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CompletedNCT03256097Updated Jan 12, 2023

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

An interventional study of XDP sound processing strategy - Period 0 and XDP sound processing strategy - Period 1 in Cochlear Implantation, sponsored by Oticon Medical. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-01-12.

Sponsored by Oticon Medical · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cochlear Implantation

Keywords

  • Sound processing strategy
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    XDP - VG - XDP

    order of testing: XDP - VG - XDP

    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

  • Experimental
    VG - XDP - VG

    order of testing: VG - XDP - VG

    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

Interventions

  • DeviceXDP 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.

  • DeviceXDP 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.

  • DeviceVG 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.

  • DeviceXDP 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.

  • DeviceVG 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

  • DeviceXDP 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.

  • DeviceVG 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

  • DeviceVoice 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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 12 months

06

Study locations

2 sites
  • Addenbrooke's Hospital, Cambridge University Hospitals Trust
    Cambridge, Cambridgeshire CB2 0QQ, United Kingdom
  • Queen Elizabeth Hospital, University of Birmingham NHS Hospitals Trust
    Birmingham, West Midlands B15 2TH, United Kingdom
07

Registry details

Key details

Study ID
NCT03256097
Lead sponsor
Oticon Medical
Responsible party
Sponsor
First posted
Aug 21, 2017
Start date
Jul 25, 2018
Primary completion
May 31, 2022
Completion
May 31, 2022
Last update
Jan 12, 2023

Study contacts

James Tysome
principal investigator · Consultant Head and Neck Surgeon, Addenbrookes Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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