Effectiveness of Therapy Via Telemedicine Following Cochlear Implants

Phase 2

Completed

• Conditions: Congenital Sensorineural Deafness
• Interventions: Behavioral: In-person ART; Behavioral: Telemedicine

• Registration Number: NCT02497690
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2015-07-10
• Study First Posted: 2015-07-14
• Primary Completion: 2019-12-09
• Study Completion: 2019-12-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-person ART	In-person ART	In-person approach to provide ART.
Telehealth ART	Telemedicine	Telemedicine technology approach (e.g. interactive video) to provide ART.

Primary Outcome Measures

Name	Time	Method
Evaluation of subjects' language abilities.	6 months	Evaluation of subjects' language abilities will be conducted using the 5th Edition of the Preschool Language scales Preschool Language Scale (PLS-5)

Trial Locations

Locations (1)

University of Colorado; 🇺🇸 Aurora, Colorado, United States