Patient-Oriented Research to Optimize Cochlear Implant Outcomes

NCT07678879 | Not Yet Recruiting

• 1 other identifier: 260536
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cochlear Implant; Cochlear Implant Users; Cochlear Implant Recipients; Cochlear Implant Listeners

Keywords

CI users; CI; cochlear implant; cochlear implant user; cochlear

Outcome Measures

Primary Outcomes (1)

• Consonant-Nucleus-Consonant (CNC) word recognition score in best-aided listening configuration.

  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

Secondary Outcomes (1)

• Cochlear Implant Quality of Life (CIQOL-35)

  at ~8 weeks study completion

Study Arms (3)

Group 1 - Auditory Intervention (AC)

ACTIVE COMPARATOR

Those randomized to Group 1 will receive auditory training for 4 weeks prior to the crossover to the cognitive training.

Behavioral: AC Group; Behavioral: CA group

Group 2 - Cognitive Intervention (CA)

ACTIVE COMPARATOR

Those randomized to Group 2 will receive cognitive training for 4 weeks prior to the crossover to the auditory training.

Behavioral: AC Group; Behavioral: CA group

Group 3 - Control

NO INTERVENTION

Group 3 will be the control group and not receive either training.

Interventions

AC Group BEHAVIORAL

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.

Group 1 - Auditory Intervention (AC); Group 2 - Cognitive Intervention (CA)

CA group BEHAVIORAL

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.

Group 1 - Auditory Intervention (AC); Group 2 - Cognitive Intervention (CA)

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Central Study Contacts

Saumil Shah

CONTACT

+1 (615)421-4165; saumil.m.shah@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guy M Maness Professor in Otolaryngology Associate Professor Department of Otolaryngology-Head and Neck Surgery Associate Professor Department of Hearing and Speech Sciences

Model Details: 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).

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2032
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

US (1)