Trial Outcomes & Findings for At-home Auditory Training Clinical Trial (NCT NCT01950013)

NCT ID: NCT01950013

Last Updated: 2019-07-16

Results Overview

The CST is an "objective" measure of speech-understanding in noise that will be obtained when the patient's are wearing their hearing aids. The patient hears standardized recordings of the speech in noise and then reports the sentences that were heard. These are scored as percent correct. Baseline AIDED CST score was obtained prior to the intervention period and immediately following 6-week intervention. The results reflect the CHANGE in CST from pre- to post-intervention with positive numbers indicating improved speech understanding in noise following training.

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

Baseline (prior to training) and 6-weeks later (after training)

Results posted on

2019-07-16

Participant Flow

Recruiting for this study began May 1, 2013 and the final follow-up session took place on February 5, 2015. Forty-five people were recruited from a previous clinical trial on hearing aids in the lab or through newspaper advertisements and flyers.

No changes after enrollment except that 2 subjects withdrew prior to completion--see below.

Participant milestones

Participant milestones
Measure	Passive Control Hearing aid alone	Training Auditory Training Program. Hearing aid plus auditory training Auditory training program: Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids.	Active Control Sham comparator: Active control. Hearing aid plus audio-book use Sham Comparator: Active Control: This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training.
Overall Study STARTED	15	15	15
Overall Study COMPLETED	15	13	15
Overall Study NOT COMPLETED	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Passive Control Hearing aid alone	Training Auditory Training Program. Hearing aid plus auditory training Auditory training program: Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids.	Active Control Sham comparator: Active control. Hearing aid plus audio-book use Sham Comparator: Active Control: This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training.
Overall Study Withdrawal by Subject	0	2	0

Baseline Characteristics

At-home Auditory Training Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Passive Control n=15 Participants Hearing aid alone	Training n=13 Participants Auditory Training Program. Hearing aid plus auditory training Auditory training program: Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids.	Active Control n=15 Participants Sham comparator: Active control. Hearing aid plus audio-book use Sham Comparator: Active Control: This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training.	Total n=43 Participants Total of all reporting groups
Age, Continuous	72.0 years STANDARD_DEVIATION 7.1 • n=5 Participants	71.9 years STANDARD_DEVIATION 6.1 • n=7 Participants	71.3 years STANDARD_DEVIATION 7.5 • n=5 Participants	71.8 years STANDARD_DEVIATION 7.0 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	31 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants	43 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants	43 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	15 participants n=5 Participants	13 participants n=7 Participants	15 participants n=5 Participants	43 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline (prior to training) and 6-weeks later (after training)

Outcome measures

Outcome measures
Measure	Passive Control n=15 Participants Hearing aid alone	Training n=13 Participants Auditory Training Program. Hearing aid plus auditory training Auditory training program: Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids.	Active Control n=15 Participants Sham comparator: Active control. Hearing aid plus audio-book use Sham Comparator: Active Control: This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training.
Change in Connected Speech Test (CST) Score	3.87 percent-correct words Standard Deviation 11.37	-5.84 percent-correct words Standard Deviation 22.54	-9.60 percent-correct words Standard Deviation 16.9

SECONDARY outcome

Timeframe: Baseline (pre-training) and 6 weeks later (post training)

Change in aided performance on the Profile of Hearing Aid Performance (PHAP), a self-report measure of the frequency of listening difficulties experienced by the individual. The aided PHAP scores are proportions of time difficulties encountered in various listening situations while wearing hearing aids. Low PHAP scores indicate less frequent difficulties and reflect better aided performance. The range of possible PHAP scores are 0.0 to 1.0.There are seven subscales of the PHAP and the scores reported are based on the arithmetic means of the five subscales that deal with speech communication, PHAP global. These include the following subscale scores: EC (Ease of Communication), FT (Familiar Talkers), BN (Background Noise), Reverberation (RV) and Reduced Cues (RC). Scores reported below are the CHANGE in aided PHAP global scores, baseline minus post-training.

Outcome measures

Outcome measures
Measure	Passive Control n=15 Participants Hearing aid alone	Training n=13 Participants Auditory Training Program. Hearing aid plus auditory training Auditory training program: Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids.	Active Control n=15 Participants Sham comparator: Active control. Hearing aid plus audio-book use Sham Comparator: Active Control: This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training.
Change in Aided Profile of Hearing Aid Performance (PHAP) Score	-.03 proportion of time had difficulties Standard Deviation .08	.01 proportion of time had difficulties Standard Deviation .09	.00 proportion of time had difficulties Standard Deviation .08

Adverse Events

Passive Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Active Control

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

Larry Humes

Indiana University, Dept of Speech & Hearing Sci

Phone: 812-855-3507

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place