NCT06375278 Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
| NCT ID | NCT06375278 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Restorear Devices LLC |
| Condition | Cochlear Implants |
| Study Type | INTERVENTIONAL |
| Enrollment | 54 participants |
| Start Date | 2024-09-23 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 54 participants in total. It began in 2024-09-23 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06375278 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cochlear Implants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06375278 currently recruiting?
Yes, NCT06375278 is actively recruiting participants. Contact the research team at srajguru@restorear.com for enrollment information.
Where is the NCT06375278 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT06375278 clinical trial?
NCT06375278 is sponsored by Restorear Devices LLC. The trial plans to enroll 54 participants.