Using mild cooling during cochlear implant surgery to preserve hearing
Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
This study tests if using mild cooling during cochlear implant surgery can help people with severe hearing loss keep some of their natural hearing.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Restorear Devices LLC Industry-sponsored |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06375278 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of mild therapeutic hypothermia during cochlear implant surgery to preserve residual hearing in patients with severe to profound hearing loss. Participants will receive localized cooling therapy while undergoing the procedure, and their outcomes will be compared to a control group that does not receive the therapy. The study aims to determine both the safety and effectiveness of this approach, which has shown promise in preclinical studies. The goal is to reduce the loss of residual hearing that often occurs after cochlear implantation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe to profound sensorineural hearing loss who are scheduled for cochlear implantation.
Not a fit: Patients under 18 years of age or those who do not meet the functional hearing requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve hearing preservation for patients undergoing cochlear implantation.
How similar studies have performed: Preclinical studies have shown that localized hypothermia during cochlear implantation is effective and safe, suggesting potential for success in this clinical trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Potential participants for the study are patients who have been diagnosed with severe to profound hearing loss (HL) and plan to undergo cochlear implantation (CI) at the University of Miami. The cochlear implant surgery, pre and post-surgical care, and activation and programming of the implant are part of the participants' standard of care. If the inclusion criteria are met (age 18 years and older, equal number of men and women, profound sensorineural hearing loss (for safety study n=6) and residual hearing (see criteria below) from pre-surgical auditory brainstem response (ABR) (for efficacy study n=48), equal numbers of CI devices from all 3 manufactures and English or Spanish speakers the patient will be approached by the study personnel and will be asked to participate in the study. Exclusion Criteria: Subjects under 18 years of age. Subjects not meeting functional hearing requirements. Types of CI devices: The study will enroll patients receiving CI devices from all three manufactures. 1. Advanced Bionics (FDA indications - severe to profound sensorineural hearing loss (greater than or equal to 70 dB HL) 1. HiRes Ultra 3D slim J 2. HiRes Ultra 3D midScala 2. 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 1. CI632 2. CI622 3. CI612 3. Med-EL (moderately-severe to severe sensorineural hearing loss (greater than or equal to 65 db HL). 1. Synchrony 2 Flex soft 2. Synchrony 2 Flex28 3. Synchrony 2 Flex 24 4. Synchrony 2 Compressed 5. Synchrony 2 Medium Additional patients receiving devices not listed here may be eligible as the criteria by manufacturer change.
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Suhrud M Rajguru, Ph.D.
- Email: srajguru@restorear.com
- Phone: 801-641-8180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.