intervention (Control group).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University Medical Center
        • Kontakt:
        • Ledende efterforsker:
          • Aaron Moberly, MD

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Adults between ages of 18 years and 95 years
  2. Native language is American English
  3. Have one or two CIs from any of the three FDA-approved CI manufacturers (Cochlear Americas, Advanced Bionics, MED-EL).
  4. Experience of >6 of CI use.

Exclusion Criteria:

  1. Score 24 or below on a visual Mini-Mental State Exam (MMSE; Folstein et al., 1975) to rule out dementia
  2. Known diagnosis of dementia
  3. Under the age of 18 years
  4. Unable to read and write in English (WRAT score <70)
  5. Poorer than 20/40 near vision on near-vision screening.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Group 1 - Auditory Intervention (AC)
Those randomized to Group 1 will receive auditory training for 4 weeks prior to the crossover to the cognitive training.
Adfærdsmæssigt: AC Group

Following completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcomes.

The auditory intervention consists of two in person visits:

Visit 1: Measurement of electrically evoked stapedius reflex thresholds (eSRTs), which do not require active participant responses CI-aided detection testing using the participant's everyday map in a sound field Assessment of threshold and comfort levels. Audio will be recorded for responses for later analysis.

Visit 2: Image-Guided Cochlear Implant Programming (IGCIP). CT-guided programming to deactivate channels with potential cross-stimulation conducted by a trained audiologist as part of routine clinical practice. The patient will also undergo speed recognition testing.

At the midpoint visit, the AC Group will crossover to the CA Group Study Procedures.

Adfærdsmæssigt: CA group

Following completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcome measures.

Cognitive Intervention Procedures The cognitive intervention will be conducted remotely over 4 weeks, consisting of: Approximately 1 hour per day, 5 days per week, 20 sessions total.

Participants will complete training using a laptop or smartphone. Participants may receive in-person or remote training prior to intervention initiation.

At the midpoint visit, the CA Group will crossover to the AC Group Study Procedures.
Aktiv komparator: Group 2 - Cognitive Intervention (CA)
Those randomized to Group 2 will receive cognitive training for 4 weeks prior to the crossover to the auditory training.
Adfærdsmæssigt: AC Group

Following completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcomes.

The auditory intervention consists of two in person visits:

Visit 1: Measurement of electrically evoked stapedius reflex thresholds (eSRTs), which do not require active participant responses CI-aided detection testing using the participant's everyday map in a sound field Assessment of threshold and comfort levels. Audio will be recorded for responses for later analysis.

Visit 2: Image-Guided Cochlear Implant Programming (IGCIP). CT-guided programming to deactivate channels with potential cross-stimulation conducted by a trained audiologist as part of routine clinical practice. The patient will also undergo speed recognition testing.

At the midpoint visit, the AC Group will crossover to the CA Group Study Procedures.

Adfærdsmæssigt: CA group

Following completion of baseline assessments, participants will be randomized to one of three arms. All arms will complete midpoint and endpoint visits, which will include speech recognition testing, fNIRS assessments, data logging, and patient-reported outcome measures.

Cognitive Intervention Procedures The cognitive intervention will be conducted remotely over 4 weeks, consisting of: Approximately 1 hour per day, 5 days per week, 20 sessions total.

Participants will complete training using a laptop or smartphone. Participants may receive in-person or remote training prior to intervention initiation.

At the midpoint visit, the CA Group will crossover to the AC Group Study Procedures.
Ingen indgriben: Group 3 - Control
Group 3 will be the control group and not receive either training.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Consonant-Nucleus-Consonant (CNC) word recognition score in best-aided listening configuration.
Tidsramme: at ~8 weeks study completion
Consonant-Nucleus-Consonant (CNC) word recognition score in best-aided listening configuration. This score is from 0 to 100% words correct.
at ~8 weeks study completion

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cochlear Implant Quality of Life (CIQOL-35)
Tidsramme: at ~8 weeks study completion
This measures assesses six domains: communication, emotional, entertainment, environment, listening effort, and social. Each domain is scored between 0 and 100 points.
at ~8 weeks study completion

Samarbejdspartnere og efterforskere

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

Sponsor

Vanderbilt University Medical Center

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 (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juni 2031

Studieafslutning (Anslået)

1. juni 2032

Datoer for studieregistrering

Først indsendt

9. maj 2026

Først indsendt, der opfyldte QC-kriterier

24. juni 2026

Først opslået (Faktiske)

1. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 260536

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

This is a feasibility study. De-identified individual participant data (IPD) collected in this study may be available to other researchers (e.g., outside the primary research group) Data may be shared with others if requested and necessary agreements are made. This is still undecided as this is a feasibility trial.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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