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Auditory Training Via Teleconference

Primary Purpose

Hearing Impairment, Sensorineural, Auditory; Nerve, Cochlear Implants

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Teleconferencing
Auditory training services
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Impairment, Sensorineural focused on measuring Auditory Training, Teleconferencing

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Remote AT services

In House AT

Arm Description

Experimental group will consist of participants who access auditory therapy services from a remote location. Services will be conducted with this group via teleconferencing over the Ontario Health Network.

This group will receive auditory therapy services face-to-face at the treatment site.

Outcomes

Primary Outcome Measures

Feasibility of Teleconferencing for AT Services: In house questionnaire
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 Outcome Measures

Speech performance
A battery of tests is used within the standard of care provided to cochlear implant recipients. These tests are used as a gauge of performance with the device in the real world. The first test is the Arizona Biologic (AzBio) test which is assessed in quiet and at +5 dB SNR. It is scores in percentage of words correct. Higher scores are correlated with better outcomes.
Speech performance
A battery of tests is used within the standard of care provided to cochlear implant recipients. These tests are used as a gauge of performance with the device in the real world. The second test is the Hearing in Noise (HINT) test which is assessed in quiet and at +5 dB SNR. It is scores in percentage of words correct. Higher scores are correlated with better outcomes.
Speech performance
A battery of tests is used within the standard of care provided to cochlear implant recipients. These tests are used as a gauge of performance with the device in the real world. The third test is the Consonant-Nucleus-Consonant (CNC) word test which is assessed in quiet and at +5 dB SNR. It is scores in percentage of words correct. Higher scores are correlated with better outcomes.
Connection reliability of telepractice services
Given that the remote connection can be impacted by power supply etc. a count of signal interference/breakdowns will be made over the course of the study. Different mediums may be used to provide services (e.g. Ontario Telehealth Network, Zoom, Webx) in order to provide support to CI users in a convenient manner for them.
Subjective Perspectives on Auditory Training Benefits
Participants will complete an in-house questionnaire addressing perceived benefits of the services they received as well as an assessment of audiovisual quality, disturbances in the appointment etc. for the teleconferencing group. The questionnaire uses a likert scale using descriptors of agreement (i.e. Strongly agree (1), agree, neutral, disagree, strongly disagree (5)). A higher score indicates poorer outcomes.
Client Oriented Scale of Improvement (COSI)
The COSI is a well recognized subjective questionnaire used to assess pre/post-treatment improvement in listening. It will be used to assess the participants perceived benefit of treatment prior to their first Auditory training appointment and again once they are done receiving these services. It asks the listener to generate up to 5 listening goals. It then uses subjective assessment to assess their improvement as a % of change. Reporting is also completed using a likert scale with descriptors (Worse, No difference, slightly better, better, much better). Higher percentage and greater degree of change are associated with better outcomes.

Full Information

First Posted
October 25, 2019
Last Updated
May 3, 2022
Sponsor
Sunnybrook Health Sciences Centre
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1. Study Identification

Unique Protocol Identification Number
NCT04207866
Brief Title
Auditory Training Via Teleconference
Official Title
Evaluation of Teleconferencing in the Provision of Auditory Training Services
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Impairment, Sensorineural, Auditory; Nerve, Cochlear Implants, Rehabilitation
Keywords
Auditory Training, Teleconferencing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote AT services
Arm Type
Experimental
Arm Description
Experimental group will consist of participants who access auditory therapy services from a remote location. Services will be conducted with this group via teleconferencing over the Ontario Health Network.
Arm Title
In House AT
Arm Type
Active Comparator
Arm Description
This group will receive auditory therapy services face-to-face at the treatment site.
Intervention Type
Other
Intervention Name(s)
Teleconferencing
Intervention Description
Use of video/audio stream to provide auditory training at a remote site.
Intervention Type
Other
Intervention Name(s)
Auditory training services
Intervention Description
Participants will engage in 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. Auditory training assess/reviews skills associated with but not necessarily limited to: 1) developing strategies to repair communication breakdowns; 2) listening in quiet; 3) listening in noise; 4) listening to a degraded signal.
Primary Outcome Measure Information:
Title
Feasibility of Teleconferencing for AT Services: In house questionnaire
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Speech performance
Description
A battery of tests is used within the standard of care provided to cochlear implant recipients. These tests are used as a gauge of performance with the device in the real world. The first test is the Arizona Biologic (AzBio) test which is assessed in quiet and at +5 dB SNR. It is scores in percentage of words correct. Higher scores are correlated with better outcomes.
Time Frame
2 years
Title
Speech performance
Description
A battery of tests is used within the standard of care provided to cochlear implant recipients. These tests are used as a gauge of performance with the device in the real world. The second test is the Hearing in Noise (HINT) test which is assessed in quiet and at +5 dB SNR. It is scores in percentage of words correct. Higher scores are correlated with better outcomes.
Time Frame
2 years
Title
Speech performance
Description
A battery of tests is used within the standard of care provided to cochlear implant recipients. These tests are used as a gauge of performance with the device in the real world. The third test is the Consonant-Nucleus-Consonant (CNC) word test which is assessed in quiet and at +5 dB SNR. It is scores in percentage of words correct. Higher scores are correlated with better outcomes.
Time Frame
2 years
Title
Connection reliability of telepractice services
Description
Given that the remote connection can be impacted by power supply etc. a count of signal interference/breakdowns will be made over the course of the study. Different mediums may be used to provide services (e.g. Ontario Telehealth Network, Zoom, Webx) in order to provide support to CI users in a convenient manner for them.
Time Frame
2 years
Title
Subjective Perspectives on Auditory Training Benefits
Description
Participants will complete an in-house questionnaire addressing perceived benefits of the services they received as well as an assessment of audiovisual quality, disturbances in the appointment etc. for the teleconferencing group. The questionnaire uses a likert scale using descriptors of agreement (i.e. Strongly agree (1), agree, neutral, disagree, strongly disagree (5)). A higher score indicates poorer outcomes.
Time Frame
2 years
Title
Client Oriented Scale of Improvement (COSI)
Description
The COSI is a well recognized subjective questionnaire used to assess pre/post-treatment improvement in listening. It will be used to assess the participants perceived benefit of treatment prior to their first Auditory training appointment and again once they are done receiving these services. It asks the listener to generate up to 5 listening goals. It then uses subjective assessment to assess their improvement as a % of change. Reporting is also completed using a likert scale with descriptors (Worse, No difference, slightly better, better, much better). Higher percentage and greater degree of change are associated with better outcomes.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kaye Dizon, B.Sc.
Phone
416-480-6100
Ext
85392
Email
kaye.dizon@sri.utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kassandra H Kaminskas, M.Cl.Sc.
Organizational Affiliation
Sunnybrook Health Sciences Centre - Clinical Audiologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kassandra H Kaminskas, M.Sc., M.Cl.Sc.
Phone
416-480-6100
Ext
89294
Email
kassandra.kaminskas@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Kaye Dizon, B.Sc.
Phone
416-480-6100
Ext
85392
Email
kaye.dizon@sri.utoronto.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27755363
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.
Results Reference
background
PubMed Identifier
27768192
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.
Results Reference
background

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Auditory Training Via Teleconference

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