Auditory-somatosensory Stimulation to Alleviate Tinnitus

April 7, 2017 updated by: Susan E. Shore, University of Michigan

Combined Auditory-Somatosensory Stimulation to Alleviate Tinnitus

The purpose of this study is to develop and test a subject operated device to lessen tinnitus (ringing in the ear), based on subject-feedback for stimulus presentation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study consented 35 adult subjects. 21 subjects qualified and were randomized into the study. This project will develop and test a device with the ultimate goal of providing a patient operated device to alleviate phantom sound perception, or tinnitus, based on patient-feedback for stimulus presentation.

The device, an electrical-acoustical stimulus timing, is based on physiological findings of stimulus-timing-dependent plasticity in somatosensory and auditory nuclei,that when aberrant, contribute to tinnitus.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Kresge Hearing Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Constant, subjective, preferably unilateral tinnitus without any active external or middle ear pathology.
  2. Hearing thresholds better than 50dB HL at peak tinnitus frequencies.
  3. Able to modulate their tinnitus with a somatic maneuver
  4. BothersomeTinnitus.

Exclusion Criteria:

  • No participation in a tinnitus treatment regimen within the past four weeks
  • Retrocochlear pathology/ VIIIth nerve lesion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sham 1st (Auditory only) then Active (Bimodal)

To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.

During active treatment, the device will deliver electric somatosensory and auditory stimulation.
Device: Sham Treatment: unimodal auditory stimulation
All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.
Device: Active Treatment: Bimodal auditory-somatosensory stimulation

Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.

The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.
Other: Active (Bimodal) then Sham (Auditory only)

During active treatment, the device will deliver electric somatosensory and auditory stimulation.

To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.
Device: Sham Treatment: unimodal auditory stimulation
All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.
Device: Active Treatment: Bimodal auditory-somatosensory stimulation

Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.

The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline
Time Frame: Four weeks on treatment (or sham)
Change in TFI score (mean of weekly assessments for 4 weeks) from baseline for treatment and sham groups. TFI is a clinical questionnaire that assesses tinnitus impact on a subject's quality of life. It uses a scale of 0 - 100 where 0 means no negative impact on quality of life from tinnitus and 100 is devastating impact It will be administered weekly through out the study.
Four weeks on treatment (or sham)
Change in Tinnitus Loudness as Assessed by TinnTester
Time Frame: 4 weeks on treatment (or sham)
Change in Tinnitus matching loudness score (mean of weekly assessments for 4 weeks) from baseline tinnitus matching loudness score, for treatment and sham groups. Subjects are guided through a self-directed computerized assessment software that estimates how loud (in decibels) they perceive their tinnitus to be (TinnTester). This measure was performed at baseline, as well as time points following active, washout, or sham periods.
4 weeks on treatment (or sham)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Wallace H Coulter Center for Translational Research

Investigators

  • Principal Investigator: Susan Shore, Ph.D, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimate)

November 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 17, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00088432

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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