Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology

Hearing Loss Clinical Trial

Official title:

Enhanced Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157492
• Other study ID #: 2508
• Secondary ID: 90RE5020
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: October 13, 2021

Study information

• Verified date: October 2021
• Source: Gallaudet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 13, 2021
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Maryland	College Park	Maryland
United States	Columbia University	New York	New York
United States	University of South Florida	Tampa	Florida
United States	Gallaudet University	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Gallaudet University	Columbia University, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & 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.

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. — View Citation

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. — View Citation

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. Erratum in: Otolaryngol Head Neck Surg. 2017 Feb;156(2):391. — View Citation

Robinson K, Gatehouse S, Browning GG. Measuring patient benefit from otorhinolaryngological surgery and therapy. Ann Otol Rhinol Laryngol. 1996 Jun;105(6):415-22. — View Citation

Ventry IM, Weinstein BE. The hearing handicap inventory for the elderly: a new tool. Ear Hear. 1982 May-Jun;3(3):128-34. — View Citation

Outcome

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