Trial Outcomes & Findings for Application of Ideal Binary Masking to Disordered Speech (NCT NCT05244603)

Last Updated: 2025-03-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

435 participants

Primary outcome timeframe

One hour

Results posted on

2025-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	Normal Hearing Listeners with normal hearing Ideal binary mask: Speech in noise processed by ideal binary mask to reduce background noise	Hearing Impaired Listeners with hearing loss Ideal binary mask: Speech in noise processed by ideal binary mask to reduce background noise
Overall Study STARTED	422	13
Overall Study COMPLETED	422	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Overall represents both groups of listeners, row populations are subgroups

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: One hour

Population: Listeners with normal hearing and listeners with hearing loss

Outcome measures

Outcome measures
Measure	Normal Hearing n=422 Participants Listeners with normal hearing Ideal binary mask: Speech in noise processed by ideal binary mask to reduce background noise	Hearing Impaired n=13 Participants Listeners with hearing loss Ideal binary mask: Speech in noise processed by ideal binary mask to reduce background noise
Percent Correct Speech Intelligibility	69 percentage of words correctly reported Standard Error 1.06	63 percentage of words correctly reported Standard Error 2.2

Adverse Events

Normal Hearing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hearing Impaired

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sarah Yoho Leopold

Utah State University

Phone: 6145708258

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Normal Hearing n=422 Participants Listeners with normal hearing Ideal binary mask: Speech in noise processed by ideal binary mask to reduce background noise	Hearing Impaired n=13 Participants Listeners with hearing loss Ideal binary mask: Speech in noise processed by ideal binary mask to reduce background noise	Total n=435 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	410 Participants n=5 Participants	4 Participants n=7 Participants	414 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Age, Continuous	35 years STANDARD_DEVIATION 12 • n=5 Participants • Overall represents both groups of listeners, row populations are subgroups	69 years STANDARD_DEVIATION 26 • n=7 Participants • Overall represents both groups of listeners, row populations are subgroups	52 years STANDARD_DEVIATION 19 • n=5 Participants • Overall represents both groups of listeners, row populations are subgroups
Sex: Female, Male Female	204 Participants n=5 Participants	7 Participants n=7 Participants	211 Participants n=5 Participants
Sex: Female, Male Male	218 Participants n=5 Participants	6 Participants n=7 Participants	224 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	31 Participants n=5 Participants	0 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	391 Participants n=5 Participants	13 Participants n=7 Participants	404 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	31 Participants n=5 Participants	0 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	0 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) White	363 Participants n=5 Participants	13 Participants n=7 Participants	376 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	422 participants n=5 Participants	13 participants n=7 Participants	435 participants n=5 Participants
Speech intelligibility +5 dB SNR	40 percentage of words correct STANDARD_DEVIATION 5 • n=5 Participants • Overall represents both groups of listeners, row population represents subgroups	24 percentage of words correct STANDARD_DEVIATION 16 • n=7 Participants • Overall represents both groups of listeners, row population represents subgroups	32.5 percentage of words correct STANDARD_DEVIATION 10.5 • n=5 Participants • Overall represents both groups of listeners, row population represents subgroups