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

Cochlear Implantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256097
• Other study ID #: PIC_12
• Status: Completed
• Phase: N/A
• Start date: July 25, 2018
• Est. completion date: May 31, 2022

Study information

• Verified date: January 2023
• Source: Oticon Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Implantation

Intervention

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.
• 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

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth Hospital, University of Birmingham NHS Hospitals Trust	Birmingham	West Midlands
United Kingdom	Addenbrooke's Hospital, Cambridge University Hospitals Trust	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
Oticon Medical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	Patient reported outcome measure	Glasgow Hearing aid Benefit profile will be administered to assess patient reported benefit with each intervention	12 months