Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spectral Dynamics and Speech Understanding by Hearing Impaired People

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01867515
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : April 26, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Hearing Loss, Sensorineural
Intervention Other: Acoustic distortion of speech
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Younger Normally-hearing Listeners Older Normally-hearing Listeners Hearing-impaired Listeners
Hide Arm/Group Description

Participants with auditory thresholds within the normal limits.

  • age 18 to 35
  • individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz

Participants with auditory thresholds within the normal limits.

  • age 36 to 65
  • individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz

individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below

  • age 18 to 65
Period Title: Overall Study
Started 13 12 25
Completed 13 11 14
Not Completed 0 1 11
Arm/Group Title Younger Normally-hearing Listeners Older Normally-hearing Listeners Hearing-impaired Listeners Total
Hide Arm/Group Description

Participants with auditory thresholds within the normal limits.

  • age 18 to 35
  • individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz

Participants with auditory thresholds within the normal limits.

  • age 36 to 65
  • individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz

individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below

  • age 18 to 65
Total of all reporting groups
Overall Number of Baseline Participants 13 11 14 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 11 participants 14 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
10
  90.9%
13
  92.9%
36
  94.7%
>=65 years
0
   0.0%
1
   9.1%
1
   7.1%
2
   5.3%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants 11 participants 14 participants 38 participants
26.5
(20 to 33)
59.1
(51 to 65)
59.4
(48 to 65)
48.0
(20 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 11 participants 14 participants 38 participants
Female
6
  46.2%
5
  45.5%
2
  14.3%
13
  34.2%
Male
7
  53.8%
6
  54.5%
12
  85.7%
25
  65.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 13 participants 11 participants 14 participants 38 participants
13
 100.0%
11
 100.0%
14
 100.0%
38
 100.0%
1.Primary Outcome
Title Percent Correct Words Identified
Hide Description The experimental approach compares speech identification performance among younger, normally-hearing listeners, older normally-hearing listeners and hearing-impaired listeners. Tasks will be carried out in quiet and in the presence of continuous, speech-shaped background noise. The investigators compared the understanding of unprocessed stimuli with 1) time-compressed stimuli, 2) time-compressed stimuli expanded in time via gaps and 3) uncompressed stimuli where portions of the signal were replaced with silence. Experimental metrics were percentage of correct/incorrect speech identification in each listening condition.
Time Frame average of two blocks per condition obtained over the course of up to three 2-hour visits, spaced an average of one week apart
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normally-hearing Listeners Older Normally-hearing Hearing-impaired Listeners
Hide Arm/Group Description:

Participants with auditory thresholds within the normal limits.

  • age 18 to 35
  • individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz

Participants with auditory thresholds within the normal limits.

  • age 36 to 65
  • individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz
individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below
Overall Number of Participants Analyzed 13 11 14
Mean (Full Range)
Unit of Measure: percentage of words identified
Unprocessed speech in quiet
98.6
(88 to 100)
97.1
(84 to 100)
91.9
(64 to 100)
Unprocessed speech in noise
98.8
(88 to 100)
96.2
(72 to 100)
91.3
(68 to 100)
Time-compressed (50%) speech in quiet
95.7
(60 to 100)
96.4
(84 to 100)
86.4
(24 to 100)
Time-compressed (50%) speech in noise
89.5
(72 to 100)
80.2
(60 to 96)
57.9
(8 to 92)
Time-compressed (66%) speech in quiet
92.8
(60 to 100)
86.4
(52 to 100)
66.9
(24 to 100)
Time-compressed (66%) speech in noise
47.7
(8 to 80)
26.2
(4 to 60)
11.3
(0 to 44)
Time-compressed (80%) speech in quiet
39.8
(8 to 88)
12.2
(0 to 60)
7.1
(0 to 64)
Time-compressed (80%) speech in noise
1.4
(0 to 8)
0.7
(0 to 4)
0.3
(0 to 4)
Interrupted (50%) speech in quiet
98.5
(88 to 100)
96.2
(80 to 100)
85.6
(56 to 100)
Interrupted (50%) speech in noise
89.7
(68 to 100)
84.7
(64 to 100)
58.7
(20 to 92)
Interrupted (66%) speech in quiet
98.3
(88 to 100)
94.9
(80 to 100)
73.3
(24 to 100)
Interrupted (66%) speech in noise
69.8
(40 to 84)
60.7
(24 to 84)
36.6
(8 to 84)
Interrupted (80%) speech in quiet
86.3
(60 to 100)
70.7
(8 to 92)
46.1
(4 to 96)
Interrupted (80%) speech in noise
47.1
(20 to 84)
38.9
(4 to 60)
19.7
(0 to 64)
Time-compressed/Expanded (50%) speech in quiet
98.5
(84 to 100)
96.7
(88 to 100)
86.3
(36 to 100)
Time-compressed/Expanded (50%) speech in noise
93.4
(84 to 100)
86.9
(56 to 100)
69.1
(32 to 100)
Time-compressed/Expanded (66%) speech in quiet
98
(72 to 100)
95.6
(80 to 100)
77.4
(40 to 100)
Time-compressed/Expanded (66%) speech in noise
83.7
(40 to 100)
72.7
(24 to 92)
50.7
(10 to 96)
Time-compressed/Expanded (80%) speech in quiet
93.7
(64 to 100)
89.5
(56 to 100)
66
(24 to 100)
Time-compressed/Expanded (80%) speech in noise
75.7
(40 to 100)
57.6
(32 to 76)
30
(4 to 76)
Time Frame over the course of up to three 2-hour visits, spaced an average of one week apart
Adverse Event Reporting Description Sounds presented at a potentially damaging level
 
Arm/Group Title Younger Normally-hearing Listeners Older Normally-hearing Listeners Hearing-impaired Listeners
Hide Arm/Group Description

Participants with auditory thresholds within the normal limits.

  • age 18 to 35
  • individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz

Participants with auditory thresholds within the normal limits.

  • age 36 to 65
  • individuals with hearing thresholds of 20 dB HL or better at all octave frequencies between 250 Hz and 4000 Hz

individuals with bilateral sensorineural hearing losses with thresholds between 25 and 70 dB HL and no losses greater than 70 dB HL at frequencies of 4000 Hz or below

  • age 18 to 65
All-Cause Mortality
Younger Normally-hearing Listeners Older Normally-hearing Listeners Hearing-impaired Listeners
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/11 (0.00%)   0/14 (0.00%) 
Hide Serious Adverse Events
Younger Normally-hearing Listeners Older Normally-hearing Listeners Hearing-impaired Listeners
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/11 (0.00%)   0/14 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Younger Normally-hearing Listeners Older Normally-hearing Listeners Hearing-impaired Listeners
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/11 (0.00%)   0/14 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michelle R. Molis, PhD
Organization: VA Portland HCS, RR&D National Center for Auditory Rehabilitative Research
Phone: 503-220-8262 ext 55574
EMail: michelle.molis@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01867515    
Other Study ID Numbers: C1020-R
5I01RX001020-03 ( U.S. NIH Grant/Contract )
First Submitted: May 20, 2013
First Posted: June 4, 2013
Results First Submitted: September 1, 2017
Results First Posted: April 26, 2018
Last Update Posted: April 26, 2018