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

September 27, 2021 updated by: Richard Gurgel, University of Utah

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cochlear Implants (CI) are now a well-accepted treatment for individuals with severe to profound hearing impairment. Compared to using one CI, bilateral CIs are known to provide access to some of the benefits of binaural hearing like improved speech understanding in noise (primarily due to headshadow), improved localization, reduced stress and fatigue, and improved quality of life (e.g., Dunn et al. 2012, Litovsky et al. 2012, Härkönen et al. 2016, Reeder et al. 2014, Agrawal 2008). However, a number of CI recipients are unable to or choose not to be implanted bilaterally for many reasons. Those with acoustic hearing in the contralateral ear can benefit significantly by using a hearing aid in that ear (bimodal hearing) (Ching et el. 2006, Dorman and Gifford 2010, Dorman et al. 2015, Dunn et al. 2005, Firszt et al. 2012, Illg et al. 2014, Farinetti et al. 2015).

Unilateral CI recipients do not have access to advantages of bilateral and bimodal hearing. In addition to reduced speech understanding in noise, especially when the speech source is located towards the non-CI, they can also experience increased stress and fatigue. Studies have shown that a CROS device, when worn on the contralateral, non-implanted ear, can help overcome speech understanding deficits due to head-shadow. The effect of such technology on quality of life of the CI recipient and their frequent communication partners has not been evaluated over an extended duration of use.

Study methodology:

Fifteen unilateral CI recipients will participate in this study. Testing will be conducted at the University of Utah Hospital ENT clinic. The study will comprise of 2 clinic visits separated by a take-home phase of 6 months. A designated FCP will be a part of each study visit, preferably.

Following are the test measures for CI recipients:

  • Questionnaires
  • Data logs
  • Pure-tone audiometry
  • Speech intelligibility

Following are the test measures for FCPs:

• Questionnaires

Speech testing will be conducted in a sound booth with a two speaker set-up (± 90°). AZBio sentences (Spahr et al., 2012) presented at 65 dB A will be the target stimuli. The interferer will be a multi-talker babble. The babble will be presented at an individualized level for each participant where their performance in noise in SCROS(Off)NCI configuration is half of their performance in quiet in SCROS(Off) configuration.

Study devices: For speech testing in the sound booth, a study Naida CI Q90 sound processor will be used. For the take-home phase, recipients will use their own Naida CI processor (Q70 or Q90). A Naida Link CROS will also be used for sound-booth testing as well as the take-home phase.

Workflow:

After recruiting, following will be mailed to the participants to be completed prior to the study visit and hand carried to visit 1:

For each CI subject:

(i) Informed consent form (ii) APS-SSD (Schafer et al, 2013, modified by H. Snapp, 2017) (iii) Nijmegen questionnaire (adapted from Hinderink et al, 2000)

For each CI subject's frequent communication partner:

(i) Informed consent form (ii) SOS-HEAR

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah Heath

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.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Higher Speech Understanding
Time Frame: 6 months
Unilateral CI recipients will change tohigher speech understanding scores with the CROS device in challenging listening conditions
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Advanced Bionics

Investigators

  • Principal Investigator: Richard Gurgel, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

November 6, 2019

Primary Completion (Actual)

April 8, 2021

Study Completion (Actual)

June 23, 2021

Study Registration Dates

First Submitted

February 1, 2019

First Submitted That Met QC Criteria

March 10, 2021

First Posted (Actual)

March 11, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB_00110953

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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