Auditory-somatosensory Stimulation to Alleviate Tinnitus

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Combined Auditory-Somatosensory Stimulation to Alleviate Tinnitus

Conditions
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Tinnitus

Intervention / Treatment
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* Device: Sham Treatment: unimodal auditory stimulation
* Device: Active Treatment: Bimodal auditory-somatosensory stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sham 1st (Auditory only) then Active (Bimodal)<br>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<br>* 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.<br>Device: Active Treatment: Bimodal auditory-somatosensory stimulation<br>* 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.<br>|
| Other: Active (Bimodal) then Sham (Auditory only)<br>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<br>* 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.<br>Device: Active Treatment: Bimodal auditory-somatosensory stimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tinnitus