Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial

Study Overview
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Brief Summary
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This is a two-phase study that compares performance growth pre-implant with current hearing aid (HA) technology versus post-implant with a cochlear implant (CI) in children with either asymmetric hearing loss (AHL) or single-sided deafness (SSD). Post-implant performance with a CI alone is expected to outperform pre-implant performance with a HA. The study also evaluates the effectiveness of bimodal hearing defined as a CI in the poor ear and a HA in the better ear for AHL or a CI in the poor ear and normal hearing in the better ear for SSD compared to pre-implant performance. The study examines factors contributing to CI outcomes.

Detailed Description
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The study is conducted as a multicenter, prospective, two-phase clinical trial, evaluating the efficacy and safety of cochlear implantation in children with asymmetric hearing loss (AHL) or single-sided deafness (SSD). A hearing aid (HA) phase occurs over a minimum of 4 mos prior to obtaining a cochlear implant (CI). A CI phase occurs over the 15-month period after initial activation of the CI. The AHL/SSD groups are tested for change in performance pre- to post-implant. Investigators also collect longitudinal data over 12 months (matching the 3 to 15 month post-implant timeframe) from normal hearing (NH) participants to provide additional information about outcome trajectory due to development alone. The NH participants are matched to AHL/SSD participants on age, gender and parent education. Post-implant performance with a CI alone is expected to outperform pre-implant performance with a HA. The study evaluates the effectiveness of bimodal hearing defined as a CI in the poor ear and a HA in the better ear for AHL or a CI in the poor ear and normal hearing in the better ear for SSD compared to pre-implant performance. The study examines factors contributing to CI outcomes.

Official Title
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Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial

Conditions
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Asymmetric Hearing Loss, Single-sided Deafness, Unilateral Deafness

Intervention / Treatment
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* Device: Cochlear Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 4 ys of age and up to 14 yrs, 11 mos of age and able to complete all investigational procedures. Parents and child fluent in English. Parents desire bilateral hearing for their child, are willing to comply with study requirements, including the pre-implant HA phase, and are able to provide informed consent. Poor ear (AHL/SSD): PTA at .5, 1, 2 kHz > 70 dB HL; Aided CNC word recognition score at 60 dB SPL < 40%; SPHL duration ≥ 6 mos and ≤ 10 yrs at time of CI surgery; If > 5 yrs of age, evidence of non-congenital SPHL onset (e.g., passed newborn hearing screening); If ≤ 5 yrs of age, no restrictions on SPHL onset. Better ear AHL: PTA at .5, 1, 2, 4 kHz > 25 and ≤ 60 dB HL; Aided CNC word score at 60 dB SPL ≥ 55%; Currently using a HA; Stable hearing for the past 6-mo period. Stable is defined as thresholds that have not declined by more than 20 dB at three or more octave-interval audiometric frequencies. SSD: PTA at .5, 1, 2, 4 kHz ≤ 25 dB HL; CNC word score at 60 dB SPL ≥ 70%; Stable hearing for the past 6-mo period. Both ears of NH participants: PTA at .5, 1, 2, 4 kHz ≤ 25 dB HL. To continue with cochlear implantation and into the CI phase of the study: Indication, via imaging, of a normal cochlear nerve and of cochlear anatomy in the ear to be implanted that allows full insertion of the electrode array. Imaging modality is at the discretion of the surgeon. In addition, better ear hearing must be stable throughout the HA phase. Exclusion Criteria for AHL/SSD Participants: Medical condition that contraindicates surgery; Actively using an implantable device in the ear to be implanted; Inability to complete study procedures; Unrealistic expectations related to the benefits and limitations of implantation; Unwillingness or inability to comply with all investigational requirements. Exclusions for cochlear implantation and the CI phase of the study: Cochlear malformation or obstruction that would preclude full insertion of the electrode array in the ear to be implanted; Abnormal cochlear nerve in the ear to be implanted; Hearing loss of neural or central origin.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The study is conducted as a multicenter, prospective, two-phase clinical trial, evaluating the efficacy and safety of cochlear implantation in children with asymmetric hearing loss (AHL) or single-sided deafness (SSD). A hearing aid (HA) phase occurs over a minimum of 4 mos prior to obtaining a cochlear implant (CI). A CI phase occurs over the 15-month period after initial activation of the CI.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AHL/SSD<br>Children with asymmetric hearing loss or single-sided deafness | Device: Cochlear Implant<br>* Cochlear implantation of a device from one of the three manufacturers available in the US.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Poor ear alone word recognition in quiet from Pre-Implant to 12 months post-implant | Poor ear alone CNC monosyllabic word recognition in quiet with the CI alone compared to pre-implant with a HA. | Pre-Implant and 12 months post-implant | 
| Change in Bimodal speech understanding in noise from Pre-Implant to 15 months post-implant | Speech reception thresholds (SRTs) for understanding words in noise in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) post-implant compared to the pre-implant best aided condition. | Pre-implant and 15 months post-implant | 
| Post-implant bimodal vs better ear alone speech understanding in noise | Post-implant speech reception thresholds (SRTs) for understanding words in noise in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) compared to the better ear alone condition. | 15 months post-implant | 
| Change in pre-implant trajectory of Bimodal speech understanding in noise over time to post-implant trajectory over time | The trajectory of speech reception thresholds (SRT) for understanding noise throughout the CI Phase (5 visits post-implant) in the bimodal condition is compared to the trajectory throughout the HA Phase (5 visits pre-implant) in the best aided condition. | 5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Poor ear alone audibility from Pre-Implant to 12 months post-implant | FM tone sound field threshold levels in the poor ear alone with a CI compared to pre-implant threshold levels with a HA | Pre-implant and 12 months post-implant | 
| Change in Bimodal sound localization from Pre-Implant to 15 months post-implant | RMS error scores for a sound localization task in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) post-implant compared to the pre-implant best aided condition. | Pre-implant and 15 months post-implant | 
| Change in Bimodal soft speech understanding from Pre-Implant to 12 months post-implant | CNC monosyllabic word recognition at a soft level in the bimodal condition (CI + HA for AHL; CI + NH ear for SSD) post-implant compared to the pre-implant best aided condition. | Pre-implant and 12 months post-implant | 
| Change in PedsQL-MFS ratings from Pre-Implant to 15 months post-implant | Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings. | Pre-implant and 15 months post-implant | 
| Change in SSQ ratings from Pre-Implant to 15 months post-implant | Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings. | Pre-implant and 15 months post-implant | 
| Change in HEAR-QL ratings from Pre-Implant to 15 months post-implant | Questionnaire completed by parents and participants (when age appropriate). Ratings post-implant are compared to pre-implant ratings. | Pre-implant and 15 months post-implant | 
| Post-implant bimodal vs better ear alone sound localization | Post-implant RMS error scores for the sound localization task are compared in the bimodal condition to the better ear alone condition. | 15 months post-implant | 
| Post-implant bimodal vs better ear alone soft speech understanding | Post-implant word recognition scores at soft levels are compared in the bimodal condition to the better ear alone condition. | 12 months post-implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hearing loss, cochlear implant