CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Sham Treatment: unimodal auditory stimulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02974543
NCT02974543N/ACompleted
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Combined Auditory-Somatosensory Stimulation to Alleviate Tinnitus

University of Michigan·interventional·Posted Nov 28, 2016·Updated May 17, 2017

In Brief

A clinical study evaluating Sham Treatment: unimodal auditory stimulation and Active Treatment: Bimodal auditory-somatosensory stimulation for Tinnitus. Completed, enrolled 35 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTinnitus
CountriesUnited States
CollaboratorsWallace H Coulter Center for Translational Research

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 28, 2016
Enrollment StartSep 1, 2014
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 9.6 years ago

Interventions

Sham Treatment: unimodal auditory stimulationdevice

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 stimulationdevice

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.