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

NCT ID: NCT03256097

Last Updated: 2023-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-25

Study Completion Date

2022-05-31

Brief Summary

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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.

Detailed Description

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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

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Cochlear Implantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A-B-A vs B-A-B
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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XDP - VG - XDP

order of testing: XDP - VG - XDP

Group Type EXPERIMENTAL

XDP sound processing strategy - Period 0

Intervention Type DEVICE

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 1

Intervention Type DEVICE

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 2

Intervention Type DEVICE

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 3

Intervention Type DEVICE

XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.

Voice Track

Intervention Type DEVICE

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

VG - XDP - VG

order of testing: VG - XDP - VG

Group Type EXPERIMENTAL

XDP sound processing strategy - Period 0

Intervention Type DEVICE

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 1

Intervention Type DEVICE

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 2

Intervention Type DEVICE

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 3

Intervention Type DEVICE

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 Track

Intervention Type DEVICE

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

Interventions

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XDP sound processing strategy - Period 0

XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.

Intervention Type DEVICE

XDP sound processing strategy - Period 1

XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.

Intervention Type DEVICE

VG sound processing strategy - Period 1

Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.

Intervention Type DEVICE

XDP sound processing strategy - Period 2

XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.

Intervention Type DEVICE

VG sound processing strategy - Period 2

Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend

Intervention Type DEVICE

XDP sound processing strategy - Period 3

XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.

Intervention Type DEVICE

VG sound processing strategy - Period 3

Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend

Intervention Type DEVICE

Voice Track

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oticon Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Tysome

Role: PRINCIPAL_INVESTIGATOR

Consultant Head and Neck Surgeon, Addenbrookes Hospital

Locations

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Addenbrooke's Hospital, Cambridge University Hospitals Trust

Cambridge, Cambridgeshire, United Kingdom

Site Status

Queen Elizabeth Hospital, University of Birmingham NHS Hospitals Trust

Birmingham, West Midlands, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PIC_12

Identifier Type: -

Identifier Source: org_study_id

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