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Clinical Trials/NCT04207866
NCT04207866
Recruiting
Not Applicable

Evaluation of Teleconferencing in the Provision of Auditory Training Services

Sunnybrook Health Sciences Centre1 site in 1 country40 target enrollmentJune 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Impairment, Sensorineural
Sponsor
Sunnybrook Health Sciences Centre
Enrollment
40
Locations
1
Primary Endpoint
Feasibility of Teleconferencing for AT Services: In house questionnaire
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2022
End Date
January 2025
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kassandra Kaminskas

Clinical Audiologist - Cochlear Implant Program

Sunnybrook Health Sciences Centre

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

Outcomes

Primary Outcomes

Feasibility of Teleconferencing for AT Services: In house questionnaire

Time Frame: 2 years

In house questionnaire assessing benefits of using remote network for provision of services. Questionnaires asks several questions related to quality of audio-visual signal, ease of use, duration of appointments and whether or not the participants outcomes were achieved. Responses are on a likert scale (Strongly agree (1), agree, neutral, disagree, strongly disagree (5)). Higher scores mean a poorer outcome.

Secondary Outcomes

  • Speech performance(2 years)
  • Connection reliability of telepractice services(2 years)
  • Subjective Perspectives on Auditory Training Benefits(2 years)
  • Client Oriented Scale of Improvement (COSI)(2 years)

Study Sites (1)

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