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Procedure

Safety arm for Hearing Loss

N/A

Waitlist Available

Research Sponsored by Restorear Devices LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years and older

Equal number of men and women

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3 and 6 months post-operatively

Awards & highlights

Study Summary

This trial aims to study the use of mild therapeutic hypothermia during cochlear implant surgery to see if it can help preserve any remaining hearing. They want to find out if it is safe and effective

Who is the study for?

This trial is for individuals undergoing cochlear implant surgery who are interested in trying a new method to preserve their remaining hearing. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that would exclude them from safely participating.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of using mild therapeutic hypothermia during cochlear implant surgery. It involves comparing outcomes between patients receiving this cooling therapy and those who do not (control group).See study design

What are the potential side effects?

While specific side effects are not listed, mild therapeutic hypothermia may include risks such as local discomfort or changes in ear sensation due to the cooling process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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The study aims for an equal male and female participant ratio.

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I have severe hearing loss that is not due to ear conditions.

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I have been diagnosed with severe to profound hearing loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 3 and 6 months post-operatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 3 and 6 months post-operatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3 and 6 months post-operatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cochlear Implant (CI) Device Performance Following Hypothermia Treatment

Residual Hearing

Secondary outcome measures

Electrically Evoked Compound Action Potential (ECAP)

Electrophysiological Impedance

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Safety armExperimental Treatment1 Intervention

Ascertain the safety of the system and device in patients undergoing cochlear implantation (CI). Mild therapeutic hypothermia will be delivered to the subjects during CI surgery via the ear canal.

Group II: Applicability and efficacy armPlacebo Group2 Interventions

Ascertain the applicability and efficacy of the device and system in patients undergoing cochlear implantation (CI). Half of the candidates will receive mild therapeutic hypothermia via the ear canal, and half the candidates will receive no therapy via a sham version of the device.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Restorear Devices LLCLead Sponsor

University of MiamiOTHER

903 Previous Clinical Trials

410,142 Total Patients Enrolled

11 Trials studying Hearing Loss

1,002 Patients Enrolled for Hearing Loss

National Institute on Deafness and Other Communication Disorders (NIDCD)NIH

330 Previous Clinical Trials

178,417 Total Patients Enrolled

56 Trials studying Hearing Loss

20,099 Patients Enrolled for Hearing Loss

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the ongoing medical study actively seeking participants at this time?

"As per the details on clinicaltrials.gov, recruitment for this particular investigation is presently closed. The trial was first listed on 6/1/2024 and underwent its last update on 4/16/2024. While enrollment is not active for this study currently, there are a total of 212 alternative clinical trials that are actively seeking participants at present."

Answered by AI

Recent research and studies

Ear & HearingJournal

Cochlear Implantation with Hearing Preservation Yields Significant Benefit for Speech Recognition in Complex Listening Environments

Gifford, René H., Michael F. Dorman, Henryk Skarzynski, Artur Lorens, Marek Polak, Colin L. W. Driscoll, Peter Roland, and Craig A. Buchman. 2013. “Cochlear Implantation with Hearing Preservation Yields Significant Benefit for Speech Recognition in Complex Listening Environments”. Ear & Hearing. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aud.0b013e31827e8163.

NeurosurgeryJournal

Clinical Outcomes Using Modest Intravascular Hypothermia After Acute Cervical Spinal Cord Injury

Levi, Allan D., Gizelda Casella, Barth A. Green, W. Dalton Dietrich, Steven Vanni, Jonathan Jagid, and Michael Y. Wang. 2010. “Clinical Outcomes Using Modest Intravascular Hypothermia After Acute Cervical Spinal Cord Injury”. Neurosurgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1227/01.neu.0000367557.77973.5f.

clinicaltrials.govStudy

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

2024. "Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06375278.

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