Neurobiological Similarities of Tinnitus and PTSD

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT05981391
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • resting-state functional MRI — DIAGNOSTIC_TEST
    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.
  • Clinician Administered PTSD Scale for the DSM-5 (CAPS-5) — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    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 Assessment — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    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) — DIAGNOSTIC_TEST
    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).

Study Details

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.

Key Dates

Start date
Feb 4, 2021
Status verified
Jul 2025
Primary completion
Nov 1, 2024
Completion
Nov 1, 2024

Study Design

Enrollment
64 participants (actual)

Arms

  • Arm: Tinnitus and PTSD (T+P)
    Active duty service members and/or veterans with PTSD and tinnitus.
  • Arm: Tinnitus Only (TO)
    Active duty service members and/or veterans with only tinnitus/no PTSD.
  • Arm: PTSD Only (PO)
    Active duty service members and/or veterans with only PTSD/no tinnitus.
  • Arm: Healthy Controls
    Active duty service members and/or veterans with no PTSD and no tinnitus.

Primary Outcome Measure

Resting-State Functional MRI [ Time Frame: 30 minutes of acquired data ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT Health San AntonioSan AntonioTexas78229-

Find similar trials in San Antonio, TX

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
UT Health San Antonio· San Antonio, TX

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