Clinical trial NCT03256097: Voice Guard Processing Evaluation in a Cohort of Subjects Implanted With the Neuro Cochlear Implant System
Official title: Voice Guard Processing Evaluation in a Cohort of Subjects Implanted With the Neuro Cochlear Implant System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cochlear Implantation
Keywords: Sound processing strategy
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2017-08-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A-B-A vs B-A-B
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Speech perception scores in quite and in noise
timeFrame: 12 months
Secondary outcomes:
measure: Patient reported outcome measure
timeFrame: 12 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital, Cambridge University Hospitals Trust
state: Cambridgeshire
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital, University of Birmingham NHS Hospitals Trust
state: West Midlands
Study officials:
affiliation: Consultant Head and Neck Surgeon, Addenbrookes Hospital
name: James Tysome
role: PRINCIPAL_INVESTIGATOR
References: