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Auditory-somatosensory Stimulation to Alleviate Tinnitus

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ClinicalTrials.gov Identifier: NCT02974543
Recruitment Status : Completed
First Posted : November 28, 2016
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
Wallace H Coulter Center for Translational Research
Information provided by (Responsible Party):
Susan E. Shore, University of Michigan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tinnitus Device: Sham Treatment: unimodal auditory stimulation Device: Active Treatment: Bimodal auditory-somatosensory stimulation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Auditory-Somatosensory Stimulation to Alleviate Tinnitus
Study Start Date : September 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974543


Locations
United States, Michigan
University of Michigan Kresge Hearing Research Institute
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Wallace H Coulter Center for Translational Research
Investigators
Principal Investigator: Susan Shore, Ph.D University of Michigan

Responsible Party: Susan E. Shore, Professor, Otolaryngology, Molecular and Integrative Physiology; Professor, Biomedical Engineering Kresge Hearing Research Institute The Joseph Hawkins Collegiate Research Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02974543     History of Changes
Other Study ID Numbers: HUM00088432
First Posted: November 28, 2016    Key Record Dates
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017
Last Verified: April 2017

Keywords provided by Susan E. Shore, University of Michigan:
tinnitus

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