Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach

NCT02309099 | Completed Results

• 1 other identifier: 14-1818
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Unilateral Acoustic Neuroma; Meniere's Disease

Keywords

Acoustic Neuroma; Vestibular Schwannoma; Meniere's Disease

Outcome Measures

Primary Outcomes (13)

• Change in Consonant-Nucleus-Consonant (CNC) Words Scores Over Time

  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.

  Intervals within the first 12 months of device use

• Change in Arizona Biomedical Institute (AzBio) Sentences in Quiet Scores Over Time

  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.

  Intervals within the first 12 months of device use

• Change in AzBio Sentences in Noise Scores (S0N0) Over Time

  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.

  Intervals within the first 12 months of device use

• Change in AzBio Sentences in Noise Scores (S0NCI) Over Time

  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.

  Intervals within the first 12 months of device use

• Change in AzBio Sentences in Noise Scores (S0NContra) Over Time

  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.

  Intervals within the first 12 months of device use

• Change in Bamford-Kowal-Bench-Speech-in-Noise (BKB-SIN) Scores (S0N0) Over Time

  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.

  Intervals within the first 12 months of device use

• Change in BKB-SIN Scores (S0NCI) Over Time

  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.

  Intervals within the first 12 months of device use

• Change in BKB-SIN Scores (S0NContra) Over Time

  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.

  Intervals within the first 12 months of device use

• Change in Localization Root-mean-squared (RMS) Error Over Time

  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.

  Intervals within the first 12 months of device use

• Change in Reported Subjective Benefit on the Speech Domain of the Speech, Spatial and Qualities of Hearing (SSQ) Scale Over Time

  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.

  Intervals within the first 12 months of device use

• Change in Reported Subjective Benefit on the Spatial Domain of the SSQ Scale Over Time

  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.

  Intervals within the first 12 months of device use

• Change in Reported Subjective Benefit on the Qualities of Hearing Domain of the SSQ Scale Over Time

  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.

  Intervals within the first 12 months of device use

• Change in Reported Subjective Difficulty Frequency on the Abbreviated Profile of Hearing Aid Benefit (APHAB) Over Time

  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.

  Intervals within the first 12 months of device use

Secondary Outcomes (8)

• Difference in AzBio Sentences in Quiet Scores With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time

  Intervals within the first 12 months of device use

• Difference in AzBio Sentences in Noise Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time

  Intervals within the first 12 months of device use

• Difference in AzBio Sentences in Noise Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time

  Intervals within the first 12 months of device use

• Difference in AzBio Sentences in Noise Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time

  Intervals within the first 12 months of device use

• Difference in BKB-SIN Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time

  Intervals within the first 12 months of device use

Study Arms (1)

Cochlear Implant

EXPERIMENTAL

Cochlear implantation of the affected ear

Device: Cochlear Implant

Interventions

Cochlear Implant DEVICE

Cochlear implantation used a treatment for single-sided deafness resultant of labyrinthectomy or a translabyrinthine surgical approach

Also known as: MED-EL CONCERT cochlear implant system, MED-EL SYNCHRONY cochlear implant system

Cochlear Implant

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Med-El Corporation: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27517, United States

Location

Related Publications (5)

• Lustig LR, Yeagle J, Niparko JK, Minor LB. Cochlear implantation in patients with bilateral Meniere's syndrome. Otol Neurotol. 2003 May;24(3):397-403. doi: 10.1097/00129492-200305000-00009.

  PMID: 12806291 BACKGROUND

• Osborn HA, Yeung R, Lin VY. Delayed cochlear implantation after surgical labyrinthectomy. J Laryngol Otol. 2012 Jan;126(1):63-5. doi: 10.1017/S0022215111002374. Epub 2011 Sep 14.

  PMID: 21914249 BACKGROUND

• Pai I, Dhar V, Kelleher C, Nunn T, Connor S, Jiang D, O'Connor AF. Cochlear implantation in patients with vestibular schwannoma: a single United Kingdom center experience. Laryngoscope. 2013 Aug;123(8):2019-23. doi: 10.1002/lary.24056. Epub 2013 Apr 24.

  PMID: 23616085 BACKGROUND

• Wareing MJ, O'Connor AF. The role of labyrinthectomy and cochlear implantation in Meniere's disease. Ear Nose Throat J. 1997 Sep;76(9):664-6, 668, 671-2. No abstract available.

  PMID: 9309909 BACKGROUND

• Zanetti D, Campovecchi CB, Pasini S, Nassif N. Simultaneous translabyrinthine removal of acoustic neuroma and cochlear implantation. Auris Nasus Larynx. 2008 Dec;35(4):562-8. doi: 10.1016/j.anl.2007.11.011. Epub 2008 Feb 19.

  PMID: 18243617 BACKGROUND

MeSH Terms

Conditions

Neuroma, Acoustic; Meniere Disease

Interventions

Cochlear Implants

Condition Hierarchy (Ancestors)

Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Nervous System Diseases; Endolymphatic Hydrops; Labyrinth Diseases

Intervention Hierarchy (Ancestors)

Neural Prostheses; Implantable Neurostimulators; Electrodes, Implanted; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Prostheses and Implants; Hearing Aids; Sensory Aids

Results Point of Contact

• Title: Dr. Meredith Rooth
• Organization: University of North Carolina at Chapel Hill

meredith_rooth@med.unc.edu

919-966-5251

Study Officials

• Kevin Brown, MD, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: December 5, 2014
• Study Start: November 1, 2014
• Primary Completion: November 8, 2017
• Study Completion: November 8, 2017
• Last Updated: January 7, 2019
• Results First Posted: December 10, 2018

Record last verified: 2018-01

Locations

US (1)