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
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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COMPLETED
NA
21 participants
INTERVENTIONAL
2018-07-25
2022-05-31
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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XDP - VG - XDP
order of testing: XDP - VG - XDP
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.
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.
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
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.
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
VG - XDP - VG
order of testing: VG - XDP - VG
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.
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.
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.
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
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
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.
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.
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.
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.
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
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.
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Individuals with anatomical anomalies of the auditory system
* Individuals with additional mental health issues or and/or cognitive impairment
18 Years
70 Years
ALL
No
Sponsors
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Oticon Medical
INDUSTRY
Responsible Party
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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
Queen Elizabeth Hospital, University of Birmingham NHS Hospitals Trust
Birmingham, West Midlands, United Kingdom
Countries
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Other Identifiers
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PIC_12
Identifier Type: -
Identifier Source: org_study_id
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