N/A
N=64
Neurobiological Similarities of Tinnitus and PTSD
Posttraumatic Stress Disorder · Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT05981391 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Resting-State Functional MRI — 0.55; 0.35; 0.29; 0.59 Z-Score — p=0.01
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- 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); Pure tone air and bone-conduction (Diagnostic_test); Speech testing (Diagnostic_test); Loudness Discomfort (Diagnostic_test); Quick Speech in Noise Test (Diagnostic_test); Distortion-Product Otoacoustic Emissions (DPOAE) (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resting-State Functional MRI |
0.55; 0.35; 0.29; 0.59; 0.46; 0.36 | 0.01 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Male and female DEERS eligible veterans and active duty service members, ages 18 and above
- preferred language is English and able to read and speak English at a 6th grade level
- those with PTSD (T&P; PO) must meet full criteria for PTSD diagnosis based on the DSM-5 and assessed by an independent evaluator using the CAPS-5
- those with chronic, constant tinnitus (T&P, TO) will be identified by self-report and confirmed with the audiometric assessment.
Exclusion Criteria
- psychiatric hospitalization in the last 12 months
- significant cognitive impairment determined by inability to comprehend screening assessment
- psychiatric problems and/or high suicide risk warranting immediate intervention
- neurobiological disorders, Meniere's disease
- Temporomandibular disorders that affect tinnitus, per self-report
- history of major head trauma with loss of consciousness for 20 minutes or more as determined by the History of Head Injuries questionnaire
- history of seizures
- conditions that would prevent completion of fMRI scan (any type of electronic, mechanical, or magnetic implant, coil, filter, or stent, any type of surgical clip or staple, shunt, any type of metal object, hearing aid, spinal fusion, halo vest, IV access port, eyelid spring, artificial eye, artificial heart valve, biostimulator, severe hyperacusis)
- active conductive pathology/hearing loss as determined by audiometric assessment.
- Those with tinnitus (T&P; TO) will be excluded if their tinnitus is intermittent, objective, or pulsatile, or present for less than 6 months.
Data sourced from ClinicalTrials.gov (NCT05981391). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.