Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-07-07
Study Completion Date
2030-05-30
Brief Summary
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The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness.
The main questions it aims to answer are:
* Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers?
* Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers?
Participants will receive a cochlear implant and be followed until they are five years old. During those five years, the investigators will program the device and monitor auditory development.
Children will be asked to:
* Undergo cochlear implantation
* Wear their cochlear implant processor whenever they are awake.
* Participate in traditional hearing tests
* Participate in traditional hearing testing
* Participate in localization testing
* Participate in hearing in noise testing
* Participate in word recognition testing
* Participate in speech, language, and educational evaluations
The researchers will compare results to children with typical hearing in both ears and children with single-sided deafness who have not received an implant to observe any differences between the groups.
The main questions it aims to answer are:
* Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers?
* Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers?
Participants will receive a cochlear implant and be followed until they are five years old. During those five years, the investigators will program the device and monitor auditory development.
Children will be asked to:
* Undergo cochlear implantation
* Wear their cochlear implant processor whenever they are awake.
* Participate in traditional hearing tests
* Participate in traditional hearing testing
* Participate in localization testing
* Participate in hearing in noise testing
* Participate in word recognition testing
* Participate in speech, language, and educational evaluations
The researchers will compare results to children with typical hearing in both ears and children with single-sided deafness who have not received an implant to observe any differences between the groups.
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Detailed Description
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Cochlear implantation is an FDA-approved option for children with single-sided deafness (SSD) who are over the age of five years. It has been well established that early implantation is advantageous for children with bilateral hearing loss as it takes advantage of the narrow window of neural plasticity. Research has yet to show the ideal age for implantation in children with SSD but considering the known impacts of age at implantation and duration of deafness on cochlear implant (CI) outcomes, five years is likely a late age for implantation in a child with congenital SSD. The purpose of this prospective clinical trial is to evaluate the safety and effectiveness of cochlear implantation in infants and toddlers with SSD.
Twenty (20) infants and Toddlers with SSD who are under the age of three will receive a cochlear implant. They will be followed until they reach the age of five. A group of typically hearing five-year-olds (n=20) and a group of five-year-olds with congenital or early onset SSD who have not received a cochlear implant (n=20) will also be recruited. All three groups of five-year-olds will be tested on measures of hearing in quiet, localizing, and hearing in spatially separated noise for comparison. Scores from the study group and the SSD control group will be compared to evaluate effectiveness.
The study will also explore the potential effects of SSD and early implantation on language, sensory processing, executive function, fatigue, and cognition.
Twenty (20) infants and Toddlers with SSD who are under the age of three will receive a cochlear implant. They will be followed until they reach the age of five. A group of typically hearing five-year-olds (n=20) and a group of five-year-olds with congenital or early onset SSD who have not received a cochlear implant (n=20) will also be recruited. All three groups of five-year-olds will be tested on measures of hearing in quiet, localizing, and hearing in spatially separated noise for comparison. Scores from the study group and the SSD control group will be compared to evaluate effectiveness.
The study will also explore the potential effects of SSD and early implantation on language, sensory processing, executive function, fatigue, and cognition.
Conditions
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Single Sided Deafness
Unilateral Deafness
Hearing Loss, Unilateral
Hearing Loss
Congenital Hearing Loss
Deafness One Ear
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
The study group will receive a cochlear implant under the age of three and be tested at the age of five. Two control groups, both five years old, will be tested as well. The control groups will consist of children with typical hearing in both ears and children with single-sided deafness who have not received a cochlear implant.
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Study Group
This group of children with single-sided deafness will receive a cochlear implant.
Group Type
EXPERIMENTAL
Cochlear Implant
Intervention Type
DEVICE
A cochlear implant is a surgically implanted device that provides access to sound in people cannot get enough access to sound for communication with traditional hearing aids.
Typical Hearing Control Group (THCG)
This group of five-year-old children will have typical hearing in both ears.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Single-Sided Deafness Control Group (SSDCG)
This group of five-year-old children will have single-sided deafness and no cochlear implant.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Cochlear Implant
A cochlear implant is a surgically implanted device that provides access to sound in people cannot get enough access to sound for communication with traditional hearing aids.
