Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology

Not Applicable

Completed

• Conditions: Hearing Loss; Deafness
• Interventions: Behavioral: Aural Rehabilitation Group; Behavioral: Cognitive Training Group

• Registration Number: NCT03157492
• Lead Sponsor: Gallaudet University

Brief Summary

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

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 Timeline

• Study Start: 2017-05-02
• Study First Submitted: 2017-05-15
• Study First Submitted QC: 2017-05-15
• Study First Posted: 2017-05-17
• Status Verified: 2021-10
• Primary Completion: 2021-10-13
• Study Completion: 2021-10-13
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aural Rehabilitation Group	Aural Rehabilitation Group	The AR Group will receive six 90-minute sessions including auditory training, informational counseling, and communication strategies.
Cognitive Training Group	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Client Oriented Scale of Improvement (COSI) (Dillon, James & Ginis, 1997)	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.
Change in Hearing Handicap Inventory (HHI) (Ventry & Weinstein,1982)	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.
Change in Glasgow Benefit Inventory (GBI) (Robinson et al.,1996	One-week and Two-months post-training	Participant rates change statements of change post-treatment.
Change in Nijmegen Cochlear Implant Questionnaire (NCIQ) (Hinderdink et al., 2000)	Pre-training, One-week and Two-months post-training	60-item questionnaire with three domains: Physical, Social and Psychological.

Trial Locations

Locations (5)

University of South Florida; 🇺🇸 Tampa, Florida, United States

Columbia University; 🇺🇸 New York, New York, United States

Gallaudet University; 🇺🇸 Washington, District of Columbia, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Maryland; 🇺🇸 College Park, Maryland, United States