Neurobiological Similarities of Tinnitus and PTSD

NCT05981391 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2025-07-08

Study results available
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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.

Conditions

Interventions

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resting-state functional MRI

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.

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Clinician Administered PTSD Scale for the DSM-5 (CAPS-5)

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.

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Tympanometry

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.

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Tinnitus Assessment

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.

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Otoscopy

Otoscopy is a clinical procedure used to examine structures of the ear, particularly the external auditory canal, tympanic membrane, and middle ear

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Pure tone air and bone-conduction

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.

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Speech testing

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.

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Loudness Discomfort

Loudness discomfort levels will be tested in both right and left ears, from 500Hz to 4000Hz and speech reception threshold.

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Quick Speech in Noise 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).

DIAGNOSTIC_TEST

Distortion-Product Otoacoustic Emissions (DPOAE)

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).

Sponsors & Collaborators

  • Hearing Center of Excellence

    collaborator FED
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-04
Primary Completion
2024-11-01
Completion
2024-11-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05981391 on ClinicalTrials.gov