Clinical Trials Directory

Trials / Completed

CompletedNCT05271825

Broadband Amplification as Tinnitus Treatment

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
23 (actual)
Sponsor
Technical University of Denmark · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

* The effect of broadband amplification was tested in a double-blinded crossover study * Its effect was compared to an active placebo treatment * An improvement in tinnitus distress was found after use of broadband amplification * No effect was found on the tinnitus loudness

Detailed description

This study investigated the effect of broadband amplification (125 Hz to 10 kHz) as tinnitus treatment for participants with high-frequency hearing loss and compared these effects with an active placebo condition using band-limited amplification (125 Hz to 3-4 kHz). A double-blinded crossover study. 23 participants with a high-frequency (≥ 3 kHz) hearing loss and chronic tinnitus were included in the study and 17 completed the full treatment protocol. Two different hearing aid treatments were provided for 3 months each: broadband amplification that provided gain in the frequency range from 125 Hz to 10 kHz and band-limited amplification that only provided gain in the low frequency range (≤ 3-4 kHz). The effect of the two treatments on tinnitus distress was evaluated with the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI) questionnaires. The effect of the treatment on tinnitus loudness was evaluated with a visual analog scale (VAS) for loudness and a psychoacoustic loudness measure. Furthermore, the tinnitus annoyance was evaluated with a VAS for annoyance. The tinnitus pitch was evaluated based on the tinnitus likeness spectrum.

Conditions

Interventions

TypeNameDescription
DEVICEBroadband amplification from hearing aidsAmplification from 125 Hz to 10 kHz
DEVICEBand-limited amplification from hearing aidsAmplification from 25 Hz to 3-4 kHz

Timeline

Start date
2019-05-01
Primary completion
2021-02-28
Completion
2021-02-28
First posted
2022-03-09
Last updated
2024-04-10

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT05271825. Inclusion in this directory is not an endorsement.