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NCT05981391 · ClinicalTrials.gov registry record
Neurobiological Similarities of Tinnitus and PTSD
A clinical trial, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- 64
- Enrollment target
NCT05981391: Completed study, sponsored by The University of Texas Health Science Center at San Antonio.
NCT05981391 is a clinical trial that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 64 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05981391 has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- 64 participants
- Enrollment target
Study Summary
Psychiatric distress caused by PTSD may increase attention toward tinnitus, as well as perceived loudness and discomfort. It is important to understand how tinnitus-related distress and PTSD negatively interact together, in order to develop more effective therapeutic approaches. Understanding symptoms and neurobiological mechanisms using functional magnetic resonance imaging (fMRI), can lead to the necessary knowledge to develop effective interventions for individuals who suffer from both conditions.
Primary Outcome
We will acquire BOLD fMRI images in an unstimulated state using an extended time-series (300 whole-brain volumes over \~ 30 min) and assess for activation within the Auditory Vigilance Network. These data are a main outcome. Data were be processed on an ongoing basis to ensure integrity, and includes controlling for white matter, cerebral spinal fluid, and movement. BOLD levels were transformed to Z-scores, a statistical measure that conveys how many standard deviations the data points are away
Interventions
- DIAGNOSTIC_TEST resting-state functional MRI
- DIAGNOSTIC_TEST Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)
- DIAGNOSTIC_TEST Tympanometry
- DIAGNOSTIC_TEST Tinnitus Assessment
- DIAGNOSTIC_TEST Otoscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2021-02-04 |
| Est. Completion | 2024-11-01 |
What the finished NCT05981391 record still lists
NCT05981391 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 64 participants, a relatively small participant target.
The record links to 0 conditions, and to 5 interventions - of which resting-state functional MRI is the first listed.
NCT05981391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05981391 about?
NCT05981391 is a clinical study titled "Neurobiological Similarities of Tinnitus and PTSD". Psychiatric distress caused by PTSD may increase attention toward tinnitus, as well as perceived loudness and discomfort. It is important to understand how tinnitus-related distress and PTSD negatively interact together, in order to develop more effective therapeutic approaches. Understanding sympto...
What is the current status of trial NCT05981391?
This trial is currently completed. The enrollment target is 64 participants. The study started on 2021-02-04. Estimated completion is 2024-11-01.
What interventions are being tested in trial NCT05981391?
The interventions under investigation include: resting-state functional MRI (DIAGNOSTIC_TEST), Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) (DIAGNOSTIC_TEST), Tympanometry (DIAGNOSTIC_TEST), Tinnitus Assessment (DIAGNOSTIC_TEST), Otoscopy (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05981391?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
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