Effectiveness of Therapy Via Telemedicine Following Cochlear Implants

Study Overview
=================
Brief Summary
-----------------
This study will assess the effectiveness of post-cochlear implant or hearing aid fitting Aural Rehabilitative Therapy (ART) delivered by means of telemedicine technology.

Detailed Description
-----------------
Children with congenital sensorineural deafness can acquire relatively normal language if they undergo cochlear implantation surgery or hearing aid fitting followed by aural rehabilitation therapy in the first three to four years of life. High quality therapy, however, may not be available in many areas. This study will assess the effectiveness of post-cochlear implant or hearing aid fitting ART delivered by means of telemedicine technology. This will be accomplished primarily by evaluating subjects' language abilities using the 5th Edition of the Preschool Language Scales.

Official Title
-----------------
Effectiveness of Therapy Via Telemedicine Following Cochlear Implants

Conditions
-----------------
Congenital Sensorineural Deafness

Intervention / Treatment
-----------------
* Behavioral: Telemedicine
* Behavioral: In-person ART


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: been fitted with bilateral or unilateral cochlear implants, or bilateral hearing aids. focus on recruiting families who are members of minority groups. therapy must be provided in English. Exclusion Criteria: the presence of one or more significant co-morbidities blindness, severe motor impairment, autism, significant genetic/chromosomal syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 6 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-person ART<br>In-person approach to provide ART. | Behavioral: In-person ART<br>* Half of subjects will undergo six months of ART administered in person. Therapy will be provided in the usual manner.<br>* Other names: Standard of Care;|
| Experimental: Telehealth ART<br>Telemedicine technology approach (e.g. interactive video) to provide ART. | Behavioral: Telemedicine<br>* Half of subjects will undergo six months of ART administered via telehealth. Therapy will be provided in the usual manner, except a computer will be used to facilitate the interaction.<br>* Other names: Telehealth;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of subjects' language abilities. | Evaluation of subjects' language abilities will be conducted using the 5th Edition of the Preschool Language scales Preschool Language Scale (PLS-5) | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cochlear Implant, Hearing Aid, Telemedicine