Clinical trial NCT04207866: Auditory Training Via Teleconference
Official title: Evaluation of Teleconferencing in the Provision of Auditory Training Services
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hearing Impairment, Sensorineural
Auditory; Nerve
Cochlear Implants
Rehabilitation
Keywords: Auditory Training
Teleconferencing
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a prospective observational study with sequential enrolment of 40 cochlear implant recipients. The subjects will be continuously included in the study, and will be included in the teleconferencing or on-site groups based on willingness to travel and distance from the hospital. Individuals will first be assessed by an Audiologist to determine listening goals and provide structure for auditory training sessions in house. Follow-up sessions will involve TC or FTF sessions whereby the patient will work with a CDA on skills targeted to help the patient achieve listening goals. A review session may also occur with the Audiologist following several TC or FTF sessions to assess progress and reassess current goals.
Primary purpose: TREATMENT

Brief summary: Multi-channel cochlear implants have been highly successful in restoring speech understanding to individuals with severe-to-profound hearing loss. Optimal programs facilitate access to sound but do not necessarily result in optimal performance. Practiced listening with auditory inputs is required to retrain the brain to hear using a cochlear implant. In some cases exposure to sound in everyday listening is sufficient; however, in others there is a need for the provision of auditory training (AT) by a trained professional. In these cases it is important to have regular visits with a specialist to: 1) facilitate auditory training exercises; 2) work with the family/friends to encourage optimal communication strategies in the home; 3) evaluate and assess achievement of listening goals.

This study seeks to evaluate the feasibility of providing auditory training services remotely for patient populations located outside of Toronto. This study also seeks to evaluate interindividual perspectives regarding access and benefits of these services across remote and in person sessions.

Detailed description: Individuals with severe-to-profound hearing impairment, who no longer benefit from hearing aids, are candidates for cochlear implantation. In many cases these devices provide access to sound and are successful in restoring speech understanding; however, there are instances where individuals might need additional assistance in the form of auditory training (AT). This study will involve comparison of two groups of individuals. Participants will be randomly assigned to the standard of care group OR the remote care group. Individuals who meet eligibility criteria will be contacted to assess their willingness to participate in additional auditory training (AT) sessions. These sessions will be conducted either face-to-face or via the Ontario Telehealth network as per random assignment. AT sessions will occur over the first 3 months following activation of the cochlear implant. Outcomes will be assessed using performance measures and questionnaires.

Eligibility criteria: Inclusion Criteria:

* Newly implanted subjects who might need additional auditory training supports (e.g. long-term deafened, limited communication partners etc.)
* Post-lingual onset of hearing loss
* No cognitive deficits
* English must be their native language
* Willingness to use teleconferencing methods to obtain AT services and residing \>1 hr away by car from the hospital
* Willingness to attend these appointments with a communication partner wherever possible

Exclusion Criteria:

* Onset of hearing loss prior to two years of age (prelingual hearing loss)
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array, as confirmed by medical examination and imaging including MRI
* Hearing loss of retro-cochlear or central origin
* Additional handicaps that would prevent participation in evaluations
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic device
* Active middle ear infection
* Unwillingness or inability of the candidate to comply with all investigational requirements
* History of radiation
* Patient concerns regarding their own technological skills and ability to use teleconferencing methods

Primary outcomes:
measure: Feasibility of Teleconferencing for AT Services: In house questionnaire
timeFrame: 2 years
Secondary outcomes:
measure: Speech performance
timeFrame: 2 years
measure: Speech performance
timeFrame: 2 years
measure: Speech performance
timeFrame: 2 years
measure: Connection reliability of telepractice services
timeFrame: 2 years
measure: Subjective Perspectives on Auditory Training Benefits
timeFrame: 2 years
measure: Client Oriented Scale of Improvement (COSI)
timeFrame: 2 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre - Clinical Audiologist
name: Kassandra H Kaminskas, M.Cl.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bush ML, Thompson R, Irungu C, Ayugi J. The Role of Telemedicine in Auditory Rehabilitation: A Systematic Review. Otol Neurotol. 2016 Dec;37(10):1466-1474. doi: 10.1097/MAO.0000000000001236.
citation: Cullington H, Kitterick P, DeBold L, Weal M, Clarke N, Newberry E, Aubert L. Have Cochlear Implant, Won't Have to Travel: Introducing Telemedicine to People Using Cochlear Implants. Am J Audiol. 2016 Oct 1;25(3S):299-302. doi: 10.1044/2016_AJA-16-0018.