TelemedicineTELNCT02644343

Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants

A study testing Custom Sound in people with Telemedicine, run by Cochlear at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to demonstrate the safety and efficacy of Nucleus cochlear implant programming via telecommunication. Read more about this study

Who is it for?: Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for: Telemedicine
What is being tested?: Custom Sound
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 4 sitesUnited States
Study dates: Jan 2016to 17 May 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Individuals aged greater than 12 years that are native English speakers and are capable of completing the study evaluation as deemed by their primary audiologist
Unilateral or bilateral cochlear implant recipients of a CI24RE, CI422 or CI500 series implant who are in possession of a backup sound processor
A minimum of 12 months' experience with a CP800 or CP900 series sound processor, and current MAP programmed within 12 months prior to Visit 1
Willingness to participate in and to comply with all requirements of the protocol
Able to demonstrate protocol competence as confirmed by primary audiologist

Who cannot join

Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations of remote service delivery
Unwillingness or inability of the candidate to comply with all investigational requirements
Additional handicaps that would prevent or restrict participation in the audiological evaluations
Inability to demonstrate basic technological skills for simple computer-based tasks and device connecting after training by primary audiologist

Trial locations and contacts

4 sites in 1 country.

United States4 sites

University of Michigan
Ann Arbor, Michigan, 48108
University of North Carolina
Chapel Hill, North Carolina, 27713
Rocky Mountain Ear Center
Englewood, Colorado, 80113
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

The purpose of this study is to demonstrate the safety and efficacy of Nucleus cochlear implant programming via telecommunication.

Read the detailed description

Cochlear implant recipients will undergo remapping at a location remote from their audiologist via telehealth. Audiologists will use an internet meeting platform to remotely log into the subject's computer and control the programming software. Remote programming sessions will be completed both with and without the assistance of a trained facilitator, and speech understanding will be tested in between mapping sessions.

Conditions: Telemedicine
Being tested: Custom Sound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Custom SoundDevice
Custom Sound is the programming software used to program Nucleus cochlear implants.

Study groups in NCT02644343
Study group	Role	What they receive
Remote Programming Group	Experimental	Subjects will undergo remote programming of Nucleus cochlear implants via Custom Sound software using an online interactive meeting platform. The intervention is the programming of the cochlear implant, the experimental aspect is the remote delivery method. Receives: Device: Custom Sound

What is being measured

The primary outcome is the main question the study is designed to answer.

Speech Perception on Monosyllabic Word Test, CNC Words
Subjects will listen to and repeat monosyllabic words from the Consonant Nucleus Consonant word test measured by percentage of words correct to examine their speech perception abilities after each remote programming session.
Measured: 2-4 weeks post remote programming session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201617 May 2017

First posted31 Dec 2015 (estimated)
Study startJan 2016
Primary completion17 May 2017
Study completion17 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for TelemedicineStudies of the same condition, open and under way.
More trials run by CochlearThe 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02644343
Sponsor's protocol ID: CAM 5650
Acronym: TEL
Status last verified: Nov 2020
First submitted: 28 Dec 2015
Last updated: 24 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014.
PubMed 15035561
PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available.
PubMed 14485785
Wesarg T, Wasowski A, Skarzynski H, Ramos A, Falcon Gonzalez JC, Kyriafinis G, Junge F, Novakovich A, Mauch H, Laszig R. Remote fitting in Nucleus cochlear implant recipients. Acta Otolaryngol. 2010 Dec;130(12):1379-88. doi: 10.3109/00016489.2010.492480. Epub 2010 Jun 30.
PubMed 20586675
McElveen JT Jr, Blackburn EL, Green JD Jr, McLear PW, Thimsen DJ, Wilson BS. Remote programming of cochlear implants: a telecommunications model. Otol Neurotol. 2010 Sep;31(7):1035-40. doi: 10.1097/MAO.0b013e3181d35d87.
PubMed 20147864

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants
ClinicalTrials.gov ID: NCT02644343
Acronym / sponsor ID: TEL / CAM 5650
Conditions: Telemedicine
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: CochlearIndustry (pharma, biotech, devices)
Study start: Jan 2016
Primary completion: 17 May 2017 (actual)
Study completion: 17 May 2017 (actual)
First posted: 31 Dec 2015 (estimated)
Results: Posted 10 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to demonstrate the safety and efficacy of Nucleus cochlear implant programming via telecommunication.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Remote Programming Group	Experimental	Device: Custom SoundSubjects will undergo remote programming of Nucleus cochlear implants via Custom Sound software using an online interactive meeting platform. The intervention is the programming of the cochlear implant, the experimental aspect is the remote delivery method.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Individuals aged greater than 12 years that are native English speakers and are capable of completing the study evaluation as deemed by their primary audiologist
Unilateral or bilateral cochlear implant recipients of a CI24RE, CI422 or CI500 series implant who are in possession of a backup sound processor
A minimum of 12 months' experience with a CP800 or CP900 series sound processor, and current MAP programmed within 12 months prior to Visit 1
Willingness to participate in and to comply with all requirements of the protocol
Able to demonstrate protocol competence as confirmed by primary audiologist

Key exclusion criteria (4 listed)

Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations of remote service delivery
Unwillingness or inability of the candidate to comply with all investigational requirements
Additional handicaps that would prevent or restrict participation in the audiological evaluations
Inability to demonstrate basic technological skills for simple computer-based tasks and device connecting after training by primary audiologist

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
Custom SoundCustom Sound is the programming software used to program Nucleus cochlear implants.	Device	Remote Programming Group

Primary outcome

Speech Perception on Monosyllabic Word Test, CNC Words
Time frame: 2-4 weeks post remote programming session
Subjects will listen to and repeat monosyllabic words from the Consonant Nucleus Consonant word test measured by percentage of words correct to examine their speech perception abilities after each remote programming session.

Results and safety

Results posted to the registry on 10 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Remote Programming Group	40	39

Primary outcome: Speech Perception on Monosyllabic Word Test, CNC Words

Time frame: 2-4 weeks post remote programming session. Mean (Standard Deviation). Unit: percentage of words correct

Measure	Remote Programming Group n = 39
Live Audiologist MAP	70.5 (18.6)
Facilitated Remote MAP	72.4 (18.7)
Unassisted Remote MAP	72.5 (21.3)

Adverse events

Time frame: 1 year, 5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Remote Programming Group	0 of 40 (0%)	1 of 40 (2.5%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15035561Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J Audiol. 2004 Feb;43(2):85-99. doi: 10.1080/14992020400050014.
Background: PubMed 14485785PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available.
Background: PubMed 20586675Wesarg T, Wasowski A, Skarzynski H, Ramos A, Falcon Gonzalez JC, Kyriafinis G, Junge F, Novakovich A, Mauch H, Laszig R. Remote fitting in Nucleus cochlear implant recipients. Acta Otolaryngol. 2010 Dec;130(12):1379-88. doi: 10.3109/00016489.2010.492480. Epub 2010 Jun 30.
Background: PubMed 20147864McElveen JT Jr, Blackburn EL, Green JD Jr, McLear PW, Thimsen DJ, Wilson BS. Remote programming of cochlear implants: a telecommunications model. Otol Neurotol. 2010 Sep;31(7):1035-40. doi: 10.1097/MAO.0b013e3181d35d87.

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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.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Custom Sound in people with Telemedicine, run by Cochlear at 4 sites 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 5 inclusion and 4 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 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Speech Perception on Monosyllabic Word Test, CNC Words (time frame: 2-4 weeks post remote programming session). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02644343, which also lists 4 linked publications.

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 24 Nov 2020.