Cochlear ImplantationNCT03256097

Voice Guard Processing Evaluation in a Cohort of Subjects Implanted With the Neuro Cochlear Implant System

A study testing XDP sound processing strategy - Period 0, XDP sound processing strategy - Period 1 and VG sound processing strategy - Period 1 in people with Cochlear Implantation, run by Oticon Medical at 2 sites in United Kingdom.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Cochlear Implantation
What is being tested?: XDP sound processing strategy - Period 0, XDP sound processing strategy - Period 1 and VG sound processing strategy - Period 1
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 2 sitesUnited Kingdom
Study dates: 25 Jul 2018to 31 May 2022
Phase: Interventional
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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Individuals aged between 18 and 70 years
Individuals with post-lingual hearing loss
Individuals with no language and speech production disorders
Individuals who are native speakers of English
Individuals meeting NICE candidacy criteria for CI surgery
Individuals undergoing primary unilateral cochlear implantation

Who cannot join

Medical conditions contraindicating CI surgery
Individuals with anatomical anomalies of the auditory system
Individuals with additional mental health issues or and/or cognitive impairment

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

Queen Elizabeth Hospital, University of Birmingham NHS Hospitals Trust
Birmingham, West Midlands, B15 2TH
Addenbrooke's Hospital, Cambridge University Hospitals Trust
Cambridge, Cambridgeshire, CB2 0QQ

Other trials in United Kingdom

About this study

The study aims to compare two different cochlear implant sound processing strategies. All the participants will start off with a sound processing strategy called the XDP (extended performance). At the 3 month stage, half of the participants would randomly be selected and offered a sound processing strategy called the Voice Guard. Following that, the sound processing strategies will be altered and evaluated every 3 months at the 6th, 9th and 12th month of cochlear implant use.

Read the detailed description

Voice Guard and XDP are two different cochlear implant sound processing strategies. The Voice Guard sound coding strategy is adaptive in nature and can alter the output from the cochlear implant based on the levels of the listening environment. Hence, it can adapt to soft, medium or conversational and loud speech levels.The XDP on the other hand is not adaptive and cannot alter the cochlear implant output according to the levels of the listening environment.

In the study we are hypothesising that the Voice Guard sound processing strategy will perform better than the XDP strategy for soft (40 dB SPL) and loud (85 dB SPL) speech input levels. Speech perception scores will be recorded at 40, 65 and 85 dB SPL and a cross over study design has been adopted.

In addition, the efficacy of a cochlear implant sound reduction technique called Voice Track will also be evaluated. The Voice Track is designed to reduce the adverse effect of background noise on cochlear implant speech perception.

Conditions: Cochlear Implantation
Being tested: XDP sound processing strategy - Period 0, XDP sound processing strategy - Period 1, VG sound processing strategy - Period 1, XDP sound processing strategy - Period 2, VG sound processing strategy - Period 2
Keywords: Sound processing strategy

What participants receive

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

XDP sound processing strategy - Period 0Device
XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
XDP sound processing strategy - Period 1Device
XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
VG sound processing strategy - Period 1Device
Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
XDP sound processing strategy - Period 2Device
XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
VG sound processing strategy - Period 2Device
Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend
XDP sound processing strategy - Period 3Device
XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.
VG sound processing strategy - Period 3Device
Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend
Voice TrackDevice
Voice Track is a cochlear implant noise cancellation system which is designed to reduce the adverse effect of background noise on speech perception through cochlear implants

Study groups in NCT03256097
Study group	Role	What they receive
XDP - VG - XDP	Experimental	order of testing: XDP - VG - XDP Receives: Device: XDP sound processing strategy - Period 0; Device: XDP sound processing strategy - Period 1; Device: VG sound processing strategy - Period 2; Device: XDP sound processing strategy - Period 3; Device: Voice Track
VG - XDP - VG	Experimental	order of testing: VG - XDP - VG Receives: Device: XDP sound processing strategy - Period 0; Device: VG sound processing strategy - Period 1; Device: XDP sound processing strategy - Period 2; Device: VG sound processing strategy - Period 3; Device: Voice Track

What is being measured

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

Speech perception scores in quite and in noise
Speech perception with each intervention will be measured and a score between 0 to 100% will be obtained
Measured: 12 months

Secondary outcomes (1)

