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

Baseline characteristics by cohort
Measure	Total n=435 Participants Total of all reporting groups	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
Age, Categorical <=18 years	0 Participants n=206 Participants	0 Participants n=99 Participants	0 Participants n=107 Participants
Age, Categorical Between 18 and 65 years	414 Participants n=206 Participants	410 Participants n=99 Participants	4 Participants n=107 Participants
Age, Categorical >=65 years	21 Participants n=206 Participants	12 Participants n=99 Participants	9 Participants n=107 Participants
Age, Continuous	52 years STANDARD_DEVIATION 19 • n=206 Participants • Overall represents both groups of listeners, row populations are subgroups	35 years STANDARD_DEVIATION 12 • n=99 Participants • Overall represents both groups of listeners, row populations are subgroups	69 years STANDARD_DEVIATION 26 • n=107 Participants • Overall represents both groups of listeners, row populations are subgroups
Sex: Female, Male Female	211 Participants n=206 Participants	204 Participants n=99 Participants	7 Participants n=107 Participants
Sex: Female, Male Male	224 Participants n=206 Participants	218 Participants n=99 Participants	6 Participants n=107 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	31 Participants n=206 Participants	31 Participants n=99 Participants	0 Participants n=107 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	404 Participants n=206 Participants	391 Participants n=99 Participants	13 Participants n=107 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=206 Participants	0 Participants n=99 Participants	0 Participants n=107 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=206 Participants	4 Participants n=99 Participants	0 Participants n=107 Participants
Race (NIH/OMB) Asian	31 Participants n=206 Participants	31 Participants n=99 Participants	0 Participants n=107 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=206 Participants	0 Participants n=99 Participants	0 Participants n=107 Participants
Race (NIH/OMB) Black or African American	19 Participants n=206 Participants	19 Participants n=99 Participants	0 Participants n=107 Participants
Race (NIH/OMB) White	376 Participants n=206 Participants	363 Participants n=99 Participants	13 Participants n=107 Participants
Race (NIH/OMB) More than one race	0 Participants n=206 Participants	0 Participants n=99 Participants	0 Participants n=107 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=206 Participants	5 Participants n=99 Participants	0 Participants n=107 Participants
Region of Enrollment United States	435 participants n=206 Participants	422 participants n=99 Participants	13 participants n=107 Participants
Speech intelligibility +5 dB SNR	32.5 percentage of words correct STANDARD_DEVIATION 10.5 • n=206 Participants • Overall represents both groups of listeners, row population represents subgroups	40 percentage of words correct STANDARD_DEVIATION 5 • n=99 Participants • Overall represents both groups of listeners, row population represents subgroups	24 percentage of words correct STANDARD_DEVIATION 16 • n=107 Participants • Overall represents both groups of listeners, row population represents subgroups

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