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Central Auditory Processing Deficits Associated With Blast Exposure (CAPD Blast)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01567020
First Posted: March 30, 2012
Last Update Posted: February 8, 2017
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.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: December 15, 2016  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Conditions: Blast Injuries
Brain Injuries
Age Factors
Intervention: Other: Diagnostic

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Control

Non-blast-exposed and non-TBI, aged younger than 50

Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.

Blast

Blast-exposed with or without a TBI diagnosis

Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.

Non-Blast-Exposed TBI

Non-blast-exposed with TBI diagnosis

Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.

Older

Non-blast-exposed and non-TBI, aged 50 or older

Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.


Participant Flow:   Overall Study
    Control   Blast   Non-Blast-Exposed TBI   Older
STARTED   28   46   20   11 
COMPLETED   21   41   18   10 
NOT COMPLETED   7   5   2   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Control

Non-blast-exposed and non-TBI, aged younger than 50

Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.

Blast

Blast-exposed with or without a TBI diagnosis

Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.

Non-Blast-Exposed TBI

Non-blast-exposed with TBI diagnosis

Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.

Older

Non-blast-exposed and non-TBI, aged 50 or older

Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.

Total Total of all reporting groups

Baseline Measures
   Control   Blast   Non-Blast-Exposed TBI   Older   Total 
Overall Participants Analyzed 
[Units: Participants]
 21   41   18   10   90 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      21 100.0%      41 100.0%      18 100.0%      8  80.0%      88  97.8% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      2  20.0%      2   2.2% 
Age 
[Units: Years]
Mean (Standard Deviation)
 31.4  (8.5)   38.4  (11.8)   40.4  (10.9)   56.4  (5.5)   38.82  (12.3) 
Gender 
[Units: Participants]
Count of Participants
         
Female      7  33.3%      2   4.9%      2  11.1%      3  30.0%      14  15.6% 
Male      14  66.7%      39  95.1%      16  88.9%      7  70.0%      76  84.4% 
Region of Enrollment 
[Units: Participants]
         
United States   21   41   18   10   90 


  Outcome Measures

1.  Primary:   Number of Blast-exposed Veterans With Abnormal Abilities in One or More Behavioral Tests of Central Auditory Processing   [ Time Frame: six months ]

2.  Secondary:   Number of Participants With Abnormal Ratings of Self-reported Ability to Process Auditory Information in Various Settings   [ Time Frame: six months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Comprehensive Audiological Examination   [ Time Frame: six months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Functional Hearing Ability in Multitalker Environments   [ Time Frame: six months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Number of Participants With Decreased Amplitudes or Increased Latencies in Electrophysiological Tests of Central Auditory Function   [ Time Frame: six months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Frederick Gallun
Organization: VA Portland Health Care System
phone: 5032208262 ext 57472
e-mail: Frederick.Gallun@va.gov


Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01567020     History of Changes
Other Study ID Numbers: C7755-I
First Submitted: March 2, 2012
First Posted: March 30, 2012
Results First Submitted: December 15, 2016
Results First Posted: February 8, 2017
Last Update Posted: February 8, 2017