Optimizing Soft Speech Recognition in Children With Hearing Loss (SoftSpeech)
Primary Purpose
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hearing Aid
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss, Sensorineural
Eligibility Criteria
Inclusion Criteria:
- native English speakers who communicate verbally
- no known speech language disorders, cognitive or learning issues
- experienced hearing aid users (> 6 months use)
- "full-time" hearing aid users (i.e., wear on a daily basis)
- CNC word scores of 30% or better at 50dBA in quiet with SE "off"
Exclusion Criteria:
- new hearing aid users
- inconsistent hearing aid users
- <4 years or >12 years of age
- non-native English speaker who communicates verbally
- known cognitive/ learning issues or speech language disorder
- CNC word scores < 30% correct presented at 50dBA in quiet with SE "off"
Sites / Locations
- Hearts for Hearing
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Children with Hearing Loss
Arm Description
Behavioral and subjective preference data will be collected in children with hearing loss who are unaided (no technology) or aided with Phonak Audeo P or Naida P hearing aids with Speech Enhancer on at moderate, on at strong, or off.
Outcomes
Primary Outcome Measures
Speech Enhancer effect on Speech Recognition
Difference in aided speech recognition accuracy, percent correct CNC word scores, in 44 participants listening with Speech Enhancer "on" at the moderate setting compared to Speech Enhancer "off".
Secondary Outcome Measures
Speech Enhancer Age/ Strength Effect
Difference in aided speech recognition accuracy scores, percent correct CNC word scores, between 22 younger (4-8 year old) and 22 older (9-12 year old) children listening with Speech Enhancer activated at "moderate" and "strong settings.
Hearing Aid Intended Use
Difference in soft speech recognition scores, measured as percent correct CNC word scores, in 44 patients with hearing loss listening unaided compared to aided with Phonak Audeo P or Naida P devices.
Full Information
NCT ID
NCT05299892
First Posted
March 1, 2022
Last Updated
October 21, 2022
Sponsor
Sonova AG
Collaborators
Hearts for Hearing
1. Study Identification
Unique Protocol Identification Number
NCT05299892
Brief Title
Optimizing Soft Speech Recognition in Children With Hearing Loss
Acronym
SoftSpeech
Official Title
Optimizing Soft Speech Recognition in Children With Hearing Loss
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
October 14, 2022 (Actual)
Study Completion Date
October 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
Hearts for Hearing
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Overhearing is important for vocabulary learning and speech and language development in young children. However, contemporary hearing aids are generally unable provide adequate access to low-level auditory inputs from multiple talkers at a distance to capitalize on overhearing. A recent investigation by Jace Wolfe and colleagues showed that, even when aided, children with hearing loss had significantly poorer speech recognition at 40, 50 and 60 dBA compared to children with normal hearing. Furthermore, they showed that increasing hearing aid gain for very low-level inputs produced a statistically significant improvement in syllable-final plural recognition and a non-significant trend toward better monosyllabic word recognition at very low presentation levels. Additional research is needed to document low-level speech recognition ability of children with hearing loss as well as the potential benefit or detriment of increasing hearing aid gain for low-level inputs. A novel hearing aid technology known as Soft Speech Enhancer has been shown improve low-level speech perception in adults with hearing loss; however, the effect of Speech Enhancer on speech recognition in children is not yet known and will be evaluated.
Detailed Description
The primary objective of this study is to evaluate whether soft speech recognition in quiet is significantly improved with Speech Enhancer (SE) "on" at the default setting (moderate) compared to Speech Enhancer "off" in children with moderate (N3) to severe (N5) hearing loss. There are several secondary objectives: 1) To evaluate the main effects of age and Speech Enhancer strength, and potential interaction on speech recognition and comfort in children with moderate to severe hearing loss. 2) To confirm no negative effect of speech enhancer "on" at the default setting on low-level speech recognition in noise. 3) To demonstrate that hearing aids compensate for hearing loss in children.
