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
| Type | Name | Description |
|---|---|---|
| DEVICE | Broadband amplification from hearing aids | Amplification from 125 Hz to 10 kHz |
| DEVICE | Band-limited amplification from hearing aids | Amplification 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.