Intervention Type
DEVICE
Other Intervention Names
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MED-EL SYNCHRONY 2 Cochlear Implant
Eligibility Criteria
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Inclusion Criteria
1. Provision of signed and dated parental permission form
2. Unilateral severe-to-profound sensorineural hearing loss, congenital or acquired prior to the age of 2 years, defined as:
1. Unaided residual hearing thresholds that yield a 3 frequency pure tone average (PTA; average at 500, 1000, and 2000 Hz) of ≥70 dB hearing loss (HL) in the ear to be implanted
2. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).
i. Thresholds should be measured using inserts wherever possible, or in the sound field to record the better-hearing ear alone. Required thresholds will include 250, 500, 1000, 2000, and 4000 Hz for air conduction. All other octave frequencies should be attempted. Bone conduction thresholds should be obtained at 500, 1000, 2000, and 4000 Hz. Masking should be attempted where appropriate. As participants are very young and masking is difficult for this population, suspected shadow audiograms will be sufficient if objective testing has confirmed a severe-to-profound unilateral hearing loss. Testing should confirm a severe-to-profound hearing loss, defined as a 3-frequency PTA (500, 1000, and 2000) \>70 dB HL in one ear and ≤20 dB HL in the contralateral ear. The Primary Investigator and Lead Diagnostic Audiologist must agree on this diagnosis for enrollment.
3. Insufficient functional access to sound with appropriately fit amplification and aural habilitation (based on best practices and standard of care) defined as:
1. PEACH + parent questionnaire scores below the expected value for children who lack the requisite language to complete open-set word recognition testing or
2. Recorded Multisyllabic Lexical Neighborhood Test (MLNT) scores ≤ 30% in the ear to be implanted for children with the requisite language to complete open-set word recognition testing.
4. Between 7 months and 2 years, 11 months of age at implantation
5. Normal cochlear nerve as evaluated by imaging, required imaging by MRI brain/Internal auditory canal (IAC) without contrast with heavily weighted T2 images. CT optional at the physician's discretion.
6. No malformation of the cochlea
7. No evidence of progressive hearing loss of the contralateral ear
8. Willing to/has undergone hearing aid trial as warranted based on achieving an aided speech intelligibility index (SII) of \> .65 when fitted via Desired Sensation Level (DSL) methods.
9. Realistic parental expectations: a verbal acknowledgment of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing
10. Willing to obtain recommended meningitis vaccinations per Centers for Disease Control (CDC) recommendations
11. Development and cognition within the normal range as measured by the Developmental Assessment of Young Children (DAYC-2).
12. Parental commitment to study parameters including being able and willing to participate in the evaluation schedule, involvement in prescribed therapy, and travel to the investigational site and study-related activities. Parents must be willing to encourage wearing implant during waking hours.
To participate as an SSD control subject, an individual must meet all the following criteria:
1. Provision of signed and dated parental permission form
2. Unilateral severe-to-profound hearing loss - congenital or acquired prior to 2 years of age.
1. Unaided residual hearing thresholds that yield a 3 frequency PTA (500, 1000, and 2000 Hz) of ≥70 dB HL in the affected ear.
2. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz)
3. Unable to use or benefit from traditional amplification
3. Five years of age at the time of testing
4. Development and cognition within the normal range as measured by the Early Stanford Binet 2 (SB2).
To participate as a TH control subject, an individual must meet all the following criteria:
1. Provision of signed and dated parental permission form
2. Bilateral hearing thresholds that yield a PTA of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).
3. Five years of age at the time of testing
4. Development and cognition within the normal range as measured by the Early SB2.
An individual who meets any of the following criteria will be excluded from participation in this study as a study subject:
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. Cochlear nerve deficiency
4. Ossification/Fibrosis of the cochlea precluding implantation
5. Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)
6. History of refractory chronic otitis media or condition that contraindicates anesthesia
An individual who meets any of the following criteria will be excluded from participation in this study as a control subject:
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. Inability to participate in testing (i.e., unwillingness)
2. Unilateral severe-to-profound sensorineural hearing loss, congenital or acquired prior to the age of 2 years, defined as:
1. Unaided residual hearing thresholds that yield a 3 frequency pure tone average (PTA; average at 500, 1000, and 2000 Hz) of ≥70 dB hearing loss (HL) in the ear to be implanted
2. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).
i. Thresholds should be measured using inserts wherever possible, or in the sound field to record the better-hearing ear alone. Required thresholds will include 250, 500, 1000, 2000, and 4000 Hz for air conduction. All other octave frequencies should be attempted. Bone conduction thresholds should be obtained at 500, 1000, 2000, and 4000 Hz. Masking should be attempted where appropriate. As participants are very young and masking is difficult for this population, suspected shadow audiograms will be sufficient if objective testing has confirmed a severe-to-profound unilateral hearing loss. Testing should confirm a severe-to-profound hearing loss, defined as a 3-frequency PTA (500, 1000, and 2000) \>70 dB HL in one ear and ≤20 dB HL in the contralateral ear. The Primary Investigator and Lead Diagnostic Audiologist must agree on this diagnosis for enrollment.
