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

January 11, 2023 updated by: Oticon Medical
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: XDP - VG - XDP
order of testing: XDP - VG - XDP
Device: 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.
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.
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
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.
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
Experimental: VG - XDP - VG
order of testing: VG - XDP - VG
Device: 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.
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
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.
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.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient reported outcome measure
Time Frame: 12 months
Glasgow Hearing aid Benefit profile will be administered to assess patient reported benefit with each intervention
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oticon Medical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Tysome, Consultant Head and Neck Surgeon, Addenbrookes Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PIC_12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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