Meniere's Disease Clinical Trial
Official title:
Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach
NCT number | NCT02309099 |
Other study ID # | 14-1818 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2014 |
Est. completion date | November 8, 2017 |
Verified date | January 2018 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | November 8, 2017 |
Est. primary completion date | November 8, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Med-El Corporation |
United States,
Lustig LR, Yeagle J, Niparko JK, Minor LB. Cochlear implantation in patients with bilateral Ménière's syndrome. Otol Neurotol. 2003 May;24(3):397-403. — View Citation
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. — View Citation
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. — View Citation
Wareing MJ, O'Connor AF. The role of labyrinthectomy and cochlear implantation in Menière's disease. Ear Nose Throat J. 1997 Sep;76(9):664-6, 668, 671-2. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Difference in AzBio Sentences in Quiet Scores With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) 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 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. | Intervals within the first 12 months of device use | |
Secondary | Difference in AzBio Sentences in Noise Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) 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 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. | Intervals within the first 12 months of device use | |
Secondary | Difference in AzBio Sentences in Noise Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) 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 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. | Intervals within the first 12 months of device use | |
Secondary | Difference in AzBio Sentences in Noise Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) 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 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. | Intervals within the first 12 months of device use | |
Secondary | Difference in BKB-SIN Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) 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 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. | Intervals within the first 12 months of device use | |
Secondary | Difference in BKB-SIN Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) 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 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. | Intervals within the first 12 months of device use | |
Secondary | Difference in BKB-SIN Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) 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 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. | Intervals within the first 12 months of device use | |
Secondary | Difference in Localization RMS Error With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) 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 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. | Intervals within the first 12 months of device use |
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