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Clinical Trials/NCT02497690
NCT02497690
Completed
Phase 2

Effectiveness of Therapy Via Telemedicine Following Cochlear Implants

University of Colorado, Denver1 site in 1 country77 target enrollmentSeptember 2013

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Congenital Sensorineural Deafness
Sponsor
University of Colorado, Denver
Enrollment
77
Locations
1
Primary Endpoint
Evaluation of subjects' language abilities.
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
December 9, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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,
  • significant genetic/chromosomal syndrome.

Outcomes

Primary Outcomes

Evaluation of subjects' language abilities.

Time Frame: 6 months

Evaluation of subjects' language abilities will be conducted using the 5th Edition of the Preschool Language scales Preschool Language Scale (PLS-5)

Study Sites (1)

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