Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology

October 13, 2021 updated by: Diane Brewer, Gallaudet University

Enhanced Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology

This study evaluates the benefits of short-term training via telehealth for post-lingually deafened adult cochlear implant users. Half the participants will receive aural rehabilitation and the other half cognitive training. The hypothesis is that short-term aural rehabilitation via telerehab technology will improve outcomes for post-lingually deafened cochlear implant users

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aural rehabilitation training (AR) has been demonstrated to improve outcomes for adult cochlear implant users. There are both financial and non-financial barriers to AR service delivery including accessibility (mobility, distance and transportation problems), accommodation (time off work impossible, caring for family) and availability (limited providers in rural areas, financial constraints, and lack of transportation. In this study the investigators will measure the impact of telerehab delivery on optimizing speech recognition, communication function, goals, social participation and hearing handicap.

Twenty-four participants will be randomly assigned to one of two treatment groups: aural rehabilitation (AR) and cognitive training (CT). Participants will complete six 90-minute treatment sessions in their home or office via a telerehab platform. Participants will come to a center for three 90-minute assessment sessions: pre-treatment, 1 week, and 2 months post-treatment.

Study Type

Interventional

Enrollment (Actual)

20

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
    • District of Columbia
      • Washington, District of Columbia, United States, 20002
        • Gallaudet University
    • Florida
      • Tampa, Florida, United States, 33620-8150
        • University of South Florida
    • Maryland
      • College Park, Maryland, United States, 20742
        • University of Maryland
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Speech Tracking rate of at least 20 words per minute
  • Sentence recognition scores (CasperSent) between 10% and 85%
  • Passing score on cognitive screener (Callahan et al., 2002)

Exclusion Criteria:

  • Less than 18 years of age
  • Pre-lingually deafened
  • Prior Aural Rehabilitation with cochlear implant
  • Greater than three years post-activation of CI

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Aural Rehabilitation Group
The AR Group will receive six 90-minute sessions including auditory training, informational counseling, and communication strategies.
Behavioral: Aural Rehabilitation Group
Participants will complete sessions in their home or office via the internet. Sessions will include listening activities, informational counseling and communication strategies training. Three assessment appointments are required. The goal is to evaluate the benefit of training on performance with a cochlear implant.
SHAM_COMPARATOR: Cognitive Training Group
The Cognitive Training Group will receive six 90-minute sessions including training exercises (Ken-Ken, Sudoku, Crosswords, Word Search, Spot the Difference) to improve speed and accuracy.
Behavioral: Cognitive Training Group
The Cognitive Training Group will receive six 90-minute sessions including training exercises (Ken-Ken, Sudoku, Crosswords, Word Search, Spot the Difference) to improve speed and accuracy. Three assessment sessions are also required.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sentence Recognition CasperSent (Boothroyd, 2008)
Time Frame: Pre-training, One-week and Two-months post-training
Percent correct scores on CasperSent topic-related recorded sentences.
Pre-training, One-week and Two-months post-training

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Client Oriented Scale of Improvement (COSI) (Dillon, James & Ginis, 1997)
Time Frame: Pre-training, One-week and Two-months post-training
Participant rates hearing ability and degree of change due to treatment for three self- selected listening situations most important to them.
Pre-training, One-week and Two-months post-training
Change in Hearing Handicap Inventory (HHI) (Ventry & Weinstein,1982)
Time Frame: Pre-training, One-week and Two-months post-training
Participant rates 25 statements as true Always, Sometimes, or Never. Two subscales are Emotional and Social/situational.
Pre-training, One-week and Two-months post-training
Change in Glasgow Benefit Inventory (GBI) (Robinson et al.,1996
Time Frame: One-week and Two-months post-training
Participant rates change statements of change post-treatment.
One-week and Two-months post-training
Change in Nijmegen Cochlear Implant Questionnaire (NCIQ) (Hinderdink et al., 2000)
Time Frame: Pre-training, One-week and Two-months post-training
60-item questionnaire with three domains: Physical, Social and Psychological.
Pre-training, One-week and Two-months post-training

Collaborators and Investigators

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

Sponsor

Gallaudet University

Collaborators

Columbia University
The Cleveland Clinic

Investigators

  • Principal Investigator: Diane M Brewer, MA, Gallaudet University
  • Principal Investigator: Claire M Bernstein, PhD, Gallaudet University

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)

May 2, 2017

Primary Completion (ACTUAL)

October 13, 2021

Study Completion (ACTUAL)

October 13, 2021

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (ACTUAL)

May 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2508
  • 90RE5020 (OTHER_GRANT: NIDILRR)

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

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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