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Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach

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ClinicalTrials.gov Identifier: NCT02309099
Recruitment Status : Completed
First Posted : December 5, 2014
Results First Posted : December 10, 2018
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
Med-El Corporation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

The goal of this project is to determine whether subjects who have undergone labyrinthectomy or a translabyrinthine surgical approach as the treatment for vestibular schwannoma or Meniere's disease benefit from cochlear implantation on speech perception and localization tasks.

If the auditory nerve is able to transmit this signal effectively, then these two populations may be able to utilize the combination of electric (in the affected ear) and acoustic (in the non-affected ear) information for improved speech perception in noise and localization as reportedly experienced in other unilateral sensorineural hearing loss populations.


Condition or disease Intervention/treatment Phase
Unilateral Acoustic Neuroma Meniere's Disease Device: Cochlear Implant Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach
Actual Study Start Date : November 2014
Actual Primary Completion Date : November 8, 2017
Actual Study Completion Date : November 8, 2017


Arm Intervention/treatment
Experimental: Cochlear Implant
Cochlear implantation of the affected ear
Device: Cochlear Implant
Cochlear implantation used a treatment for single-sided deafness resultant of labyrinthectomy or a translabyrinthine surgical approach
Other Names:
  • MED-EL CONCERT cochlear implant system
  • MED-EL SYNCHRONY cochlear implant system




Primary Outcome Measures :
  1. Change in Consonant-Nucleus-Consonant (CNC) Words Scores Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Testing open-set word understanding. Recorded CNC Words lists were presented to the participant while listening to the cochlear implant alone and contralateral ear plugged/masked. Resultant score is a percentage of words correct. A higher score is better.

  2. Change in Arizona Biomedical Institute (AzBio) Sentences in Quiet Scores Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Testing open-set sentence understanding with no background noise present. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open. Resultant score is a percentage of words correct. A higher score is better.

  3. Change in AzBio Sentences in Noise Scores (S0N0) Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Testing open-set sentence understanding with concurrent background noise present at 0 decibel signal-to-noise ratio (dB SNR). Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech and noise were colocated in this condition (S0N0). Resultant score is a percentage of words correct. A higher score is better.

  4. Change in AzBio Sentences in Noise Scores (S0NCI) Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Testing open-set sentence understanding with concurrent background noise present at 0 dB SNR. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech was presented at 0 degrees azimuth and noise to the implanted side in this condition (S0NCI). Resultant score is a percentage of words correct. A higher score is better.

  5. Change in AzBio Sentences in Noise Scores (S0NContra) Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Testing open-set sentence understanding with concurrent background noise present at 0 dB SNR. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech was presented at 0 degrees azimuth and noise to the contralateral ear in this condition (S0NContra). Resultant score is a percentage of words correct. A higher score is better.

  6. Change in Bamford-Kowal-Bench-Speech-in-Noise (BKB-SIN) Scores (S0N0) Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech and noise were colocated in this condition (S0N0). Resultant score is the signal-to-noise ratio in decibels (dB SNR) at which the participant scores 50% of the target words correct. A lower score is better.

  7. Change in BKB-SIN Scores (S0NCI) Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech was presented at 0 degrees azimuth and noise to the implanted side in this condition (S0NCI). Resultant score is the signal-to-noise ratio at which the participant scores 50% of the target words correct. A lower score is better.

  8. Change in BKB-SIN Scores (S0NContra) Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open; the speech was presented at 0 degrees azimuth and noise to the contralateral ear in this condition (S0NContra). Resultant score is the signal-to-noise ratio at which the participant scores 50% of the target words correct. A lower score is better.

  9. Change in Localization Root-mean-squared (RMS) Error Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Participants identified a speech-shaped noise source presented at various presentation levels within an 11-speaker array. Participants localized the sound source with the cochlear implant on and contralateral ear open. The RMS error (degrees) was estimated; a lower degree is more accurate/better localization of the sound source.

  10. Change in Reported Subjective Benefit on the Speech Domain of the Speech, Spatial and Qualities of Hearing (SSQ) Scale Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Participants reported subjective device benefit when hearing speech in a variety of competing contexts by marking on a visual analog scale from 0 to 10, with 0 being the minimum benefit and 10 being maximal benefit. Participants based their report on daily listening with the cochlear implant on and contralateral ear open. A higher score is greater subjective benefit reported by the participant.

  11. Change in Reported Subjective Benefit on the Spatial Domain of the SSQ Scale Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Participants reported subjective device benefit for the directional, distance, and movement components of spatial hearing by marking on a visual analog scale from 0 to 10, with 0 being the minimum benefit and 10 being maximal benefit. Participants based their report on daily listening with the cochlear implant on and contralateral ear open. A higher score is greater subjective benefit reported by the participant.

  12. Change in Reported Subjective Benefit on the Qualities of Hearing Domain of the SSQ Scale Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Participants reported subjective device benefit in qualities of hearing (including ease of listening and the naturalness, clarity, and identifiability of different sounds) by marking on a visual analog scale from 0 to 10, with 0 being the minimum benefit and 10 being maximal benefit. Participants based their report on daily listening with the cochlear implant on and contralateral ear open. A higher score is greater subjective benefit reported by the participant.

  13. Change in Reported Subjective Difficulty Frequency on the Abbreviated Profile of Hearing Aid Benefit (APHAB) Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Participants reported frequency of subjective difficulty in specific listening situations. Participants based their report on daily listening with the cochlear implant on and contralateral ear open. The score is percentage of how frequently participants experience difficulty in specific listening situations, ranging from 1% (Never) to 99% (Always). A lower global score is less reported difficulty frequency by the participant.


