Actively Recruiting
Investigation of a 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
96 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
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).
CONDITIONS
Official Title
Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Diagnosed with severe to profound sensorineural hearing loss
- Planning to undergo cochlear implantation at the University of Miami
- Equal number of men and women participants
- Residual hearing confirmed by pre-surgical auditory brainstem response (ABR) for efficacy study
- Patients receiving cochlear implant devices from any of the three manufacturers
- English or Spanish speakers
You will not qualify if you...
- Under 18 years of age
- Not meeting functional hearing requirements
- Receiving cochlear implant devices not approved or listed by the study manufacturers (Advanced Bionics, Cochlear Corporation, Med-EL) unless manufacturer criteria change
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
S
Suhrud M Rajguru, Ph.D.
CONTACT
C
Curtis S King
CONTACT
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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