Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by Duke University. The registered enrollment target is 40 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01480193
The ClinicalTrials.gov registry entry for NCT01480193 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sound Based and Educational Therapies is the first listed.
NCT01480193 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.