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NCT01480193 · ClinicalTrials.gov registry record · NA
New Therapy for Patients With Severe Tinnitus
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT01480193: Completed NA study, sponsored by Duke University.
NCT01480193 is a NA study that has completed, run by Duke University. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01480193, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
Tinnitus is a common problem for which there is no universally effective treatment. The best available estimates indicate that 10 - 15% of adults report having tinnitus symptoms, but only 20% of those who report tinnitus suffer from it and subsequently seek treatment. Only formally reported by the U.S. Department of Veterans Affairs (VA), the economic impact of tinnitus is thought to be substantial. The VA reported in 2004 that 289,159 veterans received a disability award for their tinnitus amounting to a total annual compensation amount of over $345.5 million. Individuals with persistent severe tinnitus are unable to habituate to the tinnitus sound that most likely originates in the central auditory system (CAS) in response to peripheral injury. In a widely referenced study, it has been hypothesized that lack of habituation is secondary to abnormal processing of sensory information. Specifically, processing by the limbic system and autonomic nervous system is apparently abnormal in patients with increased levels of cortical arousal and inadequate coping mechanisms. In otolaryngology and audiology clinics, 'sound-based and educational therapies' (SBE) are the focus of most current therapies, and utilize enhanced sound input to the CAS. While SBE treatments may well provide a starting point for tinnitus treatment, additional treatment options are necessary particularly for those with significant non-auditory aspects of tinnitus (e.g., anxiety, depression, interference with daily life) as well as for those who do not experience significant improvement with SBE. Furthermore, commonly used forms of SBE \[e.g.,Tinnitus Retraining Therapy (TRT)\] can require over a year to become effective and may not be used in patients with hearing that is too poor to be modified by sound input. Based on prevalence data from tinnitus sufferers who seek treatment and the known percentage who do not respond to commonly used therapies, we estimate that 1.2 million individuals are not able
Primary Outcome
enrollment, retention, and patient feedback
Interventions
- OTHER Sound Based and Educational Therapies
- OTHER Integrative Medicine Therapies and Sound Based Education Therapies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-11 |
| Phase | NA |
What the finished NCT01480193 record still lists
NCT01480193 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Sound Based and Educational Therapies is the first listed.
NCT01480193 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01480193 about?
NCT01480193 is a clinical study titled "New Therapy for Patients With Severe Tinnitus". Tinnitus is a common problem for which there is no universally effective treatment. The best available estimates indicate that 10 - 15% of adults report having tinnitus symptoms, but only 20% of those who report tinnitus suffer from it and subsequently seek treatment. Only formally reported by the U...
What is the current status of trial NCT01480193?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2011-09. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01480193?
The interventions under investigation include: Sound Based and Educational Therapies (OTHER), Integrative Medicine Therapies and Sound Based Education Therapies (OTHER).
Who is sponsoring clinical trial NCT01480193?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01480193's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 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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