Clinical trial NCT03157492: Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology
Official title: Enhanced Aural Rehabilitation for Cochlear Implant Users Via Telerehab Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Deafness
Keywords: Adult
Post-lingual
Auditory training
Communication strategies
Speech tracking
Speech recognition
Quality of Life
Lead sponsor: Gallaudet University
Sponsor class: OTHER
Collaborators: name: Columbia University
name: The Cleveland Clinic
First posted: 2017-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Sentence Recognition CasperSent (Boothroyd, 2008)
timeFrame: Pre-training, One-week and Two-months post-training
Secondary outcomes:
measure: Change in Client Oriented Scale of Improvement (COSI) (Dillon, James & Ginis, 1997)
timeFrame: Pre-training, One-week and Two-months post-training
measure: Change in Hearing Handicap Inventory (HHI) (Ventry & Weinstein,1982)
timeFrame: Pre-training, One-week and Two-months post-training
measure: Change in Glasgow Benefit Inventory (GBI) (Robinson et al.,1996
timeFrame: One-week and Two-months post-training
measure: Change in Nijmegen Cochlear Implant Questionnaire (NCIQ) (Hinderdink et al., 2000)
timeFrame: Pre-training, One-week and Two-months post-training
Other outcomes:
Locations:
city: Washington
country: United States
facility: Gallaudet University
state: District of Columbia
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: College Park
country: United States
facility: University of Maryland
state: Maryland
city: New York
country: United States
facility: Columbia University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Gallaudet University
name: Diane M Brewer, MA
role: PRINCIPAL_INVESTIGATOR
affiliation: Gallaudet University
name: Claire M Bernstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.