High Frequency Sensorineural Hearing ImpairmentNCT03379870

Outcomes in Children With Pre-operative Residual Hearing

A study testing Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting and Electric Acoustic Speech Processor: Full-electric stimulation fitting in people with High Frequency Sensorineural Hearing Impairment and Hearing Disorders in Children, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Purpose: Routine clinical care and pilot study data has shown evidence of postoperative hearing preservation in pediatric cochlear implant (CI) recipients. The primary aim of this study is to investigate speech perception performance in pediatric CI recipients with functional pre-operative hearing. Read more about this study

Who is it for?: Ages 60 to 215 monthsHealthy volunteers can take part
Conditions the study is for: High Frequency Sensorineural Hearing Impairment, Hearing Disorders in Children
What is being tested?: Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting and Electric Acoustic Speech Processor: Full-electric stimulation fitting
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 25 May 2018to 14 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 to 215 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged 5 through 17 years
Spoken English as the primary language (speech perception testing conducted in English).
Recipient of a MED-EL SYNCHRONY Cochlear Implant device.
Pre-operative LFPTA of ≤ 75 dB HL.
Willing and able to participate in study procedures.
Realistic parental/patient expectations.
Language skills judged to be adequate enough to perform study tasks.

Who cannot join

Inability to perform open set speech perception due to oral motor delays.
Inability to perform test battery due to behavior or cognitive impairment
Unwilling or unable to participate in study procedures.
Cochlear nerve deficiency.
Anatomical considerations that necessitated surgical modifications such as ossification, incomplete insertion, or placement in scala vestibuli.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Children's Cochlear Implant Center at UNC
Durham, North Carolina, 27713-6102

Other trials in United States

About this study

Official title: Outcomes in Children With Cochlear Implants and Pre-Operative Residual Hearing: Electric Only and Electric-Acoustic Stimulation

Participants: Two cohorts of CI recipients aged 6 through 17 years who had pre-operative low frequency residual hearing. Subjects in Arm 1 (EAS Arm; electric-acoustic stimulation) will present with a post-operative low frequency pure tone average (125, 250, and 500 Hz) of ≤ 75 dB HL, and those in Arm 2 (FES Arm; full-electric stimulation) will present with a post-operative low frequency pure tone average (LFPTA) that exceeds 75 dB HL.

Procedures (methods): Subjects will complete speech perception and quality of life testing during post-operative intervals. Subjects in the EAS Arm will be evaluated with combined electric-acoustic stimulation (EAS). Subjects in FES Arm will be evaluated with FES alone.

Read the detailed description

As children with more residual hearing are receiving cochlear implants (CIs), there is an opportunity to preserve that hearing and provide combined electric and acoustic stimulation (EAS). The primary aim of this study is to investigate speech perception performance in pediatric CI recipients with functional pre-operative hearing. Specifically, the investigators intend to compare speech understanding using EAS and traditional full electric stimulation.

While hearing preservation rates are good, they are not guaranteed. Children with progressive hearing loss may continue to lose hearing, even if they maintain some residual hearing immediately after surgery. As a secondary aim, the investigators intend to study outcomes in children who do not maintain residual hearing and are fit with traditional CI programming methods. Children with more residual hearing are being implanted, and this study design allows validation of outcomes in both populations.

Subject enrollment will occur on the initial stimulation date. Those who have maintained a low frequency hearing average of 75 dB HL or better will be fit with a SONNET EAS or SONNET 2 EAS device using combined acoustic and electric stimulation. Those who have not maintained low frequency hearing will be fit with a SONNET EAS or SONNET 2 EAS device using electric stimulation only. Subjects will be followed at regular intervals throughout the year duration of the study and will be tested on measures of speech understanding in quiet, speech understanding in noise, quality of life, and discrimination of prosody or pitch changes.

Conditions: High Frequency Sensorineural Hearing Impairment, Hearing Disorders in Children
Being tested: Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting, Electric Acoustic Speech Processor: Full-electric stimulation fitting
Keywords: cochlear implant, electric acoustic stimulation, EAS, hearing loss, pediatric
Medical subject headings: Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Electric Acoustic Speech Processor: Electric-acoustic stimulation fittingDevice
Also called MED-EL SONNET EAS, MED-EL SONNET 2 EAS
Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,
Electric Acoustic Speech Processor: Full-electric stimulation fittingDevice
Also called MED-EL SONNET EAS, MED-EL SONNET 2 EAS
Electric Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or poorer and pre-operative low frequency hearing averages of 75 dB HL or better.

