Newswires
Investigation of Sky Automatic Technologies in Pediatrics: Clinical Trial Identifier NCT06400992
2024 MAY 20 (NewsRx) -- By a
As a matter of record, on
Tracking Information
| Trial Identifier | NCT06400992 |
| First Submitted Date | |
| First Posted Date | |
| Results First Submitted Date | Not Provided |
| Results First Posted Date | Not Provided |
| Last Update Submitted Date | |
| Last Update Posted Date | |
| Primary Completion Date | |
| Start Date | |
| Current Primary Outcome Measures | •Speech in noise perception (FraSimat) Omni vs AS Target [ Time Frame: 6 months ] -- Difference in the FraSimat score obtained with the Sky HS programmed in Omni versus the score obtained in AS Target |
| Current Secondary Outcome Measures | •Speech in noise perception (FraSimat) |
| •Speech in noise perception (FraSimat) AS clinic vs AS Target [ Time Frame: 6 months ] -- Difference in the FraSimat score obtained with the Sky HS programmed in |
|
| •Patient satisfaction - device [ Time Frame: 6 months ] -- A patient questionnaire will be used to determine patient satisfaction with the devices | |
| •Patient satisfaction -listening [ Time Frame: 6 months ] -- With the help of the audiologist, patients will discuss and rate listening quality in different listening situations. | |
| •Audiologist programming modifications [ Time Frame: 6 months ] -- An audiologist questionnaire will be used to determine the programming modifications and decisions made by the audiologist for each individual patient | |
| Other Outcome Measures | Not Provided |
| Change History | Complete list of historical revisions of study NCT06400992 |
Descriptive Information
| Brief Title | Investigation of Sky Automatic Technologies in Pediatrics |
| Official Title | Investigation of Sky Automatic Technologies in Pediatrics |
| 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 |
| 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 ( |
| Study Type | Interventional |
| Study Phase | Not Applicable |
| Study Design | Allocation: Non-Randomized |
| Intervention Model: Parallel Assignment | |
| Primary Purpose: Supportive Care | |
| Masking: None (Open Label) | |
| Condition | Hearing Loss |
| Intervention | •Device: Cochlear implant processor Sky CITM M90 (CI-5295) |
| The Sky CI available to included patients (no procedures added) offers the AutoSense Sky OS technology with the three following programming conditions possible. This three condition are fitting and evaluated in noise 6 months after inclusion: Omnidirectional mode : no sound treatment AS Target : |
|
| •Device: Hearing Aid, including sound processor Phonak: |
|
| The device is fitting and programmed for home especially for the purpose research at inclusion. The Clinical map parameters will be verified according to clinical routine. The Sky Link offers the AutoSense Sky OS technology with the three following programming conditions possible. This three condition are fitting and evaluated in noise 6 months after inclusion: Omnidirectional mode : no sound treatment AS Target : |
|
| •Diagnostic Test: French simplified matrix test (FraSimat) | |
| The FraSimat speech in noise test will be tested, 6 months before inclusion in the three different fitting configurations: omni, AS clinic, AS Target. The speech will be presented from the front, noise from 180°. Noise will be presented at a fixed level of 65 dB SPL while the speech signal will be adapted to find the 50% speech reception threshold (SRT). | |
| •Behavioral: Audiologist Fitting Questionnaire | |
| After the fitting of Hearing Aid at inclusion, the audiologist will complete a questionnaire describing the fitting and justifying fitting decisions and will collect the demographic information | |
| •Behavioral: Patient Satisfaction Questionnaire | |
| The patient will be giving a Patient satisfaction Questionnaire, with questions regarding device and accessory use. The audiologist will go over the instructions for filling out the questionnaire at inclusion. Patients will be asked to complete the questionnaire and return it at the next visit, 6 months after inclusion. | |
| •Behavioral: AutoSens Feedback Discussion Form | |
| 6 months after inclusion and fitting, the audiologist discusses the use of AS clinic with the subject and completes the AS questionnaire (questionnaire on the experience of using the processor in different listening situations). | |
| Study Arms | •Experimental: Bilaterally implanted patients |
| patient with two cochlear implant in each ear | |
| Interventions: | |
| ⚬Device: Cochlear implant processor Sky CITM M90 (CI-5295) | |
| ⚬Device: Hearing Aid, including sound processor Phonak: |
|
| ⚬Diagnostic Test: French simplified matrix test (FraSimat) | |
| ⚬Behavioral: Audiologist Fitting Questionnaire | |
| ⚬Behavioral: Patient Satisfaction Questionnaire | |
| ⚬Behavioral: AutoSens Feedback Discussion Form | |
| •Experimental: Bimodal patients | |
| patient with cochlear implant in one ear and fitted with hearing aid audio in the other ear | |
| Interventions: | |
| ⚬Device: Hearing Aid, including sound processor Phonak: |
|
| ⚬Diagnostic Test: French simplified matrix test (FraSimat) | |
| ⚬Behavioral: Audiologist Fitting Questionnaire | |
| ⚬Behavioral: Patient Satisfaction Questionnaire | |
| ⚬Behavioral: AutoSens Feedback Discussion Form |
Recruitment Information
| Recruitment Status | Not yet recruiting |
| Estimated Enrollment | 20 |
| Estimated Completion Date | |
| Primary Completion Date | |
| Eligibility | 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 |
| Sex/Gender | Sexes Eligible for Study: All |
| Ages | 6 years to 16 years |
| No | |
| Contacts | Primary contact: Nathalie LOUNDON, MD, PhD, +33 1 71 39 67 82, [email protected] |
| Backup contact: Laure CHOUPEAUX, Master, 0144381711, [email protected] | |
| Listed Location Countries | |
| Removed Location Countries |
Administrative Information
| NCT Number | NCT06400992 |
| Other Study ID Numbers | APHP230143 |
| 2023-A02351-44 | |
| Has Data Monitoring Committee | Not Provided |
| Not Provided | |
| Plan to Share Data | No |
| Plan to Share Data (IPD) Description | Not Provided |
| Assistance Publique - Hopitaux de |
|
| Collaborators | |
| Investigators | Study Director: Nathalie LOUNDON, MD,PhD, APHP |
| Information Provided By | Assistance Publique - Hopitaux de |
| Verification Date |
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