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Completed

NCT Number: NCT03256097

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

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.

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Key information

Conditions

Cochlear Implantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Addenbrooke's Hospital, Cambridge University Hospitals Trust, Cambridge, Cambridgeshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XDP sound processing strategy - Period 0

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

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

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

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

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

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

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

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Patient reported outcome measure

    Time frame: 12 months

    Glasgow Hearing aid Benefit profile will be administered to assess patient reported benefit with each intervention

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Aug 21, 2017
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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