3. Insufficient functional access to sound with appropriately fit amplification and aural habilitation (based on best practices and standard of care) defined as:
1. PEACH + parent questionnaire scores below the expected value for children who lack the requisite language to complete open-set word recognition testing or
2. Recorded Multisyllabic Lexical Neighborhood Test (MLNT) scores ≤ 30% in the ear to be implanted for children with the requisite language to complete open-set word recognition testing.
4. Between 7 months and 2 years, 11 months of age at implantation
5. Normal cochlear nerve as evaluated by imaging, required imaging by MRI brain/Internal auditory canal (IAC) without contrast with heavily weighted T2 images. CT optional at the physician's discretion.
6. No malformation of the cochlea
7. No evidence of progressive hearing loss of the contralateral ear
8. Willing to/has undergone hearing aid trial as warranted based on achieving an aided speech intelligibility index (SII) of \> .65 when fitted via Desired Sensation Level (DSL) methods.
9. Realistic parental expectations: a verbal acknowledgment of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing
10. Willing to obtain recommended meningitis vaccinations per Centers for Disease Control (CDC) recommendations
11. Development and cognition within the normal range as measured by the Developmental Assessment of Young Children (DAYC-2).
12. Parental commitment to study parameters including being able and willing to participate in the evaluation schedule, involvement in prescribed therapy, and travel to the investigational site and study-related activities. Parents must be willing to encourage wearing implant during waking hours.
To participate as an SSD control subject, an individual must meet all the following criteria:
1. Provision of signed and dated parental permission form
2. Unilateral severe-to-profound hearing loss - congenital or acquired prior to 2 years of age.
1. Unaided residual hearing thresholds that yield a 3 frequency PTA (500, 1000, and 2000 Hz) of ≥70 dB HL in the affected ear.
2. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz)
3. Unable to use or benefit from traditional amplification
3. Five years of age at the time of testing
4. Development and cognition within the normal range as measured by the Early Stanford Binet 2 (SB2).
To participate as a TH control subject, an individual must meet all the following criteria:
1. Provision of signed and dated parental permission form
2. Bilateral hearing thresholds that yield a PTA of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).
3. Five years of age at the time of testing
4. Development and cognition within the normal range as measured by the Early SB2.
An individual who meets any of the following criteria will be excluded from participation in this study as a study subject:
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. Cochlear nerve deficiency
4. Ossification/Fibrosis of the cochlea precluding implantation
5. Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)
6. History of refractory chronic otitis media or condition that contraindicates anesthesia
An individual who meets any of the following criteria will be excluded from participation in this study as a control subject:
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. Inability to participate in testing (i.e., unwillingness)
Minimum Eligible Age
7 Months
Maximum Eligible Age
71 Months
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Med-El Corporation
INDUSTRY
Sponsor Role
collaborator
University of North Carolina, Chapel Hill
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Lisa Park, AuD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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The Children's Cochlear Implant Center at UNC
Durham, North Carolina, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Bess FH, Tharpe AM. An introduction to unilateral sensorineural hearing loss in children. Ear Hear. 1986 Feb;7(1):3-13. doi: 10.1097/00003446-198602000-00003.
Reference Type
BACKGROUND
Bess FH, Tharpe AM. Unilateral hearing impairment in children. Pediatrics. 1984 Aug;74(2):206-16.
Reference Type
BACKGROUND
Corbin NE, Buss E, Leibold LJ. Spatial Hearing and Functional Auditory Skills in Children With Unilateral Hearing Loss. J Speech Lang Hear Res. 2021 Nov 8;64(11):4495-4512. doi: 10.1044/2021_JSLHR-20-00081. Epub 2021 Oct 5.
Reference Type
BACKGROUND
Anne S, Lieu JEC, Cohen MS. Speech and Language Consequences of Unilateral Hearing Loss: A Systematic Review. Otolaryngol Head Neck Surg. 2017 Oct;157(4):572-579. doi: 10.1177/0194599817726326. Epub 2017 Aug 22.
Reference Type
BACKGROUND
Lieu JEC. Permanent Unilateral Hearing Loss (UHL) and Childhood Development. Curr Otorhinolaryngol Rep. 2018;6(1):74-81. doi: 10.1007/s40136-018-0185-5. Epub 2018 Feb 15.
Reference Type
BACKGROUND
Purcell PL, Shinn JR, Davis GE, Sie KC. Children with unilateral hearing loss may have lower intelligence quotient scores: A meta-analysis. Laryngoscope. 2016 Mar;126(3):746-54. doi: 10.1002/lary.25524. Epub 2015 Oct 9.
Reference Type
BACKGROUND
Bell R, Mouzourakis M, Wise SR. Impact of unilateral hearing loss in early development. Curr Opin Otolaryngol Head Neck Surg. 2022 Oct 1;30(5):344-350. doi: 10.1097/MOO.0000000000000848. Epub 2022 Aug 24.
