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Completed

NCT Number: NCT02974543

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Kresge Hearing Research Institute

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sham Treatment: unimodal auditory stimulation

Device

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.

Active Treatment: Bimodal auditory-somatosensory stimulation

Device

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Wallace H Coulter Center for Translational Research

Registry information

Official study title

Combined Auditory-Somatosensory Stimulation to Alleviate Tinnitus

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 28, 2016
Registry last updated
May 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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