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NCT03904264 · ClinicalTrials.gov registry record · NA
Feasibility and Acceptability of Using Low-Gain Hearing Aids for Bothersome Tinnitus
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 65
- Enrollment target
NCT03904264: Completed NA study, sponsored by VA Office of Research and Development.
NCT03904264 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 65 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03904264, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
Study Summary
Tinnitus - defined as ringing, humming, or other sounds in the ears or head - is a very common problem for Veterans. Hearing aids that deliver low-level amplification are being used by audiologists to help people with tinnitus who also have normal hearing. However, there is a lack of research evidence showing that this practice is effective. Despite this fact, the practice clearly is spreading. Reports from audiologists in the field as well as research presentations refer to hearing aids being used in this way. Use of hearing aids has been shown to reduce distress from tinnitus for people with hearing loss. Additionally, the use of external sound to help reduce the impact of tinnitus has been shown to be effective. There is clearly a gap in the research regarding the use of hearing aids as a therapeutic method to manage tinnitus when hearing is considered normal. This study will obtain pilot data evaluating people with normal hearing and bothersome tinnitus to find out whether low-level amplification through hearing aids may provide benefit.
Primary Outcome
The Tinnitus Functional Index (TFI) is a statistically validated measure of the functional impact of tinnitus. The TFI was developed to be sensitive to changes in function as a result of intervention for tinnitus. Range is 0 - 100, higher numbers indicates greater level of distress and functional impact.
Interventions
- DEVICE Receiver in the canal (RIC) hearing aids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2020-02-24 |
| Est. Completion | 2022-09-30 |
| Phase | NA |
What the finished NCT03904264 record still lists
NCT03904264 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Receiver in the canal (RIC) hearing aids is the first listed.
NCT03904264 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03904264 about?
NCT03904264 is a clinical study titled "Feasibility and Acceptability of Using Low-Gain Hearing Aids for Bothersome Tinnitus". Tinnitus - defined as ringing, humming, or other sounds in the ears or head - is a very common problem for Veterans. Hearing aids that deliver low-level amplification are being used by audiologists to help people with tinnitus who also have normal hearing. However, there is a lack of research eviden...
What is the current status of trial NCT03904264?
This trial is currently completed. It is a NA study. The enrollment target is 65 participants. The study started on 2020-02-24. Estimated completion is 2022-09-30.
What interventions are being tested in trial NCT03904264?
The interventions under investigation include: Receiver in the canal (RIC) hearing aids (DEVICE).
Who is sponsoring clinical trial NCT03904264?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03904264's enrollment target sits among peer trials
65 1144th of 2000 higher than 854 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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