This confirmatory clinical investigation will be executed at Hearts for Hearing. It is a single-group, single blind intervention study with each participant serving as his or her own control. However, in certain conditions participant blinding is not feasible (i.e., aided versus unaided performance). The outcome measures being assessed include: speech recognition in quiet and noise with CNC words, speech detection in quiet with the UWO Plurals test, comfort ratings using a Multiple Stimuli with Hidden Reference and Anchor (MUSHRA) procedure and looped sentences overlaid with low-level transient noise.
Four different hearing aid conditions will be assessed in this clinical investigation: unaided (no amplification), aided with SE "off", aided with SE "moderate", aided with SE "strong". For the unaided or no treatment condition no hearing aids will be worn. For aided conditions, experienced hearing aid users will be fit binaurally with investigational devices matching their personal device form factor connected to their personal acoustic coupling (e.g., earmold). Using the Audioscan Verifit 2, probe microphone measurements will be conducted to match DSL 5.0 pediatric quiet and noise targets. Three distinct programs will be created, each with a different SE strength.
Hearing aid program order (speech enhancer settings) will be randomized for all testing conditions except for CNC at 50 dBA Quiet with SE Off; that condition is administered first to establish candidacy for further testing. A randomized list of SE settings was generated for all participants for the remaining conditions.
Testing will be completed in a double-walled sound booth with calibrated equipment. Recorded stimuli will be presented through loudspeakers (Sony CFD-ZW755) from clinical audiometers (Grayson Stadler Standard) or Dell computers using the Arizona State University Speech Recognition Program, Windows Media Player and Adobe Audition. Speech stimuli will be presented from a loudspeaker located at 0 degrees azimuth (directly in front) and noise will be generated from a single loudspeaker located at 180 degrees azimuth (directly behind) the patient.
Speech recognition results will be compared to determine the effect of amplification on accuracy scores as well as the influence of speech enhancer on behaviorally measured benefit and subjectively-derived listening preference.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One group of participants will be assessed unaided and aided with Phonak Audeo P or Phonak Naida P hearing aids with Speech Enhancer "off", "on at moderate", and "on at strong" settings.
Masking
None (Open Label)
Masking Description
Participants will be "blind" as to whether the Speech Enhancer feature is activated or deactivated.
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Children with Hearing Loss
Arm Type
Experimental
Arm Description
Behavioral and subjective preference data will be collected in children with hearing loss who are unaided (no technology) or aided with Phonak Audeo P or Naida P hearing aids with Speech Enhancer on at moderate, on at strong, or off.
Intervention Type
Device
Intervention Name(s)
Hearing Aid
Intervention Description
Phonak Audeo P or Naida P hearing aid with or without speech enhancer.
Primary Outcome Measure Information:
Title
Speech Enhancer effect on Speech Recognition
Description
Difference in aided speech recognition accuracy, percent correct CNC word scores, in 44 participants listening with Speech Enhancer "on" at the moderate setting compared to Speech Enhancer "off".
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Speech Enhancer Age/ Strength Effect
Description
Difference in aided speech recognition accuracy scores, percent correct CNC word scores, between 22 younger (4-8 year old) and 22 older (9-12 year old) children listening with Speech Enhancer activated at "moderate" and "strong settings.
Time Frame
5 months
Title
Hearing Aid Intended Use
Description
Difference in soft speech recognition scores, measured as percent correct CNC word scores, in 44 patients with hearing loss listening unaided compared to aided with Phonak Audeo P or Naida P devices.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
native English speakers who communicate verbally
no known speech language disorders, cognitive or learning issues
experienced hearing aid users (> 6 months use)
"full-time" hearing aid users (i.e., wear on a daily basis)
CNC word scores of 30% or better at 50dBA in quiet with SE "off"
Exclusion Criteria:
new hearing aid users
inconsistent hearing aid users
<4 years or >12 years of age
non-native English speaker who communicates verbally
known cognitive/ learning issues or speech language disorder
CNC word scores < 30% correct presented at 50dBA in quiet with SE "off"
Facility Information:
Facility Name
Hearts for Hearing
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
12. IPD Sharing Statement
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Optimizing Soft Speech Recognition in Children With Hearing Loss
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