Trial Outcomes & Findings for Wide Frequency Band Test of Hearing in Veterans (NCT NCT02019888)
NCT ID: NCT02019888
Last Updated: 2021-04-08
Results Overview
Ambient Wideband Absorbance is the experimental middle ear test. Results were compared to the Secondary Outcome Measure of Clinical Peak Static Acoustic Admittance. Wideband absorbance was averaged across frequencies from 250 to 8000 Hz on a ratio scale from 0 to 1. In general, higher absorbance is indicative of a better outcome (i.e., better middle ear function).
COMPLETED
320 participants
Assessed at the time of enrollment during one 2.5- to 3-hour visit.
2021-04-08
Participant Flow
Participant milestones
| Measure |
Normal Hearing Adults
Adults between 20 and 79 years old with hearing at all audiometric frequencies between 250 and 8000 Hz at less than or equal to 25 dB HL
|
Adults With Sensory Neural Hearing Loss
Adults between 20 and 79 years old with sensory neural hearing at one or more audiometric frequencies between 250 and 8000 Hz.
|
Adults With Middle Ear Disorders
Adults between 20 and 89 years old with middle ear disorders: tympanic membrane perforation, serous otitis media, cholesteatoma, otosclerosis, and unspecified middle ear disorders.
|
|---|---|---|---|
|
Overall Study
STARTED
|
148
|
113
|
59
|
|
Overall Study
COMPLETED
|
108
|
83
|
54
|
|
Overall Study
NOT COMPLETED
|
40
|
30
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wide Frequency Band Test of Hearing in Veterans
Baseline characteristics by cohort
| Measure |
Adults With Middle Ear Disorders
n=54 Participants
Adults between 20 and 89 years old with middle ear disorders: tympanic membrane perforation, serous otitis media, cholesteatoma, otosclerosis, and unspecified middle ear disorders.
|
Total
n=245 Participants
Total of all reporting groups
|
Normal Hearing Adults
n=108 Participants
Adults between 20 and 79 years old with hearing at all audiometric frequencies between 250 and 8000 Hz at less than or equal to 25 dB HL
|
Adults With Sensory Neural Hearing Loss
n=83 Participants
Adults between 20 and 79 years old with sensory neural hearing at one or more audiometric frequencies between 250 and 8000 Hz.
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=27 Participants
|
144 Participants
n=483 Participants
|
97 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=27 Participants
|
101 Participants
n=483 Participants
|
11 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
|
Age, Continuous
|
64.69 years
STANDARD_DEVIATION 12.38 • n=27 Participants
|
55.78 years
STANDARD_DEVIATION 17.37 • n=483 Participants
|
43.42 years
STANDARD_DEVIATION 16.12 • n=93 Participants
|
66.07 years
STANDARD_DEVIATION 9.93 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
45 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=27 Participants
|
184 Participants
n=483 Participants
|
63 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=27 Participants
|
240 Participants
n=483 Participants
|
104 Participants
n=93 Participants
|
83 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
9 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=27 Participants
|
220 Participants
n=483 Participants
|
90 Participants
n=93 Participants
|
79 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
54 Participants
n=27 Participants
|
245 Participants
n=483 Participants
|
108 Participants
n=93 Participants
|
83 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Assessed at the time of enrollment during one 2.5- to 3-hour visit.Population: Reflects total number of participants with useable data (reflects where we were in the process of developing the test battery, equipment and software issues, etc.).
Ambient Wideband Absorbance is the experimental middle ear test. Results were compared to the Secondary Outcome Measure of Clinical Peak Static Acoustic Admittance. Wideband absorbance was averaged across frequencies from 250 to 8000 Hz on a ratio scale from 0 to 1. In general, higher absorbance is indicative of a better outcome (i.e., better middle ear function).
Outcome measures
| Measure |
Normal Hearing Adults
n=98 Participants
Adults between 20 and 79 years old with hearing at all audiometric frequencies between 250 and 8000 Hz at less than or equal to 25 dB HL
|
Adults With Sensory Neural Hearing Loss
n=60 Participants
Adults between 20 and 79 years old with sensory neural hearing at one or more audiometric frequencies between 250 and 8000 Hz.
|
Adults With Middle Ear Disorders
n=41 Participants
Adults between 20 and 89 years old with middle ear disorders: tympanic membrane perforation, serous otitis media, cholesteatoma, otosclerosis, and unspecified middle ear disorders.
|
|---|---|---|---|
|
Experimental Middle Ear Test: Ambient Wideband Absorbance
|
0.39 Ratio
Standard Deviation 0.15
|
0.38 Ratio
Standard Deviation 0.15
|
0.32 Ratio
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Assessed at the time of enrollment during one 2.5- to 3-hour visit.Population: This outcome focused on the acoustic reflex part of the test battery which was in development longer than the other outcomes measures. The lower number of participants (in comparison to the number of Baseline Participants) included in this measure reflects the delayed addition of the reflex test to the battery, and missing data due to software or equipment issues.
