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Monitoring of auditory and vestibular function during destructive labyrinth surgery

Monitoring of auditory and vestibular function during destructive labyrinth surgery - Vestibular implantation and inner ear preservation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55774
Enrollment
10
Registered
2016-10-19
Start date
2019-01-21
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

balance disorder bilateral vestibular loss

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patient has a disease that requires destructive surgery of the labyrinth - Patient has residual hearing that can be monitored using BERA - Patient is older than 18 years - Patient gives informed consent

Exclusion criteria

Exclusion criteria: - Patient is mentally incapacitated - Patient is carrier of any other implanted electronic device (e.g. pace-maker) - Patient has an enlarged vestibular aqueduct on routinely made preoperative CT-scan

Design outcomes

Primary

MeasureTime frame
1. Assessment of preserved auditory function when the membranous labyrinth is kept intact 2. Assessment of preserved auditory function after the membranous labyrinth is perforated with an electrode, which closes the opening directly 3. Assessment of preserved auditory function after electrode manipulation 4. Assessment of preserved auditory function after vestibular implantation

Secondary

MeasureTime frame
5. Assessment of preserved vestibular function with an electrode inside the semicircular canals 6. Assessment of damage on tissue and cellular level with histopathological examination of labyrinths after vestibular implantation

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)