The Effect of Mild-gain Amplification on Tinnitus Perception in Normal Hearing Adults
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Tinnitus Functional Index
Study Overview
Brief Summary
This study investigated the effect of mild gain amplification (8dB covering 1 Hz to 8kHz) as tinnitus treatment for participants with normal hearing and compared these effects with an active placebo condition using hearing aids without amplification in a double-blinded crossover study. 12 participants with normal hearing and chronic tinnitus were included in the study. Two different hearing aid treatments were provided for 3 weeks each: mild gain amplification that provided 8dB gain in the frequency range from 1 Hz to 8 kHz and no amplification, acting as placebo. The effect of the two treatments on tinnitus distress was evaluated with the Tinnitus Functional Index (TFI) questionnaire. The effect of the treatment on tinnitus loudness and annoyance were evaluated with a visual analog scale (VAS).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Daily bothersome tinnitus for at least 3 months (TFI>15)
- •Normal hearing (25 dB HL from 125 Hz to 8 kHz)
- •Inexperienced hearing aid user
Exclusion Criteria
- •Meniere's disease, Tosclerosis, Stapedectomy, Stapedotomy and Tympanoplasty
- •Objective or pulsatile tinnitus
- •Hearing thresholds >25 dB from 125 Hz to 8 kHz
Outcomes
Primary Outcomes
Tinnitus Functional Index
Time Frame: 3 weeks
Questionnaire assessing tinnitus related distress, consisting on 25 questions that can be answered with likert scale from 0 to 10 where 10 is the most extreme negative value
Secondary Outcomes
- Tinnitus loudness(3 weeks)
- Tinnitus spectrum(3 weeks)
- Visual Analog Scale - annoyance(3 weeks)
- Visual Analog Scale - loudness(3 weeks)
Investigators
Mie Joergensen
Postdoc
Technical University of Denmark