Study groups in NCT03379870
Study group	Role	What they receive
EAS Arm	Experimental	Subjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: Electric-acoustic stimulation (EAS) fitting. Receives: Device: Electric Acoustic Speech Processor: Electric-acoustic stimulation fitting
FES Arm	Experimental	Subjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of > 75 dB HL. Electric Acoustic Speech Processor: Full-electric stimulation (FES) fitting Receives: Device: Electric Acoustic Speech Processor: Full-electric stimulation fitting

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean CNC Word Scores
The Consonant Nucleus Consonant (CNC) word list is established as a standard test of speech perception outcomes. Results for EAS and FES Arms at 12 months post stimulation will be compared. Lower scores indicate a poorer outcome and higher scores a better outcome. Scale 0 - 100%
Measured: 12 months post stimulation
Mean BKB-SIN SNR-50 Scores
Sentences and babble will be presented from the same speaker. An average score known as the SNR-50 will be obtained in both conditions. The SNR-50 score is an estimate of the signal-to-noise ratio associated with 50% correct based on word-level scoring. Results for EAS and FES listeners at 12 months post stimulation will be compared. In this test, lower scores indicate a better outcome and higher scores a poorer outcome. Scores range from -6 dB to +21 dB.
Measured: 12 months post-stimulation

Secondary outcomes (4)

Mean Pediatric SSQ Scores
The Speech, Spatial, and Qualities of Hearing (SSQ) Scale assesses performance in three domains, hearing speech in quiet and noise environments (9 items), spatial or directional hearing (5 items) and sound qualities (8 items), which address sound segregation and listening effort. Each item is rated on a 11-point scale, with 0 as the lowest possible performance and 10 as the highest. Domain scores represent an average of item ratings. There is a version for children that will be used for this study. Lower scores indicate a poorer outcome, and higher scores a better outcome.
Measured: Baseline, 12 months post-stimulation
Receptive Language Scores
Mean receptive language scores as measured by the Oral and Written Language Scales, 2nd edition (OWLS II), comparing pre-operative scores to the 12 month test point for both groups. These tests are normed and reported as scaled scores. T-Scores scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome. A scores of 100 indicated the population mean with a standard deviation of 15. A score of 85 or poorer is indicative of a receptive language delay.
Measured: 12 months post-stimulation
Articulation Scores
Mean articulation scores as measured by the Goldman-Fristoe Test of Articulation, 3rd edition (GFTA3), comparing pre-operative scores to the 12 month test point for both groups. These tests are normed and reported as scaled scores. T-Scores scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome. A score of 100 indicates the population mean with a standard deviation of 15. A score of 85 or poorer is indicative of a articulation delay.
Measured: 12 months post-stimulation
Expressive Language Scores
Mean expressive language scores as measured by the Oral and Written Language Scales, 2nd edition (OWLS II), comparing pre-operative scores to the 12 month test point for both groups. These tests are normed and reported as scaled scores. T-Scores scores will be compared. Low scores are indicative of a poorer outcome, and higher scores a better outcome. A score of 100 indicates the population mean with a standard deviation of 15. A score of 85 or poorer is indicative of an expressive language delay.
Measured: 12 months post-stimulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 May 201814 Dec 2023

