N/A
N=10
Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach
Unilateral Acoustic Neuroma · Meniere's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02309099 ↗Enrolled (actual)
10
Serious AEs
20.0%
Results posted
Dec 2018
Primary outcome: Primary: Change in Consonant-Nucleus-Consonant (CNC) Words Scores Over Time — 23.6; 22; 18.8; 42.7 Percentage of words correct
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cochlear Implant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Consonant-Nucleus-Consonant (CNC) Words Scores Over Time |
23.6; 22; 18.8; 42.7; 20.4; 48.7 | — |
| PRIMARY Change in Arizona Biomedical Institute (AzBio) Sentences in Quiet Scores Over Time |
98.6; 99.7; 98.8; 99.3; 97.8; 99.7 | — |
| PRIMARY Change in AzBio Sentences in Noise Scores (S0N0) Over Time |
33.2; 44; 29.4; 41.3; 30.2; 40.3 | — |
| PRIMARY Change in AzBio Sentences in Noise Scores (S0NCI) Over Time |
76.6; 84.7; 66.6; 85; 73.4; 83.3 | — |
| PRIMARY Change in AzBio Sentences in Noise Scores (S0NContra) Over Time |
21.6; 28; 12; 38; 18; 45 | — |
| PRIMARY Change in Bamford-Kowal-Bench-Speech-in-Noise (BKB-SIN) Scores (S0N0) Over Time |
-1.3; -1; -0.9; -0.5; 0.9; -1.83 | — |
| PRIMARY Change in BKB-SIN Scores (S0NCI) Over Time |
-3.5; -6; -3.4; -5.2; -3.3; -5.33 | — |
| PRIMARY Change in BKB-SIN Scores (S0NContra) Over Time |
1.7; -1; 1.8; -2.3; 2.2; -1.3 | — |
| PRIMARY Change in Localization Root-mean-squared (RMS) Error Over Time |
40.5; 30.7; 40.2; 25.7; 37.5; 21.5 | — |
| PRIMARY Change in Reported Subjective Benefit on the Speech Domain of the Speech, Spatial and Qualities of Hearing (SSQ) Scale Over Time |
6.2; 6.1; 6.6; 5.8; 6.8; 7.1 | — |
| PRIMARY Change in Reported Subjective Benefit on the Spatial Domain of the SSQ Scale Over Time |
5.4; 6.4; 6; 7.5; 5.6; 7 | — |
| PRIMARY Change in Reported Subjective Benefit on the Qualities of Hearing Domain of the SSQ Scale Over Time |
6.4; 5; 7.9; 7.2; 6.4; 7.3 | — |
| PRIMARY Change in Reported Subjective Difficulty Frequency on the Abbreviated Profile of Hearing Aid Benefit (APHAB) Over Time |
23.3; 37.8; 23.3; 25.4; 27.8; 24.6 | — |
| SECONDARY Difference in AzBio Sentences in Quiet Scores With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time |
1; 2.3; 0; 0; 0.2; 0.7 | — |
| 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 |
-3.6; 1; -2.6; -7.7; -6.4; -6 | — |
| 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 |
1.6; -1.3; -10.2; 4.7; 4.4; -4 | — |
| 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 |
10; -2.3; 5.2; 14.7; 9.6; 12.3 | — |
| SECONDARY Difference in BKB-SIN Scores (S0N0) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time |
-1.5; -0.3; -0.8; 1; 0.3; -0.8 | — |
| SECONDARY Difference in BKB-SIN Scores (S0NCI) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time |
1.4; -0.5; 0.4; -0.2; -0.6; 0.5 | — |
| SECONDARY Difference in BKB-SIN Scores (S0NContra) With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time |
0.8; -1.5; -0.4; -3; -0.3; -1.2 | — |
| SECONDARY Difference in Localization RMS Error With the Cochlear Implant on (Plus Contralateral Ear Open) Versus Off (Contralateral Ear Alone) Over Time |
-37.5; -26.8; -31.2; -41.3; -35.9; -41.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT02309099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.