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Investigating the benefit and relevance of the automatic classifier Autosense Sky in various complex acoustic conditions in CI children

Investigating the benefit and relevance of the automatic classifier Autosense Sky in various complex acoustic conditions in CI children - CI-Sky

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56575
Enrollment
12
Registered
2024-01-15
Start date
2024-03-22
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe-to-profound hearing loss

Interventions

The automatic classifier Autosense Sky is turned on in the CI processor.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Children with one or two Advanced Bionics Sky CI(s), aged between 5 and18 years, who have used their CI(s) for a period longer than 6 months.

Exclusion criteria

Exclusion criteria: Additional disabilities that are expected to interfere with VR evaluation Vision problems that prevent subjects from seeing 3D through the VR headset Epilepsy (visual effects of VR headset may trigger a seizure)

Design outcomes

Primary

MeasureTime frame
Difference in speech recognition score and sound detection/identification score in the virtual classroom setting between Autosense on and off. Self/parent-rated difference in auditory performance between the two CI settings that are tested during the take-home period (Autosense on and off).

Secondary

MeasureTime frame
Difference in speech recognition score and sound detection/identification score in the virtual classroom setting between Autosense off and remote microphone condition. Head movements and response times are logged, because they are known secondary measures of listening effort/attention.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 9, 2026