Patient-Oriented Research to Optimize Cochlear Implant Outcomes

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-95
SponsorVanderbilt University Medical Center

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Group 1 - Auditory Intervention (AC)Active comparator 2 interventions
Group B: Group 2 - Cognitive Intervention (CA)Active comparator 2 interventions
Group C: Group 3 - ControlNo intervention 0 interventions

Trial outcomes

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.

Time frame
at ~8 weeks study completion

Secondary outcomes

1

Cochlear Implant Quality of Life (CIQOL-35)

This measures assesses six domains: communication, emotional, entertainment, environment, listening effort, and social. Each domain is scored between 0 and 100 points.

Time frame
at ~8 weeks study completion

Other outcomes

Sponsors and contacts

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