Hearing Loss, SensorineuralNCT05244603
Application of Ideal Binary Masking to Disordered Speech
A study testing Ideal binary mask in people with Hearing Loss, Sensorineural and Dysarthria, run by Utah State University at 1 site in United States.
Trial summary
Dysarthria and hearing loss are communication disorders that can substantially reduce intelligibility of speech and the addition of background noise adds a further challenge. This proposal utilizes an established signal processing technique, currently exploited for improved understanding of speech in noise for… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural, Dysarthria
- What is being tested?
- Ideal binary mask
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 30 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Native speakers of American English
- No history of speech or language impairment
- No significant prior contact with persons having neurogenic speech disorders
- 18 to 70 years of age
- Auditory thresholds of 20 dB HL or better bilaterally at octave frequencies from 250-8000 Hz (if under 55 years of age)
- Auditory thresholds of 25 dB HL or better bilaterally at octave frequencies from 250-4000 Hz (if over 55 years of age)
- INCLUSION CRITERIA for Participants with Sensorineural Hearing Loss
- 18 to 90 years of age
Who cannot join
- Mild or profound hearing loss
- Conductive or mixed hearing loss
- Asymmetric hearing loss
- Obvious concomitant cognitive or mental impairment
- Unable to achieve upward of 20% words correct
Trial locations and contacts
1 site in 1 country.
About this study
Dysarthria and hearing loss are communication disorders that can substantially reduce intelligibility of speech and the addition of background noise adds a further challenge. This proposal utilizes an established signal processing technique, currently exploited for improved understanding of speech in noise for listeners with hearing loss, to investigate its potential application to overcome speech-in-noise difficulties for listeners understanding dysarthric speech. Successful completion of this project will demonstrate proof-of-concept for the application of this signal processing technique to dysarthric speech in noise, and inform the development of an R01 proposal to perform a large-scale evaluation of the technology, and clinically meaningful implications, in a broad range of disordered speech types and severities.
- Conditions
- Hearing Loss, Sensorineural, Dysarthria
- Being tested
- Ideal binary mask
- Medical subject headings
- Hearing Loss, Sensorineural, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ideal binary maskBehavioural
Speech in noise processed by ideal binary mask to reduce background noise
| Study group | Role | What they receive |
|---|---|---|
| Normal Hearing | Experimental | Listeners with normal hearing Receives: Behavioral: Ideal binary mask |
| Hearing Impaired | Experimental | Listeners with hearing loss Receives: Behavioral: Ideal binary mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Correct Speech Intelligibility
Percent of keywords correctly identified by the participant for the processed speech stimuli, listeners were presented with phrases containing several words and they reported back what they heard. The number of words corrected reported by each listener was counted and converted to a 'percent correct' score.
Measured: One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Dec 2021
- Primary completion1 Dec 2023
- Study completion30 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Leopold, Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244603
- Sponsor's protocol ID
- 10710
- Status last verified
- Mar 2025
- First submitted
- 4 Feb 2022
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borrie SA, Yoho SE, Healy EW, Barrett TS. The Application of Time-Frequency Masking To Improve Intelligibility of Dysarthric Speech in Background Noise. J Speech Lang Hear Res. 2023 May 9;66(5):1853-1866. doi: 10.1044/2023_JSLHR-22-00558. Epub 2023 Mar 21.
PubMed 36944186
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Ideal Binary Masking to Disordered Speech
- ClinicalTrials.gov ID
- NCT05244603
- Acronym / sponsor ID
- 10710
- Conditions
- Hearing Loss, Sensorineural, Dysarthria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Posted 26 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dysarthria and hearing loss are communication disorders that can substantially reduce intelligibility of speech and the addition of background noise adds a further challenge. This proposal utilizes an established signal processing technique, currently exploited for improved understanding of speech in noise for listeners with hearing loss, to investigate its potential application to overcome speech-in-noise difficulties for listeners understanding dysarthric speech. Successful completion of this project will demonstrate proof-of-concept for the application of this signal processing technique to dysarthric speech in noise, and inform the development of an R01 proposal to perform a large-scale evaluation of the technology, and clinically meaningful implications, in a broad range of disordered speech types and severities.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Hearing | Experimental | Behavioral: Ideal binary maskListeners with normal hearing |
| Hearing Impaired | Experimental | Behavioral: Ideal binary maskListeners with hearing loss |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Native speakers of American English
- No history of speech or language impairment
- No significant prior contact with persons having neurogenic speech disorders
- 18 to 70 years of age
- Auditory thresholds of 20 dB HL or better bilaterally at octave frequencies from 250-8000 Hz (if under 55 years of age)
Key exclusion criteria (5 listed)
- Mild or profound hearing loss
- Conductive or mixed hearing loss
- Asymmetric hearing loss
- Obvious concomitant cognitive or mental impairment
- Unable to achieve upward of 20% words correct
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 |
|---|---|---|
| Ideal binary maskSpeech in noise processed by ideal binary mask to reduce background noise | Behavioural | Hearing Impaired, Normal Hearing |
Primary outcome
Percent Correct Speech Intelligibility
Time frame: One hour
Percent of keywords correctly identified by the participant for the processed speech stimuli, listeners were presented with phrases containing several words and they reported back what they heard. The number of words corrected reported by each listener was counted and converted to a 'percent correct' score.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36944186Borrie SA, Yoho SE, Healy EW, Barrett TS. The Application of Time-Frequency Masking To Improve Intelligibility of Dysarthric Speech in Background Noise. J Speech Lang Hear Res. 2023 May 9;66(5):1853-1866. doi: 10.1044/2023_JSLHR-22-00558. Epub 2023 Mar 21.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ideal binary mask in people with Hearing Loss, Sensorineural and Dysarthria, run by Utah State University at 1 site in United States.
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 8 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 26 Mar 2025. 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 26 Mar 2025). 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?
Percent Correct Speech Intelligibility (time frame: One hour). 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 NCT05244603, which also lists 1 linked publication.
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 26 Mar 2025.