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Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation

ConditionsCochlear ImplantsCochlear ImplantationHearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRestorear Devices LLC

About this trial

The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are:

1. Is mild therapeutic hypothermia safe for use during cochlear implantation? 2. Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation?

Participants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Advanced Bionics (FDA indications - severe to profound sensorineural hearing loss (greater than or equal to 70 dB HL)

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HiRes Ultra 3D midScala

Cochlear Corporation (FDA indications - moderate to profound sensorineural hearing loss; sentence recognition less than or equal to 50% in the ear to be implanted AND less than or equal to 60% in the contralateral ear

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intra-Ear Canal Cooling Catheter

    Device

    Mild therapeutic hypothermia will be applied via the catheter device installed inside the ear canal by an experienced surgeon during cochlear implantation (CI) surgery.

Treatment groups

54 Participants
are divided into 3 treatment groups
Group A: Safety StudyExperimental treatment 1 intervention
Group B: Efficacy Study CoolingExperimental treatment 1 intervention
Group C: Efficacy Study ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Pure Tone Audiometry

Pure-tone average (PTA) of 125, 250 and 500 Hz which will be tested post-operatively in the safety and efficacy arms to measure residual hearing. A clinically significant change in hearing is greater than 10 dB HL (decibels hearing level) shift.

Time frame
At initial cochlear implant activation or 1 month post-operatively; 3 and 12 months post-operatively

Secondary outcomes

1

Electrophysiological Impedance

Per standard of care, electrophysiological impedances will be compared between groups intra- and post-operatively to measure CI device and electrode function. Impedances will be measured in the safety and efficacy arms.

Time frame
Immediately post-operatively/during surgery; at initial cochlear implant activation/1 month post-operatively; 3 and 12 months post-operatively
2

Electrically Evoked Compound Action Potential (ECAP)

Per standard of care, ECAP will be compared between groups intra- and post-operatively to test CI device function. ECAP will be measured in the safety and efficacy arms.

Time frame
Immediately post-operatively/during surgery; at initial cochlear implant activation/1 month post-operatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Restorear Devices LLC

Lead sponsor

University of Miami

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Source ClinicalTrials.gov
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