Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06375278

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

Led by Restorear Devices LLC · Updated on 2024-11-21

54

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

R

Restorear Devices LLC

Lead Sponsor

U

University of Miami

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the use of mild therapeutic hypothermia during cochlear implant surgery to preserve residual hearing in patients with severe to profound hearing loss. This interventional clinical trial aims to determine whether this therapy is safe and effective compared to standard cochlear implant procedures without hypothermia. The study focuses on improving audiological outcomes by protecting sensitive inner ear structures during surgery. Participants will undergo cochlear implant surgery with some receiving mild therapeutic hypothermia delivered via a catheter device installed in the ear canal during the operation. The trial includes groups receiving either the hypothermia therapy or standard care without cooling. The device and system are designed to provide localized, controlled mild hypothermia without modifying existing surgery or implant devices. During the study, participants will be assessed through audiometric tests such as Pure Tone Audiometry at implant activation and at 1, 3, and 12 months post-surgery. Additional measures include electrophysiological impedance and electrically evoked compound action potential evaluations during and after surgery. Researchers will monitor safety and effectiveness of the therapy through these clinical measures during follow-up visits over the course of a year.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years and older
  • Diagnosed with severe to profound sensorineural hearing loss
  • Planning to undergo cochlear implantation surgery
  • Able to speak English or Spanish
  • Equal number of men and women planned for enrollment
  • Patients with residual hearing confirmed by pre-surgical auditory brainstem response (ABR) for efficacy study
  • Use of cochlear implant devices from all three manufacturers: Advanced Bionics, Cochlear Corporation, and Med-EL
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Not meeting functional hearing requirements
  • Patients receiving cochlear implant devices not matching listed manufacturer criteria
  • Patients with hearing loss not severe or profound enough per study definitions

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Surgery day

Participants undergo cochlear implantation surgery during which a device delivering mild therapeutic hypothermia is applied inside the ear canal for hearing preservation.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 12 months

Participants are monitored for hearing preservation and device safety with audiologic and electrophysiological assessments after surgery.

Visits at initial cochlear implant activation or 1 month post-operatively, and follow-ups at 3 and 12 months post-operatively

Trial Site Locations

Total: 1 location

1

University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

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Research Team

S

Suhrud M Rajguru, Ph.D.

C

Curtis S King

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Published Research Related To This Trial

Alterations in blood-brain barrier permeability to large and small molecules and leukocyte accumulation after traumatic brain injury: effects of post-traumatic hypothermia.

George Lotocki, Juan Pablo de Rivero Vaccari, Enrique R Perez...

https://pubmed.ncbi.nlm.nih.gov/19558276

Effect of cochlear implantation on residual spiral ganglion cell count as determined by comparison with the contralateral nonimplanted inner ear in humans.

Aayesha M Khan, Ophir Handzel, Doris Damian...

https://pubmed.ncbi.nlm.nih.gov/15966525

Anatomical Correlates and Surgical Considerations for Localized Therapeutic Hypothermia Application in Cochlear Implantation Surgery.

Enrique Perez, Andrea Viziano, Zaid Al-Zaghal...

https://pubmed.ncbi.nlm.nih.gov/31318786

Neuroinflammation, oxidative stress, and blood-brain barrier (BBB) disruption in acute Utah electrode array implants and the effect of deferoxamine as an iron chelator on acute foreign body response.

Cassie Bennett, Farrah Mohammed, Anabel Álvarez-Ciara...

https://pubmed.ncbi.nlm.nih.gov/30343257