Inhibitor Masking Device & Sodium Channel, Voltage Gated, Type IX Alpha Subunit (SCN9) Gene Expression

This study has been terminated.
(Lack of support to continue)
Sponsor:
Information provided by (Responsible Party):
Marcia Dewey, AuD, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01412918
First received: July 6, 2011
Last updated: January 29, 2016
Last verified: January 2016
Results First Received: June 23, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Tinnitus
Intervention: Device: The Inhibitor™ Tinnitus Masking Device

  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
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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
Tinnitus

Individual with tinnitus.

The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device

No Tinnitus Individuals without tinnitus.

Participant Flow:   Overall Study
    Tinnitus     No Tinnitus  
STARTED     20     1  
COMPLETED     20     1  
NOT COMPLETED     0     0  



  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.
The baseline participants with tinnitus demonstrating the Inhibitor™ Tinnitus Masking Device.

Reporting Groups
  Description
Tinnitus

Individual with tinnitus.

The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device

No Tinnitus Individuals without tinnitus.
Total Total of all reporting groups

Baseline Measures
    Tinnitus     No Tinnitus     Total  
Number of Participants  
[units: participants]
  20     1     21  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     0     20  
>=65 years     0     1     1  
Gender  
[units: participants]
     
Female     9     0     9  
Male     11     1     12  



  Outcome Measures
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1.  Primary:   Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception   [ Time Frame: Single visit (day 1), assessed the day of visit ]

2.  Secondary:   Percentage of Participants Which Showed Presence of SCN9 Gene Expression.   [ Time Frame: Single visit (day 1), evaluated at the time of the genetic collection. ]


  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. David Friedland
Organization: Medical College of Wisconsion
phone: 414-805-
e-mail: dfriedland@mcw.edu


Publications:

Responsible Party: Marcia Dewey, AuD, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01412918     History of Changes
Other Study ID Numbers: PRO00014763
Study First Received: July 6, 2011
Results First Received: June 23, 2014
Last Updated: January 29, 2016
Health Authority: United States: Institutional Review Board