This measure is middle ear muscle reflex thresholds in decibel (dB) sound pressure level (SPL) elicited in response to a broadband noise (BBN) activator on the standard clinical system and the experimental wideband (WB) system. The range is from 0 to 95 dB SPL with lower thresholds indicating a better outcome.
Outcome measures
| Measure |
Normal Hearing Adults
n=39 Participants
Adults between 20 and 79 years old with hearing at all audiometric frequencies between 250 and 8000 Hz at less than or equal to 25 dB HL
|
Adults With Sensory Neural Hearing Loss
n=47 Participants
Adults between 20 and 79 years old with sensory neural hearing at one or more audiometric frequencies between 250 and 8000 Hz.
|
Adults With Middle Ear Disorders
n=40 Participants
Adults between 20 and 89 years old with middle ear disorders: tympanic membrane perforation, serous otitis media, cholesteatoma, otosclerosis, and unspecified middle ear disorders.
|
|---|---|---|---|
|
Middle Ear Muscle Reflex Test
Clinical System
|
85.45 middle ear muscle reflex in dB SPL
Standard Deviation 7.90
|
92.02 middle ear muscle reflex in dB SPL
Standard Deviation 3.86
|
94.36 middle ear muscle reflex in dB SPL
Standard Deviation 3.05
|
|
Middle Ear Muscle Reflex Test
Experimental Wideband System
|
69.54 middle ear muscle reflex in dB SPL
Standard Deviation 11.89
|
86.99 middle ear muscle reflex in dB SPL
Standard Deviation 7.60
|
93.27 middle ear muscle reflex in dB SPL
Standard Deviation 6.68
|
SECONDARY outcome
Timeframe: Assessed at the time of enrollment during one 2.5- to 3-hour visit.Population: The lower number of participants (compared to the number of Baseline Participants) included in this measure reflects missing data due to software or equipment issues.
This measure is the difference between otoacoustic emissions and noise levels in decibels (dB) sound pressure level (SPL) elicited by a chirp averaged across frequencies from 1000 to 8000 Hertz (Hz). The normal range is \~0 to 20 dB SPL with larger values being better.
Outcome measures
| Measure |
Normal Hearing Adults
n=98 Participants
Adults between 20 and 79 years old with hearing at all audiometric frequencies between 250 and 8000 Hz at less than or equal to 25 dB HL
|
Adults With Sensory Neural Hearing Loss
n=60 Participants
Adults between 20 and 79 years old with sensory neural hearing at one or more audiometric frequencies between 250 and 8000 Hz.
|
Adults With Middle Ear Disorders
n=41 Participants
Adults between 20 and 89 years old with middle ear disorders: tympanic membrane perforation, serous otitis media, cholesteatoma, otosclerosis, and unspecified middle ear disorders.
|
|---|---|---|---|
|
Wideband Otoacoustic Emission Test
|
10.29 difference level in dB SPL
Standard Deviation 2.56
|
4.29 difference level in dB SPL
Standard Deviation 1.06
|
3.30 difference level in dB SPL
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: Assessed at the time of enrollment during one 2.5- to 3-hour visit.Population: Reflects total number of participants with useable data (reflects where we were in the process of developing the test battery, equipment and software issues, etc.).
Peak Static Acoustic Admittance is the standard clinical middle ear test. Results were compared to the Primary Outcome Measure of Ambient Wideband Absorbance. Peak Static Acoustic Admittance estimated from a 226-Hz tympanogram is measured on a mmho scale from 0.00 mmho to \~5.0 mmho. The normal range (i.e., normal middle ear function) is 0.3 to 1.7 mmho.
Outcome measures
| Measure |
Normal Hearing Adults
n=98 Participants
Adults between 20 and 79 years old with hearing at all audiometric frequencies between 250 and 8000 Hz at less than or equal to 25 dB HL
|
Adults With Sensory Neural Hearing Loss
n=60 Participants
Adults between 20 and 79 years old with sensory neural hearing at one or more audiometric frequencies between 250 and 8000 Hz.
|
Adults With Middle Ear Disorders
n=41 Participants
Adults between 20 and 89 years old with middle ear disorders: tympanic membrane perforation, serous otitis media, cholesteatoma, otosclerosis, and unspecified middle ear disorders.
|
|---|---|---|---|
|
Clinical Middle Ear Test: Peak Static Acoustic Admittance
|
0.7 admittance in mmho
Standard Deviation 0.24
|
0.8 admittance in mmho
Standard Deviation 0.35
|
0.81 admittance in mmho
Standard Deviation 0.85
|
Adverse Events
Normal Hearing Adults
Adults With Sensory Neural Hearing Loss
Adults With Middle Ear Disorders
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place