Effectiveness of Therapy Via Telemedicine Following Cochlear Implants

Congenital Sensorineural Deafness Clinical Trial

— TACIT  

Official title:

Effectiveness of Therapy Via Telemedicine Following Cochlear Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497690
• Other study ID #: 12-1103
• Secondary ID: 5U01DC013529
• Status: Completed
• Phase: Phase 2
• Start date: September 2013
• Est. completion date: December 9, 2019

Study information

• Verified date: January 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 9, 2019
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Sensorineural Deafness
• Deafness
• Hearing Loss, Sensorineural

Intervention

Behavioral:
• Telemedicine
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.
• In-person ART
Half of subjects will undergo six months of ART administered in person. Therapy will be provided in the usual manner.

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute on Deafness and Other Communication Disorders (NIDCD), University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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