Investigation of Sky Automatic Technologies in Pediatrics

Not Applicable

Not yet recruiting

• Conditions: Hearing Loss
• Interventions: Device: Cochlear implant processor Sky CITM M90 (CI-5295); Diagnostic Test: French simplified matrix test (FraSimat); Behavioral: Audiologist Fitting Questionnaire; Behavioral: Patient Satisfaction Questionnaire; Behavioral: AutoSens Feedback Discussion Form

• Registration Number: NCT06400992
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Study First Posted: 2024-05-06
• Last Update Posted: 2024-05-06
• Study Start: 2024-06
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bilaterally implanted patients	Cochlear implant processor Sky CITM M90 (CI-5295)	patient with two cochlear implant in each ear
Bilaterally implanted patients	Audiologist Fitting Questionnaire	patient with two cochlear implant in each ear
Bilaterally implanted patients	Patient Satisfaction Questionnaire	patient with two cochlear implant in each ear
Bilaterally implanted patients	AutoSens Feedback Discussion Form	patient with two cochlear implant in each ear
Bimodal patients	Audiologist Fitting Questionnaire	patient with cochlear implant in one ear and fitted with hearing aid audio in the other ear
Bimodal patients	AutoSens Feedback Discussion Form	patient with cochlear implant in one ear and fitted with hearing aid audio in the other ear
Bilaterally implanted patients	French simplified matrix test (FraSimat)	patient with two cochlear implant in each ear
Bimodal patients	French simplified matrix test (FraSimat)	patient with cochlear implant in one ear and fitted with hearing aid audio in the other ear
Bimodal patients	Patient Satisfaction Questionnaire	patient with cochlear implant in one ear and fitted with hearing aid audio in the other ear

Primary Outcome Measures

Name	Time	Method
Speech in noise perception (FraSimat) Omni vs AS Target	6 months	Difference in the FraSimat score obtained with the Sky HS programmed in Omni versus the score obtained in AS Target

Secondary Outcome Measures

Name	Time	Method
Speech in noise perception (FraSimat) AS Clinic vs Omni	6 months	Difference in the FraSimat score obtained with the Sky HS programmed in AS Clinic versus the score obtained in Omni
Speech in noise perception (FraSimat) AS clinic vs AS Target	6 months	Difference in the FraSimat score obtained with the Sky HS programmed in AS Clinic versus the score obtained in AS Target
Patient satisfaction -listening	6 months	With the help of the audiologist, patients will discuss and rate listening quality in different listening situations.
Patient satisfaction - device	6 months	A patient questionnaire will be used to determine patient satisfaction with the devices
Audiologist programming modifications	6 months	An audiologist questionnaire will be used to determine the programming modifications and decisions made by the audiologist for each individual patient

Trial Locations

Locations (1)

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).; 🇫🇷 Paris, France