Patient-Oriented Research to Optimize Cochlear Implant Outcomes

Overview

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).

Detailed description

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).

Interventions

• Behavioral 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 partic
• Behavioral 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

Primary outcome measures

• Consonant-Nucleus-Consonant (CNC) word recognition score in best-aided listening configuration. [Time frame: at ~8 weeks study completion]

Secondary outcome measures (1)

• Cochlear Implant Quality of Life (CIQOL-35) [Time frame: at ~8 weeks study completion]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT07678879 · 260536

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