Clinical trial NCT06400992: Investigation of Sky Automatic Technologies in Pediatrics
Official title: Investigation of Sky Automatic Technologies in Pediatrics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Keywords: Hearing Loss
cochlear implant
hearing aid
hearing device
hearing system
Simplified French Matrix Test
Noise block
background noise
target cochlear implant
pediatric cochlear implant processor
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Advanced Bionics AG
First posted: 2024-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The hypothesis of this research is that the AS Target setting provides the best estimate of the settings required to optimize listening in noise. As such, it is expected that speech in noise performance will be best in the AS Target condition, followed by the AS Clinic condition, and the Omni condition will be the least favourable for speech in noise performance.

Detailed description: The ability to hear speech in noise is particularly important for children, as they are often in complex listening situations like classrooms or playgrounds. In children with hearing loss, the ability to understand speech in noise is further degraded not only by decreased audibility of speech sounds, but also additionally by the distortion spectral and temporal processing cues, and reduced binaural processing abilities. Cochlear implant manufacturers have introduced a number of technologies designed to improve speech recognition in background noise. Sound processing algorithms use a variety of strategies to facilitate listening in noise, and research has shown that these advances do lead to improved performance.

AutoSense Sky OS 3.0 (AutoSense Sky OS, AS) is an automatic auditory scene classification system specifically designed for children's typical listening situations, like classrooms and playgrounds. This technology is available in the new Sky CI M90 (Sky CI), which is the latest generation of sound processor (SP) from Advanced Bionics, designed for children.

This algorithm is also available in the Sky Link M90 hearing aid (Sky Link). This means that bimodal patients, using one Sky Link and one Sky CI can benefit from AutoSense Sky OS in addition to children with two Sky CI. The combination of the two hearing devices (HD) tested in this research, whether it be two Sky CI or one Sky CI and one Sky Link, will be referred to as the Sky Hearing System (Sky HS).

As usual in standard care, children with Sky HS can have their hearing system programmed in three ways (at the discretion of the clinician):

1. Omnidirectional mode, in which the AutoSense Sky OS is deactivated and no modifications are made by the clinician (no sound treatment)
2. AS Target, in which the AutoSense Sky OS is active and programmed with the parameters suggested by the programming software (Target) and no modifications are made by the clinician
3. AS clinic, in which the AutoSense Sky OS is active, and settings have been modified by the clinician (mixed setting).

The goal of this research is to compare speech in noise perception in each of those three possible programming conditions used in the standard care. The hypothesis of this research is that the AS Target setting provides the best estimate of the settings required to optimize listening in noise. As such, it is expected that speech in noise performance will be best in the AS Target condition.

Eligibility criteria: Inclusion Criteria:

* Be between 6 and 16 years of age at the time of inclusion
* Use spoken French as their primary mode of communication
* Ability to perform the Simplified French Matrix test in Noise
* Bimodal group: use the Sky CI processor or be eligible for a Sky CI processor upgrade on one side and use a contralateral hearing aid
* Bilaterally implanted group: use two Sky CI processors or be eligible for an upgrade to two Sky CI processors
* Obtain signed consent from legal guardian(s)
* Be enrolled in a health insurance plan or eligible for coverage

Exclusion Criteria:

* Severe neurological pathology identified prior to inclusion identified by MRI + /- neuro-pediatric workup
* Severe cognitive, psychiatric, or developmental disabilities identified prior to inclusion
* Family does not understand French

Primary outcomes:
measure: Speech in noise perception (FraSimat)
timeFrame: 6 months
Secondary outcomes:
measure: Speech in noise perception (FraSimat)
timeFrame: 6 months
measure: Speech in noise perception (FraSimat)
timeFrame: 6 months
measure: Patient satisfaction - device
timeFrame: 6 months
measure: Patient satisfaction -listening
timeFrame: 6 months
measure: Audiologist programming modifications
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Audiophonology Unit of the Ear, Nose and Throat (ENT) Department ("Oto-rhino-laryngologie (ORL) et chirurgie cervico-faciale") at the Necker-Enfants Malades hospital (AP-HP).
Study officials:
affiliation: APHP
name: Nathalie LOUNDON, MD,PhD
role: STUDY_DIRECTOR
References: