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Patient-Oriented Research to Optimize Cochlear Implant Outcomes

24 juni 2026 bijgewerkt door: 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).

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37232
        • Vanderbilt University Medical Center
        • Contact:
        • Hoofdonderzoeker:
          • Aaron Moberly, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Gedragsmatig: 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.

Gedragsmatig: 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.
Actieve vergelijker: 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.
Gedragsmatig: 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.

Gedragsmatig: 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.
Geen tussenkomst: Group 3 - Control
Group 3 will be the control group and not receive either training.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Consonant-Nucleus-Consonant (CNC) word recognition score in best-aided listening configuration.
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cochlear Implant Quality of Life (CIQOL-35)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Vanderbilt University Medical Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 juni 2031

Studie voltooiing (Geschat)

1 juni 2032

Studieregistratiedata

Eerst ingediend

9 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 juni 2026

Eerst geplaatst (Werkelijk)

1 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

24 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 260536

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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