Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology

NCT03157492 | Completed

• 2 other identifiers: 250890RE5020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

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

Conditions

Hearing Loss; Deafness

Keywords

Adult; Post-lingual; Auditory training; Communication strategies; Speech tracking; Speech recognition; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Change in Sentence Recognition CasperSent (Boothroyd, 2008)

  Percent correct scores on CasperSent topic-related recorded sentences.

  Pre-training, One-week and Two-months post-training

Secondary Outcomes (4)

• Change in Client Oriented Scale of Improvement (COSI) (Dillon, James & Ginis, 1997)

  Pre-training, One-week and Two-months post-training

• Change in Hearing Handicap Inventory (HHI) (Ventry & Weinstein,1982)

  Pre-training, One-week and Two-months post-training

• Change in Glasgow Benefit Inventory (GBI) (Robinson et al.,1996

  One-week and Two-months post-training

• Change in Nijmegen Cochlear Implant Questionnaire (NCIQ) (Hinderdink et al., 2000)

  Pre-training, One-week and Two-months post-training

Study Arms (2)

Aural Rehabilitation Group

EXPERIMENTAL

The AR Group will receive six 90-minute sessions including auditory training, informational counseling, and communication strategies.

Behavioral: Aural Rehabilitation Group

Cognitive Training Group

SHAM COMPARATOR

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

Interventions

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.

Aural Rehabilitation Group

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.

Cognitive Training Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Gallaudet University: lead
• Columbia University: collaborator
• The Cleveland Clinic: collaborator

Study Sites (5)

Gallaudet University

Washington D.C., District of Columbia, 20002, United States

Location

University of South Florida

Tampa, Florida, 33620-8150, United States

Location

University of Maryland

College Park, Maryland, 20742, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (6)

• Boothroyd, A. CasperSent: A program for computer-assisted speech perception testing and training at the sentence level. J Am Acad Rehab Audiol. 2008;41:30-50.

  BACKGROUND

• Callahan CM, Unverzagt FW, Hui SL, Perkins AJ, Hendrie HC. Six-item screener to identify cognitive impairment among potential subjects for clinical research. Med Care. 2002 Sep;40(9):771-81. doi: 10.1097/00005650-200209000-00007.

  PMID: 12218768 BACKGROUND

• Dillon H, James A, Ginis J. Client Oriented Scale of Improvement (COSI) and its relationship to several other measures of benefit and satisfaction provided by hearing aids. J Am Acad Audiol. 1997 Feb;8(1):27-43.

  PMID: 9046067 BACKGROUND

• Hinderink JB, Krabbe PF, Van Den Broek P. Development and application of a health-related quality-of-life instrument for adults with cochlear implants: the Nijmegen cochlear implant questionnaire. Otolaryngol Head Neck Surg. 2000 Dec;123(6):756-65. doi: 10.1067/mhn.2000.108203.

  PMID: 11112975 BACKGROUND

• Robinson K, Gatehouse S, Browning GG. Measuring patient benefit from otorhinolaryngological surgery and therapy. Ann Otol Rhinol Laryngol. 1996 Jun;105(6):415-22. doi: 10.1177/000348949610500601.

  PMID: 8638891 BACKGROUND

• Ventry IM, Weinstein BE. The hearing handicap inventory for the elderly: a new tool. Ear Hear. 1982 May-Jun;3(3):128-34. doi: 10.1097/00003446-198205000-00006.

  PMID: 7095321 BACKGROUND

MeSH Terms

Conditions

Hearing Loss; Deafness

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Diane M Brewer, MA

  Gallaudet University

  PRINCIPAL INVESTIGATOR

• Claire M Bernstein, PhD

  Gallaudet University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator Research Audiologist

Model Details: Participants are randomly assigned to either AR Treatment or Active (Cognitive Training) Control Group. Participants are not told they are in the control group. After the final assessment (two-month post-treatment), control group participants are offered the AR treatment.

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: May 2, 2017
• Primary Completion: October 13, 2021
• Study Completion: October 13, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)