Effectiveness of Therapy Via Telemedicine Following Cochlear Implants

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02497690

Acronym

TACIT

Enrollment

Registered

2015-07-14

Start date

2013-09-30

Completion date

2019-12-09

Last updated

2021-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Sensorineural Deafness

Keywords

Cochlear Implant, Hearing Aid, Telemedicine

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.

Interventions

BEHAVIORALTelemedicine

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.

BEHAVIORALIn-person ART

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 6 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026