Patient reported outcome measure
Glasgow Hearing aid Benefit profile will be administered to assess patient reported benefit with each intervention
Measured: 12 months

Timeline

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

25 Jul 201831 May 2022

First posted21 Aug 2017
Study start25 Jul 2018
Primary completion31 May 2022
Study completion31 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cochlear ImplantationStudies of the same condition, open and under way.
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: Randomised
Intervention model: Crossover
Model description: A-B-A vs B-A-B
Masking: Single blind
Who is masked: Participant
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03256097
Sponsor's protocol ID: PIC_12
Status last verified: Jan 2023
First submitted: 14 Aug 2017
Last updated: 12 Jan 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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

Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
Not yet recruiting
Mi2000 TICI - Post-market Implantation Study
Hearing Loss, Binaural, Cochlear Implantation
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Active, not recruiting
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Cochlear Implant Recipients, Hearing Loss, Cochlear
Recruiting
Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
Unilateral Hearing Loss, Asymmetric Hearing Loss

All Cochlear Implantation trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Voice Guard Processing Evaluation in a Cohort of Subjects Implanted With the Neuro Cochlear Implant System
ClinicalTrials.gov ID: NCT03256097
Acronym / sponsor ID: PIC_12
Conditions: Cochlear Implantation
Keywords: Sound processing strategy
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Oticon MedicalIndustry (pharma, biotech, devices)
Study start: 25 Jul 2018 (actual)
Primary completion: 31 May 2022 (actual)
Study completion: 31 May 2022 (actual)
First posted: 21 Aug 2017 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: A-B-A vs B-A-B

Arm	Type	Receives
XDP - VG - XDP	Experimental	Device: XDP sound processing strategy - Period 0, Device: XDP sound processing strategy - Period 1, Device: VG sound processing strategy - Period 2, Device: XDP sound processing strategy - Period 3, Device: Voice Trackorder of testing: XDP - VG - XDP
VG - XDP - VG	Experimental	Device: XDP sound processing strategy - Period 0, Device: VG sound processing strategy - Period 1, Device: XDP sound processing strategy - Period 2, Device: VG sound processing strategy - Period 3, Device: Voice Trackorder of testing: VG - XDP - VG

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Individuals aged between 18 and 70 years
Individuals with post-lingual hearing loss
Individuals with no language and speech production disorders
Individuals who are native speakers of English
Individuals meeting NICE candidacy criteria for CI surgery

Key exclusion criteria (3 listed)

Medical conditions contraindicating CI surgery
Individuals with anatomical anomalies of the auditory system
Individuals with additional mental health issues or and/or cognitive impairment

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
XDP sound processing strategy - Period 0XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.	Device	VG - XDP - VG, XDP - VG - XDP
XDP sound processing strategy - Period 1XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.	Device	XDP - VG - XDP
VG sound processing strategy - Period 1Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.	Device	VG - XDP - VG
XDP sound processing strategy - Period 2XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.	Device	VG - XDP - VG
VG sound processing strategy - Period 2Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend	Device	XDP - VG - XDP
XDP sound processing strategy - Period 3XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.	Device	XDP - VG - XDP
VG sound processing strategy - Period 3Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend	Device	VG - XDP - VG
Voice TrackVoice Track is a cochlear implant noise cancellation system which is designed to reduce the adverse effect of background noise on speech perception through cochlear implants	Device	VG - XDP - VG, XDP - VG - XDP

Primary outcome

Speech perception scores in quite and in noise
Time frame: 12 months
Speech perception with each intervention will be measured and a score between 0 to 100% will be obtained

1 secondary outcome

Patient reported outcome measure
Time frame: 12 months

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 12 Jan 2023.

Related trials for Cochlear Implantation

Not yet recruitingObservational study
Mi2000 TICI Follow-up
Hearing Loss, Binaural, Cochlear Implantation
Not yet recruiting
Mi2000 TICI - Post-market Implantation Study
Hearing Loss, Binaural, Cochlear Implantation
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Active, not recruiting
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients
Cochlear Implant Recipients, Hearing Loss, Cochlear
Recruiting
Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
Unilateral Hearing Loss, Asymmetric Hearing Loss

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 Tysome principal investigator

Consultant Head and Neck Surgeon, Addenbrookes Hospital

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

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 3 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 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. 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?

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?

Speech perception scores in quite and in noise (time frame: 12 months). 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 NCT03256097.

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 12 Jan 2023.