RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-09-23
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06375278

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Advanced Bionics (FDA indications - severe to profound sensorineural hearing loss (greater than or equal to 70 dB HL)
  2. 1. HiRes Ultra 3D slim J
  3. 2. HiRes Ultra 3D midScala
  4. 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
  5. 1. CI632
  6. 2. CI622
  7. 3. CI612
  8. 3. Med-EL (moderately-severe to severe sensorineural hearing loss (greater than or equal to 65 db HL).
  9. 1. Synchrony 2 Flex soft
  10. 2. Synchrony 2 Flex28
  11. 3. Synchrony 2 Flex 24
  12. 4. Synchrony 2 Compressed
  13. 5. Synchrony 2 Medium

Contacts and Locations

Study Contact

Suhrud M Rajguru, Ph.D.
CONTACT
801-641-8180
srajguru@restorear.com
Curtis S King
CONTACT
406-414-6278
cking@restorear.com

Study Locations (Sites)

University of Miami
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: Restorear Devices LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-23
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2024-09-23
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • Cochlear Implant
  • Residual Hearing
  • Hearing Preservation

Additional Relevant MeSH Terms

  • Cochlear Implants
  • Cochlear Implantation
  • Hearing Loss