Secondary Outcome Measures :
  1. Difference in AzBio Sentences in Quiet Scores With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Testing open-set sentence understanding with no background noise present. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech and noise were collocated in this condition. Resultant score is a difference in mean percentage of words correct between cochlear implant on versus off; a positive difference translates to a higher score with the cochlear implant on, whereas a negative difference translates to a lower score with the cochlear implant on.

  2. Difference in AzBio Sentences in Noise Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Testing open-set sentence understanding with concurrent background noise present at 0 dB SNR. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech and noise were colocated in this condition (S0N0). Resultant score is a difference in the mean percentage of words correct between cochlear implant on versus off; a positive score translates to a higher score with the cochlear implant on, whereas a negative difference translates to a lower difference with the cochlear implant on.

  3. Difference in AzBio Sentences in Noise Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Testing open-set sentence understanding with concurrent background noise present at 0 dB SNR. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech was presented at 0 degrees azimuth and noise to the implanted side in this condition (S0NCI). Resultant score is a difference in mean percentage of words correct between cochlear implant on versus off; a positive difference translates to a higher score with the cochlear implant on, whereas a negative difference translates to a lower score with the cochlear implant on.

  4. Difference in AzBio Sentences in Noise Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Testing open-set sentence understanding with concurrent background noise present at 0 dB SNR. Recorded AzBio Sentences lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech was presented at 0 degrees azimuth and noise to the contralateral ear in this condition (S0NContra). Resultant score is a difference in mean percentage of words correct between cochlear implant on versus off; a positive difference translates to a higher score with the cochlear implant on, whereas a negative difference translates to a lower score with the cochlear implant on.

  5. Difference in BKB-SIN Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech and noise were colocated in this condition (S0N0). Resultant score is a difference in the mean signal-to-noise ratio at which the participant scores 50% of the target words correct between cochlear implant on versus off; a negative difference translates to a better score with the cochlear implant on, whereas a positive difference translates to a worse score with the cochlear implant on.

  6. Difference in BKB-SIN Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech was presented at 0 degrees azimuth and noise to the implanted side in this condition (S0NCI). Resultant score is a difference in the mean signal-to-noise ratio at which the participant scores 50% of the target words correct between cochlear implant on versus off; a negative difference translates to a better score with the cochlear implant on, whereas a positive difference translates to a worse score with the cochlear implant on.

  7. Difference in BKB-SIN Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Testing open-set sentence understanding with concurrent background noise present at various levels. Recorded BKB-SIN lists were presented to the participant while listening with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone; the speech was presented at 0 degrees azimuth and noise to the contralateral ear in this condition (S0NContra). Resultant score is a difference in the mean signal-to-noise ratio at which the participant scores 50% of the target words correct between cochlear implant on versus off; a negative difference translates to a better score with the cochlear implant on, whereas a positive difference translates to a worse score with the cochlear implant on.

  8. Difference in Localization RMS Error With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time [ Time Frame: Intervals within the first 12 months of device use ]
    Participants identified a speech-shaped noise source presented at various presentation levels within an 11-speaker array. Participants localized the sound source with the cochlear implant on and contralateral ear open and also while listening with the cochlear implant off/contralateral ear alone. The RMS error (degrees) was estimated; a lower degree is more accurate/better localization of the sound source. The resultant score reported here is a difference in mean RMS error between cochlear implant on versus off; a negative difference translates to a better score with the cochlear implant on, whereas a positive difference translates to a worse score with the cochlear implant on.



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Scheduled to undergo a surgical procedure that will result in profound hearing loss in the surgical ear [unilateral vestibular schwannoma wtih planned translabyrinthine surgery or unilateral Meniere's disease with planned labyrinthectomy] [diagnosed by UNC investigators]
  2. Pure-tone average (PTA) less than or equal to 35 decibels Hearing Level (dB HL) in the contralateral ear [no evidence of retrocochlear dysfunction]
  3. Unaided consonant-nucleus-consonant (CNC) words score greater than or equal to 80% in the contralateral ear
  4. Greater than 18 years of age at implantation
  5. Realistic expectations
  6. Willing to obtain appropriate meningitis vaccinations
  7. No reported cognitive issues [pass the Mini Mental State Examination screener]
  8. Able and willing to comply with study requirements, including travel to investigational site
  9. Obtain Centers for Disease Control and Prevention (CDC) recommended meningitis vaccinations prior to surgery

Exclusion Criteria:

  1. History of implantable technology in either ear, such as a bone-conduction implant
  2. Non-native English speaker [speech perception materials presented in English]
  3. Inability to participate in follow-up procedures (unwillingness, geographic location)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309099


Locations
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United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27517
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Med-El Corporation
Investigators
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Principal Investigator: Kevin Brown, MD, PhD University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:

Publications:
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02309099     History of Changes
Other Study ID Numbers: 14-1818
First Posted: December 5, 2014    Key Record Dates
Results First Posted: December 10, 2018
Last Update Posted: January 7, 2019
Last Verified: January 2018

Keywords provided by University of North Carolina, Chapel Hill:
Acoustic Neuroma
Vestibular Schwannoma
Meniere's Disease

Additional relevant MeSH terms:
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Neuroma
Meniere Disease
Neuroma, Acoustic
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neurilemmoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Cranial Nerve Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Peripheral Nervous System Neoplasms
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases
Otorhinolaryngologic Neoplasms
Cranial Nerve Diseases
Nervous System Diseases