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Completed

NCT Number: NCT03157492

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gallaudet University, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aural Rehabilitation Group

Behavioral

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.

Cognitive Training Group

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Gallaudet University

Other

Collaborators

  • Columbia University
  • The Cleveland Clinic

Registry information

Official study title

Enhanced Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 17, 2017
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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