Clinical trial NCT04793412: Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial
Official title: Cochlear Implantation in Children With Asymmetric Hearing Loss or Single-Sided Deafness Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asymmetric Hearing Loss
Single-sided Deafness
Unilateral Deafness
Keywords: hearing loss
cochlear implant
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: St. Louis Children's Hospital
name: University of Southern California
name: Children's Hospital of Philadelphia
name: Hearts for Hearing
name: University of Minnesota
First posted: 2021-03-11
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Poor ear alone word recognition in quiet from Pre-Implant to 12 months post-implant
timeFrame: Pre-Implant and 12 months post-implant
measure: Change in Bimodal speech understanding in noise from Pre-Implant to 15 months post-implant
timeFrame: Pre-implant and 15 months post-implant
measure: Post-implant bimodal vs better ear alone speech understanding in noise
timeFrame: 15 months post-implant
measure: Change in pre-implant trajectory of Bimodal speech understanding in noise over time to post-implant trajectory over time
timeFrame: 5 visits pre-implant over a minimum of 4 months and the 3, 6, 9, 12, and 15 month post-implant visits
Secondary outcomes:
measure: Change in Poor ear alone audibility from Pre-Implant to 12 months post-implant
timeFrame: Pre-implant and 12 months post-implant
measure: Change in Bimodal sound localization from Pre-Implant to 15 months post-implant
timeFrame: Pre-implant and 15 months post-implant
measure: Change in Bimodal soft speech understanding from Pre-Implant to 12 months post-implant
timeFrame: Pre-implant and 12 months post-implant
measure: Change in PedsQL-MFS ratings from Pre-Implant to 15 months post-implant
timeFrame: Pre-implant and 15 months post-implant
measure: Change in SSQ ratings from Pre-Implant to 15 months post-implant
timeFrame: Pre-implant and 15 months post-implant
measure: Change in HEAR-QL ratings from Pre-Implant to 15 months post-implant
timeFrame: Pre-implant and 15 months post-implant
measure: Post-implant bimodal vs better ear alone sound localization
timeFrame: 15 months post-implant
measure: Post-implant bimodal vs better ear alone soft speech understanding
timeFrame: 12 months post-implant
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck School of Medicine of the University of Southern California
state: California
city: Minneapolis
country: United States
facility: Fairview Health Services
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine/St Louis Children's Hospital
state: Missouri
city: Oklahoma City
country: United States
facility: Hearts for Hearing
state: Oklahoma
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia - Buerger Center
state: Pennsylvania
Study officials:
affiliation: Washington University School of Medicine in St Louis
name: Jill B Firszt, PhD
role: PRINCIPAL_INVESTIGATOR
References: