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Clinical Applications for Time-Compressed Speech Tests

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00371839
First received: August 31, 2006
Last updated: November 17, 2014
Last verified: November 2014
Results First Received: November 6, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hearing Loss
Intervention: Procedure: Audiological Evaluation

  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
Veterans from 50 to 75 years of age with hearing loss, not hearing aid wearers

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

After audiometric thresholds were tested, subjects were assigned to one of three groups based on their pure tone averages (PTA) of thresholds at 500, 1000, 2000, and 4000 Hz. The groups were:

Mild (PTAs of 20-39 decibels (dB) hearing level (HL) Moderate (PTAs of 40-49 dB HL) Moderate-Severe (PTAs over 50 dB HL)


Reporting Groups
  Description
Mild HL

Average hearing loss between 20 and 39 decibels hearing level (HL)

Study performance on cognitive and hearing tests

Audiological Evaluation: Tests of hearing, cognition, and speech perception

Mod HL

Average hearing loss between 40 and 49 decibels hearing level (HL)

Study performance on cognitive and hearing tests

Audiological Evaluation: Tests of hearing, cognition, and speech perception

ModSev HL

Average hearing loss greater than 50 decibels hearing level (HL)

Study performance on cognitive and hearing tests

Audiological Evaluation: Tests of hearing, cognition, and speech perception


Participant Flow:   Overall Study
    Mild HL     Mod HL     ModSev HL  
STARTED     49     20     9  
COMPLETED     32     13     7  
NOT COMPLETED     17     7     2  
Death                 4                 0                 0  
Withdrawal by Subject                 7                 4                 0  
Lost to Follow-up                 6                 3                 2  



  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.
Number of participants who completed the study

Reporting Groups
  Description
Mild HL

Average hearing loss between 20 and 39 decibels hearing level (HL)

Study performance on cognitive and hearing tests

Audiological Evaluation: Tests of hearing, cognition, and speech perception

Mod HL

Average hearing loss between 40 and 49 decibels hearing level (HL)

Study performance on cognitive and hearing tests

Audiological Evaluation: Tests of hearing, cognition, and speech perception

ModSev HL

Average hearing loss greater than 50 decibels hearing level (HL)

Study performance on cognitive and hearing tests

Audiological Evaluation: Tests of hearing, cognition, and speech perception

Total Total of all reporting groups

Baseline Measures
    Mild HL     Mod HL     ModSev HL     Total  
Number of Participants  
[units: participants]
  32     13     7     52  
Age  
[units: years]
Mean ± Standard Deviation
  59.9  ± 6.8     62.7  ± 7.0     65.1  ± 5.1     61.7  ± 5.1  
Gender  
[units: participants]
       
Female     1     1     1     3  
Male     31     12     6     49  



  Outcome Measures

1.  Primary:   Ability to Understand Speech in Noise Background   [ Time Frame: one year ]


  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. Marjorie R. Leek
Organization: Portland VAMC
phone: (909)825-7084 ext 7293
e-mail: Marjorie.Leek@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00371839     History of Changes
Other Study ID Numbers: C4338-R
Study First Received: August 31, 2006
Results First Received: November 6, 2014
Last Updated: November 17, 2014
Health Authority: United States: Federal Government