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NCT04661995 · ClinicalTrials.gov registry record · NA
Notched Noise Therapy for Suppression of Tinnitus
A NA study of Tinnitus and Notched Noise Therapy, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 108
- Enrollment target
- 1
- Study location
NCT04661995: Recruiting NA study of Tinnitus and Notched Noise Therapy, sponsored by VA Office of Research and Development.
NCT04661995 is a NA study of Tinnitus and Notched Noise Therapy that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 108 participants, below the 12,615-participant average among 24 other Tinnitus trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04661995, a NA study of Tinnitus and Notched Noise Therapy, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
- 1
- Study location
Study Summary
Tinnitus ("ringing in the ears") has long been a problem for Veterans. The problem continues to escalate due to high levels of noise in the military, and because tinnitus often is associated with traumatic brain injury and post-traumatic stress disorder. In spite of limited research support, sound-based (acoustic) therapies are most often used for tinnitus intervention, and increasing numbers of commercial devices are becoming available that offer various acoustic-stimulus protocols. The proposed study will provide evidence from a randomized controlled trial comparing effects of acoustic-stimulus methods that are purported to suppress tinnitus and/or reduce its functional effects. The study will focus on methods with the strongest scientific rationale, i.e., noise that is notched around the predominant tinnitus-frequency region. Special ear-level devices will deliver these acoustic-therapy protocols that are purported to modify tinnitus-related neural activity. The study will follow a study recently completed by the applicant that provides preliminary evidence supporting this method.
Primary Outcome
The TFI is useful in both clinical and research settings because of its excellent responsiveness to treatment-related change, its high construct validity for scaling the overall severity of tinnitus, and its comprehensive coverage of the negative impacts of tinnitus (Meikle, et al., 2012; Henry, Griest et al., 2016). Participants will complete the TFI at each appointment prior to any audiometric or psychoacoustic testing.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Hearing Aid and Notched Noise Therapy
- COMBINATION_PRODUCT Hearing Aid and Broadband Noise
- DEVICE Hearing Aid
Study Locations (1)
North Carolina
- Durham VA Medical Center, Durham, NC - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
What NCT04661995 shows while recruiting
NCT04661995 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 12,615-participant average among 24 other Tinnitus trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Tinnitus appearing as the primary indexed condition, and to 3 interventions - of which Hearing Aid and Notched Noise Therapy is the first listed.
NCT04661995 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04661995 about?
NCT04661995 is a clinical study titled "Notched Noise Therapy for Suppression of Tinnitus". Tinnitus ("ringing in the ears") has long been a problem for Veterans. The problem continues to escalate due to high levels of noise in the military, and because tinnitus often is associated with traumatic brain injury and post-traumatic stress disorder. In spite of limited research support, sound-b...
What is the current status of trial NCT04661995?
This trial is currently recruiting. It is a NA study. The enrollment target is 108 participants. The study started on 2023-03-01. Estimated completion is 2026-05-31.
What conditions does trial NCT04661995 study?
This clinical trial studies the following conditions: Tinnitus, Notched Noise Therapy.
What interventions are being tested in trial NCT04661995?
The interventions under investigation include: Hearing Aid and Notched Noise Therapy (COMBINATION_PRODUCT), Hearing Aid and Broadband Noise (COMBINATION_PRODUCT), Hearing Aid (DEVICE).
Who is sponsoring clinical trial NCT04661995?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04661995 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tinnitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04661995's enrollment target sits among peer trials
108 10th of 24 higher than 15 of 24 other Tinnitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tinnitus 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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