Auditory-somatosensory Stimulation to Alleviate Tinnitus
Combined Auditory-Somatosensory Stimulation to Alleviate Tinnitus
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 14, 2016
CompletedFirst Posted
Study publicly available on registry
November 28, 2016
CompletedResults Posted
Study results publicly available
May 17, 2017
CompletedMay 17, 2017
April 1, 2017
1.8 years
November 14, 2016
April 7, 2017
April 7, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
Study Arms (2)
Sham 1st (Auditory only) then Active (Bimodal)
OTHERTo 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.
Active (Bimodal) then Sham (Auditory only)
OTHERDuring 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- No participation in a tinnitus treatment regimen within the past four weeks
- Retrocochlear pathology/ VIIIth nerve lesion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Kresge Hearing Research Institute
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Susan Shore, Professor of Otolaryngology
- Organization
- University of Michigan
Study Officials
- PRINCIPAL INVESTIGATOR
Susan Shore, Ph.D
University of Michigan
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Otolaryngology, Molecular and Integrative Physiology; Professor, Biomedical Engineering Kresge Hearing Research Institute The Joseph Hawkins Collegiate Research Professor
Study Record Dates
First Submitted
November 14, 2016
First Posted
November 28, 2016
Study Start
September 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
May 17, 2017
Results First Posted
May 17, 2017
Record last verified: 2017-04