Auditory-somatosensory Stimulation to Alleviate Tinnitus

Not Applicable

Completed

• Conditions: Tinnitus

• Registration Number: NCT02974543
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-09
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-28
• Status Verified: 2017-04
• Results First Submitted: 2017-04-07
• Results First Submitted QC: 2017-04-07
• Last Update Submitted: 2017-04-07
• Results First Posted: 2017-05-17
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline	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.
Change in Tinnitus Loudness as Assessed by TinnTester	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.

Trial Locations

Locations (1)

University of Michigan Kresge Hearing Research Institute; 🇺🇸 Ann Arbor, Michigan, United States