Neurobiological Similarities of Tinnitus and PTSD
An Evaluation of Neurobiological Similarities of Tinnitus and Posttraumatic Stress Disorder
2 other identifiers
observational
64
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 4, 2021
CompletedFirst Submitted
Initial submission to the registry
July 31, 2023
CompletedFirst Posted
Study publicly available on registry
August 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedResults Posted
Study results publicly available
July 8, 2025
CompletedJuly 8, 2025
July 1, 2025
3.7 years
July 31, 2023
May 23, 2025
July 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Resting-State Functional MRI
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 from the dataset. A Z-score of 0 represents the population mean. For each of the regions reported in the Auditory Vigilance Network, each positive point represents one standard deviation above the population mean. These positive Z-scores represent more brain activation within these regions.
30 minutes of acquired data
Study Arms (4)
Tinnitus and PTSD (T+P)
Active duty service members and/or veterans with PTSD and tinnitus.
Tinnitus Only (TO)
Active duty service members and/or veterans with only tinnitus/no PTSD.
PTSD Only (PO)
Active duty service members and/or veterans with only PTSD/no tinnitus.
Healthy Controls
Active duty service members and/or veterans with no PTSD and no tinnitus.
Interventions
We will acquire BOLD fMRI images in an unstimulated state using an extended time-series (300 whole-brain volumes over \~ 60-75 min). These data are a main outcome. Data will be processed on an ongoing basis to ensure integrity, and includes controlling for white matter, cerebral spinal fluid, and movement.
The CAPS-5 is a semi-structured interview, conducted by an independent evaluator, that measures DSM-5 symptoms of PTSD. Presence of at least one intrusion symptom, one avoidance symptom, two cognition and mood symptoms, and two arousal symptoms for 1 month or more are required to reach the diagnostic threshold.
Tympanometry will be conducted to assess ear canal volume (cm cubed), maximum pressure (daPa) peak compliance (ml), and type (A, AD, AS, B, B-High, C) for each ear) at 226-Hz admittance.
Tinnitus acoustic assessment (for tinnitus participants only): Tinnitus ear (left, right, bilateral), pitch matched frequency (Hz) and loudness matched intensity (dB) will be conducted. When available, the tinnitus acoustic assessment only will be repeated at the RII, on the same day and prior to the fMRI scan, to demonstrate reproducibility of results.
Otoscopy is a clinical procedure used to examine structures of the ear, particularly the external auditory canal, tympanic membrane, and middle ear
Pure tone air- and bone-conduction threshold will be conducted to evaluate audiometry and masking levels in both ears, from 250 Hz. To 16000 Hz.
Speech testing will be conducted in both ears, which will include speech reception threshold, speech reception threshold masking level, word recognition presentation level, and word recognition masking level.
Loudness discomfort levels will be tested in both right and left ears, from 500Hz to 4000Hz and speech reception threshold.
Quick Speech in Noise Test (QuickSIN) is a quick method for clinicians to quantify a patient's ability to hear in noise (1 minute).
Distortion-Product Otoacoustic Emissions (DPOAE) is an automated evaluation of cochlear function. A sensitive microphone is placed in the ear canal via a probe assembly with a disposable ear-tip attached to perform and record the measurements. DPOAEs will be elicited at multiple frequencies in both ears (10 min).
Eligibility Criteria
This study will consent and screen veterans and active duty service members to include 120 for analysis. Subjects will be recruited from the San Antonio community. Women and minorities will be actively recruited into the study.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Health San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The planned recruitment included 30 participants with both tinnitus and PTSD (T+P); 30 participants with only PTSD (PO); 30 participants with only tinnitus (TO); and 30 healthy controls without PTSD or tinnitus (HC). Groups that were more highly represented included TO (n = 25) and HC (n = 24). Therefore, it is difficult to gain statistical power to assess whether there were significant differences in the BOLD signal for this group.
Results Point of Contact
- Title
- Dr. John Moring
- Organization
- The University of Texas Health Science Center at San Antonio
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 31, 2023
First Posted
August 8, 2023
Study Start
February 4, 2021
Primary Completion
November 1, 2024
Study Completion
November 1, 2024
Last Updated
July 8, 2025
Results First Posted
July 8, 2025
Record last verified: 2025-07