Auditory Training Via Teleconference

NCT ID: NCT04207866

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2025-01-31

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.

Conditions

Hearing Impairment, Sensorineural; Auditory; Nerve; Cochlear Implants; Rehabilitation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Remote AT services

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.

Group Type: EXPERIMENTAL

Teleconferencing

Intervention Type: OTHER

Use of video/audio stream to provide auditory training at a remote site.

Auditory training services

Intervention Type: OTHER

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.

In House AT

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

Group Type: ACTIVE_COMPARATOR

Auditory training services

Intervention Type: OTHER

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.

Interventions

Teleconferencing

Use of video/audio stream to provide auditory training at a remote site.

Intervention Type: OTHER

Auditory training services

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Kassandra Kaminskas

Clinical Audiologist - Cochlear Implant Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kassandra H Kaminskas, M.Cl.Sc.

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre - Clinical Audiologist

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Kaye Dizon, B.Sc.

Role: CONTACT

kaye.dizon@sri.utoronto.ca

416-480-6100 ext. 85392

Facility Contacts

Kassandra H Kaminskas, M.Sc., M.Cl.Sc.

Role: primary

kassandra.kaminskas@sunnybrook.ca

416-480-6100 ext. 89294

Kaye Dizon, B.Sc.

Role: backup

kaye.dizon@sri.utoronto.ca

416-480-6100 ext. 85392

References

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.

Reference Type: BACKGROUND

PMID: 27755363 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27768192 (View on PubMed)

Other Identifiers

348-2019

Identifier Type: -

Identifier Source: org_study_id