Reference Type
BACKGROUND
Russo FY, De Seta D, Orlando MP, Ralli M, Cammeresi MG, Greco A, de Vincentiis M, Ruoppolo G, Mancini P, Turchetta R. Hearing attention and quality of listening in children with unilateral hearing loss with and without hearing aid. Acta Otorhinolaryngol Ital. 2022 Apr;42(2):169-175. doi: 10.14639/0392-100X-N1746.
Reference Type
BACKGROUND
McKay S, Gravel JS, Tharpe AM. Amplification considerations for children with minimal or mild bilateral hearing loss and unilateral hearing loss. Trends Amplif. 2008 Mar;12(1):43-54. doi: 10.1177/1084713807313570.
Reference Type
BACKGROUND
Ead B, Hale S, DeAlwis D, Lieu JE. Pilot study of cognition in children with unilateral hearing loss. Int J Pediatr Otorhinolaryngol. 2013 Nov;77(11):1856-60. doi: 10.1016/j.ijporl.2013.08.028. Epub 2013 Sep 6.
Reference Type
BACKGROUND
Park LR, Griffin AM, Sladen DP, Neumann S, Young NM. American Cochlear Implant Alliance Task Force Guidelines for Clinical Assessment and Management of Cochlear Implantation in Children With Single-Sided Deafness. Ear Hear. 2022 Mar/Apr;43(2):255-267. doi: 10.1097/AUD.0000000000001204.
Reference Type
BACKGROUND
Brown KD, Dillon MT, Park LR. Benefits of Cochlear Implantation in Childhood Unilateral Hearing Loss (CUHL Trial). Laryngoscope. 2022 Mar;132 Suppl 6(Suppl 6):S1-S18. doi: 10.1002/lary.29853. Epub 2021 Sep 20.
Reference Type
BACKGROUND
Park LR, Dillon MT, Buss E, O'Connell BP, Brown KD. Spatial Release From Masking in Pediatric Cochlear Implant Recipients With Single-Sided Deafness. Am J Audiol. 2021 Jun 14;30(2):443-451. doi: 10.1044/2020_AJA-20-00119. Epub 2021 Mar 26.
Reference Type
BACKGROUND
Park LR, Preston E, Noxon AS, Dillon MT. Comparison of test methods to assess the implanted ear alone for pediatric cochlear implant recipients with single-sided deafness. Cochlear Implants Int. 2021 Sep;22(5):283-290. doi: 10.1080/14670100.2021.1903715. Epub 2021 Mar 24.
Reference Type
BACKGROUND
Nassrallah F, Tang K, Whittingham J, Sun H, Fitzpatrick EM. Auditory, Social, and Behavioral Skills of Children With Unilateral/Mild Hearing Loss. J Deaf Stud Deaf Educ. 2020 Apr 5;25(2):167-177. doi: 10.1093/deafed/enz041.
Reference Type
BACKGROUND
Bess FH, Davis H, Camarata S, Hornsby BWY. Listening-Related Fatigue in Children With Unilateral Hearing Loss. Lang Speech Hear Serv Sch. 2020 Jan 8;51(1):84-97. doi: 10.1044/2019_LSHSS-OCHL-19-0017. Epub 2020 Jan 8.
Reference Type
BACKGROUND
Hoff S, Ryan M, Thomas D, Tournis E, Kenny H, Hajduk J, Young NM. Safety and Effectiveness of Cochlear Implantation of Young Children, Including Those With Complicating Conditions. Otol Neurotol. 2019 Apr;40(4):454-463. doi: 10.1097/MAO.0000000000002156.
Reference Type
BACKGROUND
Deep NL, Purcell PL, Gordon KA, Papsin BC, Roland JT Jr, Waltzman SB. Cochlear Implantation in Infants: Evidence of Safety. Trends Hear. 2021 Jan-Dec;25:23312165211014695. doi: 10.1177/23312165211014695.
Reference Type
BACKGROUND
Chweya CM, May MM, DeJong MD, Baas BS, Lohse CM, Driscoll CLW, Carlson ML. Language and Audiological Outcomes Among Infants Implanted Before 9 and 12 Months of Age Versus Older Children: A Continuum of Benefit Associated With Cochlear Implantation at Successively Younger Ages. Otol Neurotol. 2021 Jun 1;42(5):686-693. doi: 10.1097/MAO.0000000000003011.
Reference Type
BACKGROUND
Benchetrit L, Ronner EA, Anne S, Cohen MS. Cochlear Implantation in Children With Single-Sided Deafness: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2021 Jan 1;147(1):58-69. doi: 10.1001/jamaoto.2020.3852.
Reference Type
BACKGROUND
Other Identifiers
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22-0862
Identifier Type: -
Identifier Source: org_study_id
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