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NCT03795675

CI Following VS Removal or Labyrinthectomy

Active, Not Recruiting
NAAges 18–70InterventionalTreatment
Ohio State University
~15 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:Cochlear Implant

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Sound Detection Testing
Measured over Measurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.
+2 more outcomes measured

Conditions

Vestibular Schwannoma
Meniere Disease

Explore related trials

Meniere DiseaseVestibular Schwannoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Oliver Adunka, MD · PRINCIPAL_INVESTIGATOR · Ohio State University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Have a diagnosis of a vestibular schwannoma confirmed by a physician with an MRI and/or CT scan; Or have a diagnosis of Meniere's disease by a physician
Be scheduled to undergo surgery to remove the vestibular schwannoma through translabyrinthine approach; Or be scheduled to undergo a labyrinthectomy
Be English-speaking due to objective speech perception tasks. Non-English speakers may show a reduced speech perception score due to language differences
For patients undergoing tumor removal, tumor removal must allow preservation of the auditory division of the VIIIth cranial nerve

Exclusion

Subjects with bilateral Meniere's disease or bilateral vestibular schwannomas
Inability to preserve the auditory division of the VIIIth cranial nerve during removal of vestibular schwannoma
Ossification or fibrosis of the cochlear found on preoperative imaging (CT or MRI) that precludes cochlear implantation
Active middle ear disease
Greater than 70 years of age
Vestibular schwannoma greater than 2 cm
Patient refusal of receiving pneumococcal vaccine
Any contra-indication(s) for undergoing surgery.

What this trial measures

  • Change in Sound Detection TestingMeasurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.

    Sounds that vary in pitch (frequency) will be presented in a sound field to identify hearing thresholds in decibels (dB). Participant indicates when a sound is detected/perceived when listening with the cochlear implant. The softest sound at each specific frequency (125, 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hertz (Hz)) will be recorded in dB hearing level.

  • Change in Speech Perception TestingMeasurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.

    Arizona (AZ) Bio sentences (speech perception test comprised of 660 unique sentences, presented in 33 independent lists of 20 sentences each) and the Maryland consonant-vowel nucleus-consonant (CNC) (10 phonetically balanced 50-word lists) word lists will be presented through a sound field speaker, and participant will be asked to repeat back the sentences and/or word that was heard. Background noise will be presented in conjunction with the sentences/words at various signals to noise levels (quiet \[no noise\], +0 dB and +5 dB signal to noise ratio). The percentage of sentences/words correctly repeated will be calculated for each test (AZ Bio, CNC) at each signal to noise level. Higher percentages indicate better word and sentence recognition ability.

  • Change in Sound Localization TestingMeasurements assessed 2 weeks, 1 month, 3 months, 6 months, 9 months, and 12 months post-implantation.

    Participant listens to bursts of sounds (100 trials of pink noise \[random noise having equal energy per octave and having more low-frequency components than white noise; the power per hertz decreases as the frequency increases\] presented randomly from seven speakers in a half-moon orientation and identifies which speaker presented the sounds. Two testing conditions will be evaluated (implant on, implant off). Total percentage of sounds correctly identified for each condition (0-100%) will be calculated, with a larger percentage indicating higher accuracy. Additionally, root mean square error (average of total degree of error when localizing) will be calculated for each trial.