At-home Auditory Training Clinical Trial

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01950013
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
• Enrollment: 45
• Location: 1
• Arms: 3
• Duration (Months): 19.1
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effectiveness of an auditory training program used at home with the subject's own hearing aids.

Condition or Disease	Intervention/Treatment	Phase
Presbycusis; Aging; Hearing Loss	Behavioral: Auditory training program; Behavioral: Sham Comparator: Active Control	N/A

Detailed Description

The most common communication complaint of older adults with impaired hearing is that they can hear speech, but can't understand it. This is especially true where there are competing sounds in the background. 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. All testing for the screening, baseline speech testing, training system orientation, and the outcomes portions of this project will be conducted in the Audiology Research Laboratory (ARL) of the Speech and Hearing Center located at 200 South Jordan Avenue. The use of the training program will be done at the subject's home.

Subjects will first come to the ARL for either one session for a hearing aid follow-up and instruction in the use of the training system (Session 1) or for one session for an initial screening to determine eligibility (Screening) followed then by Session 1. Subjects will then take home a training system that includes a tablet computer that has the training program loaded onto it, a portable loudspeaker, and some accessories. There will be three groups of subjects: (1) Hearing aid alone--no training (passive control); (2) Hearing aid plus auditory training (training); and (3) Hearing aid plus audio book use (active control). Total enrollment will be 45 subjects. Those subjects in the training group and active control group will complete a 6-week training period and return to the lab for outcome measures after 6 weeks of training for the primary and secondary outcome measures. The hearing aid alone group will return for the same outcome measures as the training and active control groups, but will have no intervention between these follow-up sessions.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: At-home Auditory Training Clinical Trial
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Passive Control Hearing aid alone
Experimental: Training Auditory Training Program. Hearing aid plus auditory training	Behavioral: 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.
Sham Comparator: Active control Sham comparator: Active control. Hearing aid plus audio-book use	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. Change in Connected Speech Test (CST) Score [Baseline (prior to training) and 6-weeks later (after training)]

   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.

Secondary Outcome Measures

1. Change in Aided Profile of Hearing Aid Performance (PHAP) Score [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• •55-79 yrs of age

• Native English speaker

• Having corrected vision sufficient to read 18pt font on a computer screen

• Wearing binaural hearing aids that were fitted within the past 3 years that are the only hearing aids the subject has ever worn

Exclusion Criteria:

• The hearing aids worn by the subject will be evaluated on the subject's ears and must be functioning as required for this study; otherwise, the subject will be excluded from participation until the hearing aids have been adjusted appropriately

• asymmetrical hearing loss

• presence of dementia, Parkinson's disease, or other neurological disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IU Department of Speech & Hearing Sciences	Bloomington	Indiana	United States	47405-7002

Sponsors and Collaborators

• Indiana University
• National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

• Principal Investigator: Larry E Humes, PhD, Indiana University Department of Speech and Hearing Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Larry Humes, Distinguished Professor, Indiana University
• ClinicalTrials.gov Identifier: NCT01950013
• Other Study ID Numbers: 1303010805; R01DC010135
• First Posted: Sep 25, 2013
• Last Update Posted: Jul 16, 2019
• Last Verified: Jul 1, 2019

• Keywords provided by Larry Humes, Distinguished Professor, Indiana University: Presbycusis; Aging; hearing aids; hearing training
• Additional relevant MeSH terms: Hearing Loss; Presbycusis

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	No changes after enrollment except that 2 subjects withdrew prior to completion--see below.

Arm/Group Title	Passive Control	Training	Active Control
Arm/Group Description	Hearing aid alone	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.	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.
Period Title: Overall Study
STARTED	15	15	15
COMPLETED	15	13	15
NOT COMPLETED	0	2	0

Baseline Characteristics

Arm/Group Title	Passive Control	Training	Active Control	Total
Arm/Group Description	Hearing aid alone	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.	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 of all reporting groups
Overall Participants	15	13	15	43
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72.0 (7.1)	71.9 (6.1)	71.3 (7.5)	71.8 (7.0)
Sex: Female, Male (Count of Participants)
Female	4 26.7%	4 30.8%	4 26.7%	12 27.9%
Male	11 73.3%	9 69.2%	11 73.3%	31 72.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	15 100%	13 100%	15 100%	43 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	15 100%	13 100%	15 100%	43 100%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	15 100%	13 100%	15 100%	43 100%

Outcome Measures

1. Primary Outcome

Title	Change in Connected Speech Test (CST) Score
Description	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.
Time Frame	Baseline (prior to training) and 6-weeks later (after training)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Passive Control	Training	Active Control
Arm/Group Description	Hearing aid alone	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.	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.
Measure Participants	15	13	15
Mean (Standard Deviation) [percent-correct words]	3.87 (11.37)	-5.84 (22.54)	-9.60 (16.9)

2. Secondary Outcome

Title	Change in Aided Profile of Hearing Aid Performance (PHAP) Score
Description	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.
Time Frame	Baseline (pre-training) and 6 weeks later (post training)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Passive Control	Training	Active Control
Arm/Group Description	Hearing aid alone	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.	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.
Measure Participants	15	13	15
Mean (Standard Deviation) [proportion of time had difficulties]	-.03 (.08)	.01 (.09)	.00 (.08)

Adverse Events

Time Frame	6 weeks
Arm/Group Title	Passive Control		Training		Active Control
Arm/Group Description	Hearing aid alone		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.		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.
All Cause Mortality
	Passive Control		Training		Active Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/13 (0%)		0/15 (0%)
Serious Adverse Events
	Passive Control		Training		Active Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/13 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Passive Control		Training		Active Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/13 (0%)		0/15 (0%)

Limitations/Caveats

The findings are limited to the efficacy and effectiveness of a relatively brief (6-week, 3x/week) at-home training regimen for older adults wearing hearing aids. More training could lead to improved benefits in everyday listening.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.