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NCT01294124 · ClinicalTrials.gov registry record
Investigating the Neurobiology of Tinnitus
A clinical trial, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- 218
- Enrollment target
NCT01294124: Completed study, sponsored by Washington University School of Medicine.
NCT01294124 is a clinical trial that has completed, run by Washington University School of Medicine. The registered enrollment target is 218 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01294124 has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- 218 participants
- Enrollment target
Study Summary
The investigators hypothesize that individual differences exist in resting-state cortical attention, control, sensory, and emotion networks prior to noise exposure and these differences predispose some to the development of bothersome tinnitus. Furthermore, the investigators hypothesize that these changes in functional connectivity of these vulnerable systems after noise exposure are responsible for tinnitus. The proposed study will use a case-control cohort study design. Cases will be those soldiers who develop tinnitus and controls will be those who do not. This will be the first prospective study of tinnitus and will provide important information about the neurobiology of tinnitus. If a cortical neural network etiology for bothersome tinnitus is confirmed, it will be an astounding, powerful, paradigm shifting model for the diagnosis, prevention and, most importantly, treatment of tinnitus. Furthermore, if a battery of neurocognitive tests can identify soldiers at risk for the development of tinnitus then appropriate primary prevention strategies can be introduced. There are three Specific Aims to this project. Specific Aim 1. To determine if soldiers who develop tinnitus display pre-deployment differences in a set of physical, functional, cognitive, vulnerability, perpetuating factors, pre-deployment neurocognitive scores, or neuroimaging features compared to soldiers who do not develop tinnitus ("control group"). Specific Aim 2. To determine if particular scores on neurocognitive tests or neuroimaging features of functional/structural connectivity networks are associated with the development of tinnitus. Specific Aim 3. To identify a set of pre-deployment physical, functional, cognitive, vulnerability, and perpetuating factors, neurocognitive responses, and neuroimaging features that are associated with the development of tinnitus. The investigators plan to recruit 200 soldiers, between the ages of 18 and 30 years who do not have hearing loss or tinnitus a
Primary Outcome
The presence of tinnitus will be based on the participants' responses to questions 8a, 9c, and 9d of the Post-Deployment Health Assessment (PDHA).
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2016-05-25 |
| Est. Completion | 2019-07-12 |
What the finished NCT01294124 record still lists
NCT01294124 is an observational study that tracks outcomes without assigning an intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01294124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01294124 about?
NCT01294124 is a clinical study titled "Investigating the Neurobiology of Tinnitus". The investigators hypothesize that individual differences exist in resting-state cortical attention, control, sensory, and emotion networks prior to noise exposure and these differences predispose some to the development of bothersome tinnitus. Furthermore, the investigators hypothesize that these c...
What is the current status of trial NCT01294124?
This trial is currently completed. The enrollment target is 218 participants. The study started on 2016-05-25. Estimated completion is 2019-07-12.
Who is sponsoring clinical trial NCT01294124?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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