N/A
N=21
Auditory-somatosensory Stimulation to Alleviate Tinnitus
Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT02974543 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline — -10.08; -5.40; 0.95; -4.34 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sham Treatment: unimodal auditory stimulation (Device); Active Treatment: Bimodal auditory-somatosensory stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in TFI (Tinnitus Functional Index) After Treatment or Sham Compared to Baseline |
-10.08; -5.40; 0.95; -4.34; -2.24; -5.27 | <0.05 sig |
| PRIMARY Change in Tinnitus Loudness as Assessed by TinnTester |
-8.25; -1.52; -3.17; -3.34; -1.67; -7.85 | <0.05 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02974543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.