Congenital Sensorineural DeafnessPhase 2TACITNCT02497690
Effectiveness of Therapy Via Telemedicine Following Cochlear Implants
A Phase 2 study testing Telemedicine and In-person ART in people with Congenital Sensorineural Deafness, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Congenital Sensorineural Deafness
- What is being tested?
- Telemedicine and In-person ART
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 9 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- the presence of one or more significant co-morbidities
- blindness,
- severe motor impairment,
- autism,
- significant genetic/chromosomal syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
This study will assess the effectiveness of post-cochlear implant or hearing aid fitting Aural Rehabilitative Therapy (ART) delivered by means of telemedicine technology.
Read the 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.
- Conditions
- Congenital Sensorineural Deafness
- Being tested
- Telemedicine, In-person ART
- Keywords
- Cochlear Implant, Hearing Aid, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineBehavioural
Also called Telehealth
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 ARTBehavioural
Also called Standard of Care
Half of subjects will undergo six months of ART administered in person. Therapy will be provided in the usual manner.
| Study group | Role | What they receive |
|---|---|---|
| In-person ART | Active comparator | In-person approach to provide ART. Receives: Behavioral: In-person ART |
| Telehealth ART | Experimental | Telemedicine technology approach (e.g. interactive video) to provide ART. Receives: Behavioral: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startSep 2013
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Sensorineural DeafnessStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Colorado, Boulder
- Responsible party
- Sponsor
- Investigators
- James Grigsby, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02497690
- Sponsor's protocol ID
- 12-1103
- Other IDs
- 5U01DC013529
- Acronym
- TACIT
- Status last verified
- Jan 2021
- First submitted
- 29 May 2015
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Therapy Via Telemedicine Following Cochlear Implants
- ClinicalTrials.gov ID
- NCT02497690
- Acronym / sponsor ID
- TACIT / 12-1103
- Conditions
- Congenital Sensorineural Deafness
- Keywords
- Cochlear Implant, Hearing Aid, Telemedicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), University of Colorado, Boulder
- Study start
- Sep 2013 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person ART | Active comparator | Behavioral: In-person ARTIn-person approach to provide ART. |
| Telehealth ART | Experimental | Behavioral: TelemedicineTelemedicine technology approach (e.g. interactive video) to provide ART. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- the presence of one or more significant co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineAlso: TelehealthHalf 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. | Behavioural | Telehealth ART |
| In-person ARTAlso: Standard of CareHalf of subjects will undergo six months of ART administered in person. Therapy will be provided in the usual manner. | Behavioural | In-person ART |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Grigsby, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telemedicine and In-person ART in people with Congenital Sensorineural Deafness, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of subjects' language abilities. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.