NCT01412918

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 9, 2011

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 18, 2016

Completed
Last Updated

February 29, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

July 6, 2011

Results QC Date

June 23, 2014

Last Update Submit

January 29, 2016

Conditions

Tinnitus

Keywords

TinnitusInhibitor DeviceSCN9 geneRinging in the earsMilwaukeeMedical College of Wisconsin

Outcome Measures

Primary Outcomes (1)

  • Determine the Percentage of Participants for Which the Inhibitor™ Tinnitus Masking Device Effected Tinnitus Perception

    Determine percentage of particpants with a change in tinnitus perception to evaluate the effectiveness of the Inhibitor™ Tinnitus Masking Device.

    Single visit (day 1), assessed the day of visit

Secondary Outcomes (1)

  • Percentage of Participants Which Showed Presence of SCN9 Gene Expression.

    Single visit (day 1), evaluated at the time of the genetic collection.

Study Arms (2)

Tinnitus

EXPERIMENTAL

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

No tinnitus

NO INTERVENTION

Individuals without tinnitus will also be masked with the device.

Interventions

The Inhibitor™ Tinnitus Masking DeviceDEVICE

The Inhibitor™ Tinnitus Masking Device

Tinnitus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18 years,
  • has tinnitus

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Froedtert & The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

  • Reimann F, Cox JJ, Belfer I, Diatchenko L, Zaykin DV, McHale DP, Drenth JP, Dai F, Wheeler J, Sanders F, Wood L, Wu TX, Karppinen J, Nikolajsen L, Mannikko M, Max MB, Kiselycznyk C, Poddar M, Te Morsche RH, Smith S, Gibson D, Kelempisioti A, Maixner W, Gribble FM, Woods CG. Pain perception is altered by a nucleotide polymorphism in SCN9A. Proc Natl Acad Sci U S A. 2010 Mar 16;107(11):5148-53. doi: 10.1073/pnas.0913181107. Epub 2010 Mar 8.

    PMID: 20212137BACKGROUND

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. David Friedland
Organization
Medical College of Wisconsion
dfriedland@mcw.edu
414-805-

Study Officials

  • David R Friedland, MD, Ph.D.

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 6, 2011

First Posted

August 9, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2013

Study Completion

January 1, 2014

Last Updated

February 29, 2016

Results First Posted

January 18, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)