First posted20 Dec 2017
Study start25 May 2018
Primary completion14 Dec 2023
Study completion14 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for High Frequency Sensorineural Hearing ImpairmentStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03379870
Sponsor's protocol ID: 17-2360
Status last verified: May 2024
First submitted: 15 Dec 2017
Last updated: 15 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Outcomes in Children With Cochlear Implants and Pre-Operative Residual Hearing: Electric Only and Electric-Acoustic Stimulation
ClinicalTrials.gov ID: NCT03379870
Acronym / sponsor ID: 17-2360
Conditions: High Frequency Sensorineural Hearing Impairment, Hearing Disorders in Children
Keywords: cochlear implant, electric acoustic stimulation, EAS, hearing loss, pediatric
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: Med-El Corporation
Study start: 25 May 2018 (actual)
Primary completion: 14 Dec 2023 (actual)
Study completion: 14 Dec 2023 (actual)
First posted: 20 Dec 2017 (actual)
Results: Posted 15 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
EAS Arm	Experimental	Device: Electric Acoustic Speech Processor: Electric-acoustic stimulation fittingSubjects who receive a CI and present with a post-operative LFPTA of ≤ 75 dB HL. Electric Acoustic Speech Processor: Electric-acoustic stimulation (EAS) fitting.
FES Arm	Experimental	Device: Electric Acoustic Speech Processor: Full-electric stimulation fittingSubjects with pre-operative low frequency hearing who receive a CI and present with a post-operative LFPTA of > 75 dB HL. Electric Acoustic Speech Processor: Full-electric stimulation (FES) fitting

Who may qualify

Ages: 60 to 215 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

Aged 5 through 17 years
Spoken English as the primary language (speech perception testing conducted in English).
Recipient of a MED-EL SYNCHRONY Cochlear Implant device.
Pre-operative LFPTA of ≤ 75 dB HL.
Willing and able to participate in study procedures.

Key exclusion criteria (5 listed)

Inability to perform open set speech perception due to oral motor delays.
Inability to perform test battery due to behavior or cognitive impairment
Unwilling or unable to participate in study procedures.
Cochlear nerve deficiency.
Anatomical considerations that necessitated surgical modifications such as ossification, incomplete insertion, or placement in scala vestibuli.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Electric Acoustic Speech Processor: Electric-acoustic stimulation fittingAlso: MED-EL SONNET EAS, MED-EL SONNET 2 EASElectric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,	Device	EAS Arm
Electric Acoustic Speech Processor: Full-electric stimulation fittingAlso: MED-EL SONNET EAS, MED-EL SONNET 2 EASElectric Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or poorer and pre-operative low frequency hearing averages of 75 dB HL or better.	Device	FES Arm

Primary outcome

Mean CNC Word Scores
Time frame: 12 months post stimulation
The Consonant Nucleus Consonant (CNC) word list is established as a standard test of speech perception outcomes. Results for EAS and FES Arms at 12 months post stimulation will be compared. Lower scores indicate a poorer outcome and higher scores a better outcome. Scale 0 - 100%
Mean BKB-SIN SNR-50 Scores
Time frame: 12 months post-stimulation
Sentences and babble will be presented from the same speaker. An average score known as the SNR-50 will be obtained in both conditions. The SNR-50 score is an estimate of the signal-to-noise ratio associated with 50% correct based on word-level scoring. Results for EAS and FES listeners at 12 months post stimulation will be compared. In this test, lower scores indicate a better outcome and higher scores a poorer outcome. Scores range from -6 dB to +21 dB.

4 secondary outcomes

Mean Pediatric SSQ Scores
Time frame: Baseline, 12 months post-stimulation
Receptive Language Scores
Time frame: 12 months post-stimulation
Articulation Scores
Time frame: 12 months post-stimulation
Expressive Language Scores
Time frame: 12 months post-stimulation

Results and safety

Results posted to the registry on 15 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EAS Arm	16	14
FES Arm	12	11

Primary outcome: Mean CNC Word Scores

Time frame: 12 months post stimulation. Mean (Standard Deviation). Unit: Percent Correct

Measure	EAS Arm n = 14	FES Arm n = 11
Value	71.0 (18.0)	68.4 (26.0)

EAS Arm vs FES Arm: p = .768, Mixed Models Analysis

Population analysed: Subjects who completed the 12-month protocol

Primary outcome: Mean BKB-SIN SNR-50 Scores

Time frame: 12 months post-stimulation. Mean (Standard Deviation). Unit: Signal to noise ratio (SNR) in decibels

Measure	EAS Arm n = 14	FES Arm n = 11
Value	6.9 (9.3)	5.5 (7.7)

EAS Arm vs FES Arm: p = .529, Mixed Models Analysis

Population analysed: Subjects who completed the 12-month protocol

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of signing informed consent through 12 months post-activation.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EAS Arm	0 of 16 (0%)	1 of 16 (6.3%)	0 of 16
FES Arm	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lisa Park, AuD principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean CNC Word Scores (time frame: 12 months post stimulation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03379870.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.