Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-04 @ 9:52 PM
Study NCT ID:
NCT06400992
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Sky Automatic Technologies in Pediatrics
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Investigation of Sky Automatic Technologies in Pediatrics
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SKY-MARVEL
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2023-A02351-44 | OTHER | ID-RCB | View |