ClinicalTrials.gg
CompletedNCT05244603Updated Mar 26, 2025Results posted

Application of Ideal Binary Masking to Disordered Speech

An interventional study of Ideal binary mask in Hearing Loss, Sensorineural and Dysarthria, sponsored by Utah State University. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-26.

Sponsored by Utah State University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
435
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hearing Loss, Sensorineural
  • Dysarthria
03

In context

Hearing Loss, Sensorineural

346 studies on the registry are indexed under Hearing Loss, Sensorineural; 100 are open to participants now.

This study's enrollment of 435 is above the median of 32 across 247 interventional studies indexed under Hearing Loss, Sensorineural.

Browse Hearing Loss, Sensorineural studies →

Lead sponsor

Utah State University is the lead sponsor of 39 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:INCLUSION CRITERIA for All Participants

  • Native speakers of American English
  • No history of speech or language impairment
  • No significant prior contact with persons having neurogenic speech disorders

INCLUSION CRITERIA for Participants with Normal Hearing

  • 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

Exclusion Criteria:

  • EXCLUSION CRITERIA for All Participants
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
435 participants (actual)

Study arms

  • Experimental
    Normal Hearing

    Listeners with normal hearing

    Behavioral: Ideal binary mask

  • Experimental
    Hearing Impaired

    Listeners with hearing loss

    Behavioral: Ideal binary mask

Interventions

  • BehavioralIdeal binary mask

    Speech in noise processed by ideal binary mask to reduce background noise

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: One hour

07

Results

Posted Mar 26, 2025

Participant flow

Participant flow — Overall Study
MilestoneNormal HearingHearing Impaired
Started42213
Completed42213
Not completed00

Outcome measures

PrimaryPercent 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.

Time frame:
One hour
Reported as:
Mean · percentage of words correctly reported
Percent Correct Speech Intelligibility
percentage of words correctly reportedNormal HearingHearing Impaired
Percent Correct Speech Intelligibility69 ± 1.0663 ± 2.2

Adverse events

Collected over 2 years 29 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Normal Hearing0/422 (0%)0/422 (0%)0/422 (0%)
Hearing Impaired0/13 (0%)0/13 (0%)0/13 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Normal HearingHearing ImpairedTotal
<=18 years000
Between 18 and 65 years4104414
>=65 years12921
Age, Continuous
Age, Continuous(years)Normal HearingHearing ImpairedTotal
Mean35 ± 1269 ± 2652 ± 19
Sex: Female, Male
Sex: Female, Male(Participants)Normal HearingHearing ImpairedTotal
Female2047211
Male2186224
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Normal HearingHearing ImpairedTotal
Hispanic or Latino31031
Not Hispanic or Latino39113404
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Normal HearingHearing ImpairedTotal
American Indian or Alaska Native404
Asian31031
Native Hawaiian or Other Pacific Islander000
Black or African American19019
White36313376
More than one race000
Unknown or Not Reported505
Region of Enrollment
Region of Enrollment(participants)Normal HearingHearing ImpairedTotal
United States42213435
Speech intelligibility +5 dB SNR
Speech intelligibility +5 dB SNR(percentage of words correct)Normal HearingHearing ImpairedTotal
Mean40 ± 524 ± 1632.5 ± 10.5
08

Study locations

1 site
  • Utah State University
    Logan, Utah 43221, United States
09

References and documents

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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2021 to primary completion in Dec 2023, 24 months.

Results were first posted in Mar 2025, 1 year 3 months after primary completion.

Of 82 non-industry interventional studies with no phase under Hearing Loss, Sensorineural, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 49. This study's 24 months is below that.

Counting every sponsor, half of 162 studies reached it within 22 months; a quarter within 6 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2022
First posted
Feb 17, 2022
StartActual
Dec 1, 2021
Primary completionActual
Dec 1, 2023
CompletionActual
Dec 30, 2023
Results first posted
Mar 26, 2025
Last update
Mar 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05244603
Lead sponsor
Utah State University
Responsible party
Sarah Leopold (Primary Investigator, Utah State University) — Principal investigator
First posted
Feb 17, 2022
Start date
Dec 1, 2021
Primary completion
Dec 1, 2023
Completion
Dec 30, 2023
Results posted
Mar 26, 2025
Last update
Mar 26, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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