Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology
Primary Purpose
Hearing Loss, Deafness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aural Rehabilitation Group
Cognitive Training Group
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Adult, Post-lingual, Auditory training, Communication strategies, Speech tracking, Speech recognition, Quality of Life
Eligibility Criteria
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
Sites / Locations
- Gallaudet University
- University of South Florida
- University of Maryland
- Columbia University
- Cleveland Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Aural Rehabilitation Group
Cognitive Training Group
Arm Description
The AR Group will receive six 90-minute sessions including auditory training, informational counseling, and communication strategies.
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.
Outcomes
Primary Outcome Measures
Change in Sentence Recognition CasperSent (Boothroyd, 2008)
Percent correct scores on CasperSent topic-related recorded sentences.
Secondary Outcome Measures
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.
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.
Change in Glasgow Benefit Inventory (GBI) (Robinson et al.,1996
Participant rates change statements of change post-treatment.
Change in Nijmegen Cochlear Implant Questionnaire (NCIQ) (Hinderdink et al., 2000)
60-item questionnaire with three domains: Physical, Social and Psychological.
Full Information
NCT ID
NCT03157492
First Posted
May 15, 2017
Last Updated
October 13, 2021
Sponsor
Gallaudet University
Collaborators
Columbia University, The Cleveland Clinic
1. Study Identification
Unique Protocol Identification Number
NCT03157492
Brief Title
Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology
Official Title
Enhanced Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
October 13, 2021 (Actual)
Study Completion Date
October 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gallaudet University
Collaborators
Columbia University, The Cleveland Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Deafness
Keywords
Adult, Post-lingual, Auditory training, Communication strategies, Speech tracking, Speech recognition, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aural Rehabilitation Group
Arm Type
Experimental
Arm Description
The AR Group will receive six 90-minute sessions including auditory training, informational counseling, and communication strategies.
Arm Title
Cognitive Training Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Aural Rehabilitation Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training Group
Intervention Description
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 Outcome Measure Information:
Title
Change in Sentence Recognition CasperSent (Boothroyd, 2008)
Description
Percent correct scores on CasperSent topic-related recorded sentences.
Time Frame
Pre-training, One-week and Two-months post-training
Secondary Outcome Measure Information:
Title
Change in Client Oriented Scale of Improvement (COSI) (Dillon, James & Ginis, 1997)
Description
Participant rates hearing ability and degree of change due to treatment for three self- selected listening situations most important to them.
Time Frame
Pre-training, One-week and Two-months post-training
Title
Change in Hearing Handicap Inventory (HHI) (Ventry & Weinstein,1982)
Description
Participant rates 25 statements as true Always, Sometimes, or Never. Two subscales are Emotional and Social/situational.
Time Frame
Pre-training, One-week and Two-months post-training
Title
Change in Glasgow Benefit Inventory (GBI) (Robinson et al.,1996
Description
Participant rates change statements of change post-treatment.
Time Frame
One-week and Two-months post-training
Title
Change in Nijmegen Cochlear Implant Questionnaire (NCIQ) (Hinderdink et al., 2000)
Description
60-item questionnaire with three domains: Physical, Social and Psychological.
Time Frame
Pre-training, One-week and Two-months post-training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diane M Brewer, MA
Organizational Affiliation
Gallaudet University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claire M Bernstein, PhD
Organizational Affiliation
Gallaudet University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gallaudet University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20002
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33620-8150
Country
United States
Facility Name
University of Maryland
City
College Park
State/Province
Maryland
ZIP/Postal Code
20742
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
12218768
Citation
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.
Results Reference
background
PubMed Identifier
9046067
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.
Results Reference
background
PubMed Identifier
11112975
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. doi: 10.1067/mhn.2000.108203. Erratum In: Otolaryngol Head Neck Surg. 2017 Feb;156(2):391.
Results Reference
background
PubMed Identifier
8638891
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. doi: 10.1177/000348949610500601.
Results Reference
background
PubMed Identifier
7095321
Citation
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.
Results Reference
background
Learn more about this trial
Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology
We'll reach out to this number within 24 hrs