Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04794179
Recruitment Status : Recruiting
First Posted : March 11, 2021
Last Update Posted : March 11, 2021
Sponsor:
Collaborator:
Advanced Bionics
Information provided by (Responsible Party):
Richard Gurgel, University of Utah

Brief Summary:

The purpose of this study is to assess the effect of the Naida Link CROS device on speech understanding in challenging listening situations and on the quality of life in unilateral CI recipients and their frequent communication partners. We hypothesize that:

  1. Unilateral CI recipients will obtain higher speech understanding scores with the CROS device in challenging listening conditions
  2. Use of the CROS device will lead to positive changes in ratings on Quality of Life measures for (i) unilateral CI recipients, and (ii) their frequent communication partners

A frequent communication partner (FCP) is an individual (a family member, or a friend, or a care taker, or a significant other, or a colleague, etc.) who has at least two hours of in-person interactions with the CI recipient every week.


Condition or disease Intervention/treatment Phase
Hearing Impairment Device: Naida Link CROS Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers
Actual Study Start Date : November 6, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Naida Link CROS device
Individuals 65+ who already have Advanced Bionics CII/90K/Ultra cochlear implants will be given Naida Link CROS device to assess the effect the device has on speech understanding in challenging listening situations and on the quality of life in unilateral cochlear implant recipients and their frequent communication partners.
Device: Naida Link CROS
Individuals 65+ who already have Advanced Bionics CII/90K/Ultra cochlear implants will be given Naida Link CROS device to assess the effect the device has on speech understanding in challenging listening situations and on the quality of life in unilateral cochlear implant recipients and their frequent communication partners.




Primary Outcome Measures :
  1. Higher Speech Understanding [ Time Frame: 6 months ]
    Unilateral CI recipients will change tohigher speech understanding scores with the CROS device in challenging listening conditions


Secondary Outcome Measures :
  1. Increased Quality of Life [ Time Frame: 6 months ]
    Use of the CROS device will lead to positive changes in ratings on Quality of Life measures(using Auditory Performance and Satisfaction Scale for Single-Sided Deafness (APS-SSD) for unilateral CI recipients and their frequent communication partners. This scale asks participants to choose between a range of 0(Good Function) to 6(cannot function at all).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral recipients of Advanced Bionics CII/90K/Ultra implants
  • Ages 65+ years and above
  • At least 6 months of CI use experience
  • Current users of a Naida CI Q70 or Q90 processor
  • Do not currently use a Naida Link CROS device
  • Limited usable/aidable hearing in the contralateral ear
  • Fluent in spoken English
  • Willingness to use the CROS device regularly for the study duration
  • Willingness to follow-up on a biweekly/monthly basis

Exclusion Criteria:

  • < 6 months of CI use experience
  • < 30% sentence recognition scores in quiet with unilateral CI
  • Inability to participate in speech testing
  • Inability to follow and complete questionnaires
  • Inability to designate an FC
  • not a unilateral recipient of Advanced Bionics CII/90K/Ultra implants

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): NCT04794179


Contacts
Layout table for location contacts
Contact: Kayla Fritz 801-213-2600 kayla.fritz@hsc.utah.edu
Contact: Martin Carricaburu 801-581-3363 martin.carricaburu@hsc.utah.edu

Locations
Layout table for location information
United States, Utah
University of Utah Heath Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Kayla Fritz    801-213-2600    kayla.fritz@hsc.utah.edu   
Contact: Martin Carricaburru    801-581-3363    martin.carricaburu@hsc.utah.edu   
Principal Investigator: Richard Gurgel, MD         
Sponsors and Collaborators
University of Utah
Advanced Bionics
Investigators
Layout table for investigator information
Principal Investigator: Richard Gurgel, MD University of Utah
Publications:
Agrawal S. (2008) Spatial hearing abilities in adults with bilateral cochlear implants. PhD diss., University of Wisconsin-Madison.

Layout table for additonal information
Responsible Party: Richard Gurgel, Principle Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT04794179    
Other Study ID Numbers: IRB_00110953
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases