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The Effect of Mild-gain Amplification on Tinnitus Perception in Normal Hearing Adults 15 Double-Blind Crossover Design
Clinical Trial NCT07489807 is an interventional study for Tinnitus that is recruiting. It started on 1 April 2025 with plans to enroll 15 participants. Led by Technical University of Denmark, it is expected to complete by 1 June 2027. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
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 provid...Show More
Official Title
The Effect of Mild-gain Amplification on Tinnitus Perception in Normal Hearing Adults
Conditions
TinnitusOther Study IDs
- H-16036391-1
NCT ID Number
Start Date (Actual)
2025-04-01
Last Update Posted
2026-03-24
Completion Date (Estimated)
2027-06-01
Enrollment (Estimated)
15
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Tinnitus
Hearing aids
Normal hearing
Hearing aids
Normal hearing
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalExperimental: mild gain amplification: (8dB, 1 Hz to 8 kHz) Device: mild gain amplification from hearing aids Amplification of 8dB from 1 Hz to 8 kHz No noise cancelling activated | Hearing Aid with NR 4 The effect of mild gain amplification (8dB covering 1kHz to 8kHz) was tested in a double-blinded crossover study. Its effect was compared to an active placebo treatment |
Placebo ComparatorPlacebo Comparator: no amplification Device: hearing aids with no amplification. No noise cancelling activated | Hearing Aid with NR 4 The effect of mild gain amplification (8dB covering 1kHz to 8kHz) was tested in a double-blinded crossover study. Its effect was compared to an active placebo treatment |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Tinnitus Functional Index | 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 | 3 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Tinnitus loudness | Psychoacoustic measurement where participants match the loudness of their tinnitus to either a pure-tone or noisy sound. The loudness of the matched tone could be changed in 3 decibel steps. | 3 weeks |
Tinnitus spectrum | It was based on the method described by Noreña et al. (2002). The stimuli consisted of either 2-second pure tones (first condition) or 2-second one-third octave noise bands (second condition), with center frequencies spanning from 125 Hz to 14 kHz. These sounds were delivered monaurally through headphones to the ear in which tinnitus was perceived as most intense. When tinnitus perception was equal in both ears, stimulation was applied to the ear with the lower average thresholds at high frequencies. All stimuli were presented at an intensity corresponding to the loudness match of a 1 kHz pure tone, but never below 10 dB sensation level (SL). | 3 weeks |
Visual Analog Scale - annoyance | Likert scale from 0-10 where 0 = "My tinnitus is not annoying" and 10 = "My tinnitus is extremely annoying" | 3 weeks |
Visual Analog Scale - loudness | Likert scale from 0-10 where 0 = "I cannot hear my tinnitus" and 10 = "My tinnitus is extremely loud" | 3 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- Meniere's disease, Tosclerosis, Stapedectomy, Stapedotomy and Tympanoplasty
- Objective or pulsatile tinnitus
- Hearing thresholds >25 dB from 125 Hz to 8 kHz
Technical University of DenmarkStudy Responsible Party
Mie Joergensen, Principal Investigator, Postdoc, Technical University of Denmark
No contact data.
1 Study Locations in 1 Countries
Hearing Systems Section, Lyngby, Denmark
Joergensen, Postdoc, Contact, +45 45 25 25 25, [email protected]
Recruiting