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OpenTrials
Completed

NCT Number: NCT02497690

Effectiveness of Therapy Via Telemedicine Following Cochlear Implants

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

Completed

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Key information

Conditions

Congenital Sensorineural Deafness

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemedicine

Behavioral

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.

Other names: Telehealth

In-person ART

Behavioral

Half of subjects will undergo six months of ART administered in person. Therapy will be provided in the usual manner.

Other names: Standard of Care

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)
  • University of Colorado, Boulder

Registry information

Acronym: TACIT

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jul 14, 2015
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.