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

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: NCT01412918
Recruitment Status : Terminated (Lack of support to continue)
First Posted : August 9, 2011
Results First Posted : January 18, 2016
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Marcia Dewey, AuD, Medical College of Wisconsin

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Tinnitus
Intervention Device: The Inhibitor™ Tinnitus Masking Device
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tinnitus No Tinnitus
Hide Arm/Group Description

Individual with tinnitus.

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

Individuals without tinnitus.
Period Title: Overall Study
Started 20 1
Completed 20 1
Not Completed 0 0
Arm/Group Title Tinnitus No Tinnitus Total
Hide Arm/Group Description

Individual with tinnitus.

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

Individuals without tinnitus. Total of all reporting groups
Overall Number of Baseline Participants 20 1 21
Hide Baseline Analysis Population Description
The baseline participants with tinnitus demonstrating the Inhibitor™ Tinnitus Masking Device.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 1 participants 21 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
0
   0.0%
20
  95.2%
>=65 years
0
   0.0%
1
 100.0%
1
   4.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 1 participants 21 participants
Female
9
  45.0%
0
   0.0%
9
  42.9%
Male
11
  55.0%
1
 100.0%
12
  57.1%
1.Primary Outcome
Title Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception
Hide Description Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device.
Time Frame Single visit (day 1), assessed the day of visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tinnitus
Hide Arm/Group Description:
Tinnitus. genetic sample collection (no intervention)
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: percentage of participants
76
2.Secondary Outcome
Title Percentage of Participants Which Showed Presence of SCN9 Gene Expression.
Hide Description Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression.
Time Frame Single visit (day 1), evaluated at the time of the genetic collection.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tinnitus No Tinnitus
Hide Arm/Group Description:

Individual with tinnitus.

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

Individuals without tinnitus.
Overall Number of Participants Analyzed 18 1
Measure Type: Number
Unit of Measure: % of participants with gene expression
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tinnitus No Tinnitus
Hide Arm/Group Description

Individual with tinnitus. Intervention: inhibitor device demonstration.

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

Individuals without tinnitus.
All-Cause Mortality
Tinnitus No Tinnitus
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tinnitus No Tinnitus
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tinnitus No Tinnitus
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/1 (0.00%) 
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-
Responsible Party: Marcia Dewey, AuD, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01412918     History of Changes
Other Study ID Numbers: PRO00014763
First Submitted: July 6, 2011
First Posted: August 9, 2011
Results First Submitted: June 23, 2014
Results First Posted: January 18, 2016
Last Update Posted: February 29, 2016