Clinical trial NCT02963974: Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss
Official title: Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Unilateral
Keywords: cochlear implant
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Med-El Corporation
First posted: 2016-11-15
Enrollment: 20
Sex: ALL
Minimum age (years): 42
Maximum age (years): 78
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This feasibility study evaluates whether children with unilateral, moderate to profound sensorineural hearing loss experience an improvement in speech perception, hearing in noise, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.

Detailed description: Unilateral hearing loss (UHL) is a term used to describe a substantial hearing loss in one ear and normal hearing in the contralateral ear. Despite normal hearing in one ear, these individuals experience reduced speech perception in noise, variable abilities on localization tasks, increased reports of hearing handicap, reduced quality of life, and often, they obtain limited or no benefit from conventional amplification. In the United States, the prevalence of UHL in children ranges from 0.03% to 3%, depending on the age of the child.

Cochlear implantation performed for children with bilateral, severe to profound deafness has significant impacts on several aspects of child development.

The practice of providing cochlear implants to children who have significant hearing loss in one ear is of great interest and is occurring with greater frequency as reported in case studies and small set clinical reports. The primary purpose of this feasibility study is to demonstrate the effectiveness of cochlear implantation in children, age 3 years 6 months to 6 years, 6 months, with moderate to profound UHL. Postoperative results will be evaluated with speech perception measures, localization tasks, hearing in noise tasks, and subjective reports.

Eligibility criteria: i) Inclusion Criteria

1. Unilateral moderate-to-profound sensorineural hearing loss.

   1. Unaided residual hearing thresholds that yield a pure tone average (PTA) at frequencies 500 Hz, 1 kHz and 2 kHz of ≥70 dB HL in the ear to be implanted. It is possible that subjects may have hearing at other frequencies not included in this average.
   2. Hearing thresholds in the contralateral ear of ≤25 dB HL
2. Between 3 years, 6 mos and 6 years, 6 mos of age at implantation.
3. Anatomically normal cochlear nerve
4. Cochlear anatomy that is amenable to cochlear implantation as evaluated by imaging (modality at the physician's discretion) including:

   1. Normal cochlear anatomy or
   2. Incomplete Partition Type II (IP2) with or without Enlarged Vestibular Aqueduct (EVA) or
   3. EVA with normal partitioning
5. No evidence of progressive hearing loss.
6. Willing to undergo 4 week hearing aid trial as warranted based on achieving desired audibility when fitted via real ear desired sensation level (DSL) method.
7. Aided word recognition in the ear to be implanted of 30% or less as measured with Consonant Nucleus Consonant (CNC) words (50-word list)

   1. When listening with an appropriately fit hearing aid and masking applied to the contralateral ear (Turner, 2004).
   2. Aided testing will be conducted in a sound-proof booth with the participant seated 1 meter from the sound source, facing 0° azimuth. Recorded materials will be presented at 60 dB SPL.
   3. The hearing aid output will be measured using DSL targets.
8. Realistic parental expectations: a verbal acknowledgement of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing.
9. Willing to obtain recommended meningitis vaccinations per CDC recommendations.

(9) Development and cognition within the normal range as measured by the Leiter-R test of nonverbal intelligence and cognitive abilities and the Bracken Basic Concept Scale -Revised.

(10) Parental commitment to study parameters including being able and willing to participate in evaluation schedule, involvement in prescribed therapy, and travel to investigational site and study-related activities.

ii) Exclusion Criteria

1. English is not primary language of the home

   1. Speech perception materials are presented in English
   2. Parental questionnaires are administered in English
2. Conductive hearing loss in either ear
3. Compromised auditory nerve
4. Ossification of the cochlea
5. Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)
6. History of condition that contraindicates middle or inner ear surgery or anesthesia (i.e. otitis media refractory to treatment)
7. Case of sudden sensorineural hearing loss that has not been first evaluated by a physician

Primary outcomes:
measure: Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
timeFrame: up to 24 months post-activation
measure: Mean Change in the Signal-to-noise Ratio 50 (SNR-50) From Device Off to Device on as Measured With the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) at 6 Months Post-activation
timeFrame: 6 months post-activation
measure: Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 12 Months Post-activation
timeFrame: 12 months post-activation
measure: Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 24 Months of Device Use
timeFrame: 24 months post-activation
measure: Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation
timeFrame: 3 months post-activation
measure: Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation
timeFrame: 9 months post-activation
measure: Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation
timeFrame: 18 months post-activation
measure: Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation
timeFrame: 24 months post-activation
measure: Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
timeFrame: Pre-operatively through 24 months post-activation
measure: Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire
timeFrame: Pre-operatively through 24 months post-activation
measure: Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
timeFrame: Pre-operatively through 24 months post-activation
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kevin D Brown, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arndt S, Aschendorff A, Laszig R, Beck R, Schild C, Kroeger S, Ihorst G, Wesarg T. Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol. 2011 Jan;32(1):39-47. doi: 10.1097/MAO.0b013e3181fcf271.
citation: Firszt JB, Holden LK, Reeder RM, Waltzman SB, Arndt S. Auditory abilities after cochlear implantation in adults with unilateral deafness: a pilot study. Otol Neurotol. 2012 Oct;33(8):1339-46. doi: 10.1097/MAO.0b013e318268d52d.
citation: Bess FH, Tharpe AM, Gibler AM. Auditory performance of children with unilateral sensorineural hearing loss. Ear Hear. 1986 Feb;7(1):20-6. doi: 10.1097/00003446-198602000-00005.
citation: Arndt S, Prosse S, Laszig R, Wesarg T, Aschendorff A, Hassepass F. Cochlear implantation in children with single-sided deafness: does aetiology and duration of deafness matter? Audiol Neurootol. 2015;20 Suppl 1:21-30. doi: 10.1159/000380744. Epub 2015 May 19.
citation: Kompis M, Pfiffner F, Krebs M, Caversaccio MD. Factors influencing the decision for Baha in unilateral deafness: the Bern benefit in single-sided deafness questionnaire. Adv Otorhinolaryngol. 2011;71:103-111. doi: 10.1159/000323591. Epub 2011 Mar 8.
citation: Varni JW, Limbers CA, Burwinkle TM. Impaired health-related quality of life in children and adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007 Jul 16;5:43. doi: 10.1186/1477-7525-5-43.
citation: PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available.
citation: Galvin KL, Noble W. Adaptation of the speech, spatial, and qualities of hearing scale for use with children, parents, and teachers. Cochlear Implants Int. 2013 Jun;14(3):135-41. doi: 10.1179/1754762812Y.0000000014.