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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04661995
The ClinicalTrials.gov registry entry for NCT04661995 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,615-participant average among 24 other Tinnitus trials with a reported enrollment target (99% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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