Hearing Impairment, SensorineuralNCT04207866
Auditory Training Via Teleconference
A study testing Teleconferencing and Auditory training services in people with Hearing Impairment, Sensorineural and Auditory; Nerve, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Impairment, Sensorineural, Auditory; Nerve, Cochlear Implants
- What is being tested?
- Teleconferencing and Auditory training services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2022to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Kassandra H Kaminskas, M.Sc., M.Cl.Sc., 416-480-6100 ext. 89294, kassandra.kaminskas@sunnybrook.ca
Kaye Dizon, B.Sc., 416-480-6100 ext. 85392, kaye.dizon@sri.utoronto.ca
About this study
Official title: Evaluation of Teleconferencing in the Provision of Auditory Training Services
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.
Read the 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.
- Being tested
- Teleconferencing, Auditory training services
- Keywords
- Auditory Training, Teleconferencing
- Medical subject headings
- Hearing Loss, Sensorineural, Vestibulocochlear Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleconferencingOther
Use of video/audio stream to provide auditory training at a remote site.
Auditory training servicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Remote AT services | Experimental | 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. Receives: Other: Teleconferencing; Other: Auditory training services |
| In House AT | Active comparator | This group will receive auditory therapy services face-to-face at the treatment site. Receives: Other: Auditory training services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (6)
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study startJun 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing Impairment, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kassandra Kaminskas, Sunnybrook Health Sciences Centre
- Investigators
- Kassandra H Kaminskas, M.Cl.Sc., Principal investigator, Sunnybrook Health Sciences Centre - Clinical Audiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207866
- Sponsor's protocol ID
- 348-2019
- Status last verified
- May 2022
- First submitted
- 25 Oct 2019
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27755363Cullington 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.
PubMed 27768192
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Teleconferencing in the Provision of Auditory Training Services
- ClinicalTrials.gov ID
- NCT04207866
- Acronym / sponsor ID
- 348-2019
- Keywords
- Auditory Training, Teleconferencing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Remote AT services | Experimental | Other: Teleconferencing, Other: Auditory training servicesExperimental 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. |
| In House AT | Active comparator | Other: Auditory training servicesThis group will receive auditory therapy services face-to-face at the treatment site. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeleconferencingUse of video/audio stream to provide auditory training at a remote site. | Other | Remote AT services |
| Auditory training servicesParticipants 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. | Other | In House AT, Remote AT services |
Primary outcome
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.
6 secondary outcomes
Speech performance
Time frame: 2 years
Speech performance
Time frame: 2 years
Speech performance
Time frame: 2 years
Connection reliability of telepractice services
Time frame: 2 years
Subjective Perspectives on Auditory Training Benefits
Time frame: 2 years
Client Oriented Scale of Improvement (COSI)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Background: PubMed 27755363Bush 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.
- Background: PubMed 27768192Cullington 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.
- Individual participant dataSharing planned: No
Related trials for Hearing Impairment, Sensorineural
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Active, not recruiting
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Cochlear Implant Recipients, Hearing Loss, Cochlear
RecruitingPhase 2
Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kassandra H Kaminskas, M.Cl.Sc. principal investigator
Sunnybrook Health Sciences Centre - Clinical Audiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleconferencing and Auditory training services in people with Hearing Impairment, Sensorineural and Auditory; Nerve, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kaye Dizon, B.Sc. (416-480-6100 ext. 85392, kaye.dizon@sri.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Teleconferencing for AT Services: In house questionnaire (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04207866, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.