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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03157492
Other study ID # 2508
Secondary ID 90RE5020
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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