Trial Outcomes & Findings for PC-Based Rehabilitation of Auditory Function (NCT NCT00724347)

NCT ID: NCT00724347

Last Updated: 2015-01-27

Results Overview

Mean consonant identification threshold improvement measure in z-scores (re normal hearing subjects) on consonant and sentence discrimination tests. Additional computerized tests measured auditory short-term verbal memory, and auditory pattern discrimination. The results were compared with baseline performance in the listener group as well as performance in other older hearing impaired subjects who used hearing aids, but who did not undergo training. In the next month, we will published two manuscripts in PLoS ONE describing (1) the benefits of hearing aids on speech comprehension in the absence of perceptual training; (2) the additional benefits of perceptual training. More metholdological details can be found in those manuscripts.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

Subjects will receive two months of PC training and be tested before and after 2-months of training with speech tests in the laboratory..

Results posted on

2015-01-27

Participant Flow

VA patients with hearing loss who wore hearing aids (HAs) were recruited from the VA audiology clinic. Control subjects of similar ages as well as young control subjects were also recruited in order to characaterize speech discrimination capabilities in normal-hearing populations.

Most listeners with hearing loss were tested with and without their hearing aids prior to beginning 8 weeks of at-home PC training.

Participant milestones

Participant milestones
Measure
Arm 1
PC-Based Consonant Discrimination Training: Subjects will receive adaptive training in consonant discrimination on PCs in their homes.
Overall Study
STARTED
18
Overall Study
Baseline Testing
18
Overall Study
COMPLETED
16
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PC-Based Rehabilitation of Auditory Function

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Training Group
n=18 Participants
Hearing impaired subjects with bilateral, symmtrical sloping hearing losses who wore hearing aids
Age, Continuous
65.67 years
STANDARD_DEVIATION 6.51 • n=5 Participants
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
9 Participants
n=5 Participants
Age, Categorical
>=65 years
9 Participants
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
18 Participants
n=5 Participants
Region of Enrollment
United States
18 participants
n=5 Participants
Audiometry
Thresholds 500 Hz
19.69 Sound intensity dB HL
STANDARD_DEVIATION 13.35 • n=5 Participants
Audiometry
Thresholds 1000 Hz
29.38 Sound intensity dB HL
STANDARD_DEVIATION 16.42 • n=5 Participants
Audiometry
Thresholds 2000 Hz
43.13 Sound intensity dB HL
STANDARD_DEVIATION 15.15 • n=5 Participants
Audiometry
Thresholds 4000 Hz
66.88 Sound intensity dB HL
STANDARD_DEVIATION 9.46 • n=5 Participants
Audiometry
Thresholds 6000 Hz
71.25 Sound intensity dB HL
STANDARD_DEVIATION 12.58 • n=5 Participants

PRIMARY outcome

Timeframe: Subjects will receive two months of PC training and be tested before and after 2-months of training with speech tests in the laboratory..

Population: older hearing impaired listeners with hearing aids.

Mean consonant identification threshold improvement measure in z-scores (re normal hearing subjects) on consonant and sentence discrimination tests. Additional computerized tests measured auditory short-term verbal memory, and auditory pattern discrimination. The results were compared with baseline performance in the listener group as well as performance in other older hearing impaired subjects who used hearing aids, but who did not undergo training. In the next month, we will published two manuscripts in PLoS ONE describing (1) the benefits of hearing aids on speech comprehension in the absence of perceptual training; (2) the additional benefits of perceptual training. More metholdological details can be found in those manuscripts.

Outcome measures

Outcome measures
Measure
Training Group
n=16 Participants
Hearing impaired subjects with bilateral, symmtrical sloping hearing losses who wore hearing aids
.Speech Discrimination Ability
Improvement in consonant thresholds
9.43 signal to noise ratio in dB SNR
Standard Deviation 4.84
.Speech Discrimination Ability
Improvement in sentence thresholds
0.46 signal to noise ratio in dB SNR
Standard Deviation 1.23

Adverse Events

Arm 1

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

David L. Woods, Ph.D.

VANCHCS

Phone: 925-372-2571

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place