Neurobiological Similarities of Tinnitus and PTSD

CompletedOBSERVATIONAL
Enrollment

64

Participants

Timeline

Start Date

February 4, 2021

Primary Completion Date

November 1, 2024

Study Completion Date

November 1, 2024

Conditions
Posttraumatic Stress DisorderTinnitus
Interventions
DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Otoscopy

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

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Loudness Discomfort

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

DIAGNOSTIC_TEST

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).

Trial Locations (1)

78229

UT Health San Antonio, San Antonio

All Listed Sponsors
collaborator

Hearing Center of Excellence

FED

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

The University of Texas Health Science Center at San Antonio

OTHER

NCT05981391 - Neurobiological Similarities of Tinnitus and PTSD | Biotech Hunter | Biotech Hunter