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Reverberation Effects on MED-EL Recipients

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ClinicalTrials.gov Identifier: NCT03143296
Recruitment Status : Enrolling by invitation
First Posted : May 8, 2017
Last Update Posted : May 24, 2021
Sponsor:
Collaborator:
Med-El Corporation
Information provided by (Responsible Party):
Sandra Prentiss, University of Miami

Brief Summary:
The purpose of this study is to investigate speech understanding in simulated reverberant environments with MED-EL cochlear implant recipients.

Condition or disease Intervention/treatment Phase
Hearing Loss, Sensorineural Other: Simulated reverberant environment Not Applicable

Detailed Description:
The study will determine if electrode length and coding strategy effect performance. The investigator will also study performance over time with new recipients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effects of Reverberation on Speech Understanding in MED-EL Cochlear Implant Recipients
Actual Study Start Date : August 16, 2018
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Current recipient of a Med-El cochlear implant
Participants who have received a MED-EL cochlear implant as a standard of care for treatment of hearing loss. Participants are tested at one time point with a simulated reverberant environment.
Other: Simulated reverberant environment
Reverberant environments simulate real-life situations mimicking a living room, classroom and auditorium. Each simulation lasts up to 2 hours.

Active Comparator: Future Med-El Recipient
Cochlear implant candidates not yet implanted and chose Med-El device as standard of care for treatment of hearing loss. Participants are tested at 3 time points over 6 months in a simulated reverberant environment.
Other: Simulated reverberant environment
Reverberant environments simulate real-life situations mimicking a living room, classroom and auditorium. Each simulation lasts up to 2 hours.




Primary Outcome Measures :
  1. Speech Performance [ Time Frame: Up to six months ]
    Speech performance recorded as percent correct compared to different electrode lengths.

  2. Coding strategy [ Time Frame: Two hours ]
    Speech scores, in percent correct, recorded from simulated reverberant speech tests will be compared between fine structure and envelope coding strategies.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MED-EL current cochlear implant recipients of the Flex 24 or 28 will be included
  • Minimum of 6 months experience with their cochlear implant
  • Minimum of 10 new adult Med-El recipients of the Flex 24 or Flex 28 electrodes
  • Patient at the University of Miami

Exclusion Criteria:

  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143296


Locations
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United States, Florida
University of Miami Department of Otolaryngology
Miami, Florida, United States, 33175
Sponsors and Collaborators
University of Miami
Med-El Corporation
Investigators
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Principal Investigator: Sandra Prentiss, PhD University of Miami
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Responsible Party: Sandra Prentiss, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03143296    
Other Study ID Numbers: 20170198
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: May 24, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases