Auditory Training Via Teleconference

NCT04207866 | Unknown

• 1 other identifier: 348-2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Auditory Training; Teleconferencing

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (6)

• Speech performance

  2 years

• Speech performance

  2 years

• Speech performance

  2 years

• Connection reliability of telepractice services

  2 years

• Subjective Perspectives on Auditory Training Benefits

  2 years

Study Arms (2)

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.

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.

Other: Auditory training services

Interventions

Teleconferencing OTHER

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

Remote AT services

Auditory training services 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; Remote AT services

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 27755363 BACKGROUND

• 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.

  PMID: 27768192 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Vestibulocochlear Nerve Diseases

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Retrocochlear Diseases; Cranial Nerve Diseases

Study Officials

• Kassandra H Kaminskas, M.Cl.Sc.

  Sunnybrook Health Sciences Centre - Clinical Audiologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaye Dizon, B.Sc.

CONTACT

416-480-6100; kaye.dizon@sri.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Audiologist - Cochlear Implant Program

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: December 23, 2019
• Study Start: June 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2025
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)