Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Purpose
To evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device. To determine if there is a higher incident of expression of the sodium channel, voltage gated, type IX alpha subunit (SCN9) gene in those subjects with disturbing tinnitus than subjects that are not disturbed by tinnitus.

Condition Intervention
Tinnitus
Device: The Inhibitor™ Tinnitus Masking Device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Inhibitor Tinnitus Treatment Masking Device & SCN9 Gene Expression

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device.


Secondary Outcome Measures:
  • Percentage of Participants Which Showed Presence of SCN9 Gene Expression. [ Time Frame: Single visit (day 1), evaluated at the time of the genetic collection. ] [ Designated as safety issue: No ]
    Percentage of participants with and without tinnitus provided a genetic sample via saliva to determine presence of SCN9 gene expression.


Enrollment: 21
Study Start Date: September 2011
Study Completion Date: January 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tinnitus

Individual with tinnitus. Intervention: inhibitor device demonstration.

The Inhibitor™ Tinnitus Masking Device is a new tinnitus treatment device recently available in the United States for use of temporary relief of tinnitus. The device emits an ultra high frequency sound for 60 seconds via bone conduction when applied to the mastoid. Patients reporting tinnitus will be provided the opportunity to demonstrate the device to observe any changes in their tinnitus. The device may be demonstrated up to 5 times. The investigators will be recording the the degree and duration of change in tinnitus perception following treatment with the Inhibitor™ Tinnitus Masking Device.

Device: The Inhibitor™ Tinnitus Masking Device
The Inhibitor™ Tinnitus Masking Device
No Intervention: No tinnitus
Individuals without tinnitus will also be masked with the device.

Detailed Description:
Up to 50 million Americans have tinnitus on a regular basis with between 2-3 million suffering from tinnitus where it affects daily living. The Inhibitor™ Tinnitus Masking Device is a new tinnitus treatment device recently available in the United States for use of temporary relief of tinnitus. The device emits an ultra high frequency sound for 60 seconds via bone conduction when applied to the mastoid. Patients reporting tinnitus will be provided the opportunity to demonstrate the device to observe any changes in their tinnitus. The device may be demonstrated up to 5 times. The investigators will be recording the the degree and duration of change in tinnitus perception following treatment with the Inhibitor™ Tinnitus Masking Device. Patients may provide a genetic sample (typically via saliva sample) to look for expression of a particular genetic marker that may be associated with tinnitus. The investigators will be collect samples from both people with tinnitus and those without tinnitus to use as a control.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • over 18 years,
  • has tinnitus

Exclusion Criteria:

  • Pacemaker,
  • pregnancy,
  • metal implants in head or neck,
  • thrombosis, migraines/headaches,
  • metal bonded retainer, surgeries within the last 6 months which patient is still recovering from,
  • any medical reason your physician would advise against the use of this device,
  • under 18 years
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412918

Locations
United States, Wisconsin
Froedtert & The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
Principal Investigator: David R Friedland, MD, Ph.D. Medical College of Wisconsin
  More Information

Publications:
Responsible Party: Marcia Dewey, AuD, Associate Professor, 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
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Medical College of Wisconsin:
Tinnitus
Inhibitor Device
SCN9 gene
Ringing in the ears
Milwaukee
Medical College of Wisconsin

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on December 07, 2016