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

NCT03256097 | Completed DMC

• 1 other identifier: PIC_12
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cochlear Implantation

Keywords

Sound processing strategy

Outcome Measures

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

  12 months

Secondary Outcomes (1)

• Patient reported outcome measure

  12 months

Study Arms (2)

XDP - VG - XDP

EXPERIMENTAL

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

VG - XDP - VG

EXPERIMENTAL

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

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.

VG - XDP - VG; XDP - VG - XDP

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.

XDP - VG - XDP

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.

VG - XDP - VG

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 - XDP - VG

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 - VG - XDP

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.

XDP - VG - XDP

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

VG - XDP - VG

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

VG - XDP - VG; XDP - VG - XDP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Medical conditions contraindicating CI surgery
• Individuals with anatomical anomalies of the auditory system
• Individuals with additional mental health issues or and/or cognitive impairment

Sponsors & Collaborators

• Oticon Medical: lead

Study Sites (2)

Addenbrooke's Hospital, Cambridge University Hospitals Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Queen Elizabeth Hospital, University of Birmingham NHS Hospitals Trust

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Study Officials

• James Tysome

  Consultant Head and Neck Surgeon, Addenbrookes Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A-B-A vs B-A-B

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 21, 2017
• Study Start: July 25, 2018
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

GB (2)