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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23MH122579 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Hearing Center of Excellence | FED |
| National Institute of Mental Health (NIMH) | NIH |
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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.
Tinnitus and posttraumatic stress disorder (PTSD) are two of the most common service-connected disabilities for active-duty Service Members and Veterans. Tinnitus and PTSD are highly co-morbid, yet distinct disorders. Tinnitus is an auditory disorder in which an illusory auditory percept is experienced, usually as ringing, buzzing, or whooshing sounds, despite no external objective noise source. On the other hand, PTSD is a trauma-related disorder, and is identified by intrusions of the traumatic event, avoidance of reminders, negative alterations in cognition and mood, and hypervigilance or hyperarousal. Similarities between tinnitus and PTSD have been documented among Cambodian refugees, as well as among U.S. Veteran samples. Moreover, the latest neuroimaging data from a recent clinical trial indicated that the auditory-vigilance network was the most dysregulated among active-duty service members with PTSD, compared to combat controls and civilian controls. Due to similar symptoms between tinnitus-related distress and PTSD, and similar dysregulated resting-state brain networks, it remains important to more fully understand how these two distinct disorders may be related. This study will be the first to prospectively examine the overt emotional, behavioral, and cognitive symptoms related to tinnitus-related distress and PTSD, and the overlapping functional connectivity between tinnitus and PTSD. Investigators will examine the overlapping symptoms and neurobiological mechanisms by conducting audiometric and psychological assessments and resting-state functional magnetic resonance imaging (fMRI) among 120 participants (30 with tinnitus and PTSD, 30 with only PTSD, 30 with only tinnitus, and 30 healthy controls). Participants will be recruited from the Frank Tejeda PTSD Clinic and the Audiology Clinic within the South Texas VA Health Care System, and the Hearing Center of Excellence at Lackland Air Force Base. Canonical correlations will be conducted to examine the symptom overlap between tinnitus and PTSD (Aim 1). Investigators aim to neurobiologically characterize tinnitus and PTSD, both separately and conjointly, by conducting fMRI (Aim 2). Investigators also aim to apply modeling to psychometric and neurofunctional data to identify specific regions of the auditory-vigilance network associated with distress related to tinnitus and PTSD. Understanding the shared cognitive, emotional, and behavioral symptoms and neurobiology associated with tinnitus and PTSD will help clinicians and researchers fully understand tinnitus and PTSD independently and conjointly. Results will lead to the identification of neurobiological markers for tinnitus and PTSD, identification of a different phenotype for individuals with both conditions, and development of behavioral and neuro-modulatory therapies that can reduce distress and impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tinnitus and PTSD (T+P) | Active duty service members and/or veterans with PTSD and tinnitus. |
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| Tinnitus Only (TO) | Active duty service members and/or veterans with only tinnitus/no PTSD. |
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| PTSD Only (PO) | Active duty service members and/or veterans with only PTSD/no tinnitus. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Health San Antonio | San Antonio | Texas | 78229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tinnitus and PTSD (T+P) | Active duty service members and/or veterans with PTSD and tinnitus. |
| FG001 | Tinnitus Only (TO) | Active duty service members and/or veterans with only tinnitus/no PTSD. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2024 |
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| Healthy Controls | Active duty service members and/or veterans with no PTSD and no tinnitus. |
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| 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. |
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| 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. |
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| 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. |
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| 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 |
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| 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. |
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| 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. |
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| Loudness Discomfort | Diagnostic Test | 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 | 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). |
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| 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). |
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| FG002 | PTSD Only (PO) | Active duty service members and/or veterans with only PTSD/no tinnitus. |
| FG003 | Healthy Controls | Active duty service members and/or veterans with no PTSD and no tinnitus. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tinnitus and PTSD (T+P) | Active duty service members and/or veterans with PTSD and tinnitus. |
| BG001 | Tinnitus Only (TO) | Active duty service members and/or veterans with only tinnitus/no PTSD. |
| BG002 | PTSD Only (PO) | Active duty service members and/or veterans with only PTSD/no tinnitus. |
| BG003 | Healthy Controls | Active duty service members and/or veterans with no PTSD and no tinnitus. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Z-Score | 30 minutes of acquired data |
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2 months
AEs were assessed each visit. AEs were recorded no matter whether the AE was related to the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tinnitus and PTSD (T+P) | Active duty service members and/or veterans with PTSD and tinnitus. | 0 | 12 | 0 | 12 | 4 | 12 |
| EG001 | Tinnitus Only (TO) | Active duty service members and/or veterans with only tinnitus/no PTSD. | 0 | 25 | 0 | 25 | 1 | 25 |
| EG002 | PTSD Only (PO) | Active duty service members and/or veterans with only PTSD/no tinnitus. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG003 | Healthy Controls | Active duty service members and/or veterans without PTSD and without tinnitus. | 0 | 24 | 0 | 24 | 0 | 24 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased PTSD symptoms after evaluation | Psychiatric disorders | Systematic Assessment |
| ||
| pain from shoulder injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | pain from popped out shoulder during bowling |
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| increased trauma trigger | Psychiatric disorders | Systematic Assessment | due to break-in at home |
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| increased perceived loudness of tinnitus | Ear and labyrinth disorders | Systematic Assessment | due to focus on ringing after entering study |
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| increased tinnitus loudness in both ears | Psychiatric disorders | Systematic Assessment | after audiometric assessment "maybe psychosomatic" |
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| anxiety | Psychiatric disorders | Systematic Assessment | due to MRI scan |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John Moring | The University of Texas Health Science Center at San Antonio | 210-562-6716 | moringj@uthscsa.edu |
| Apr 2, 2025 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 29, 2024 | Nov 21, 2024 | ICF_000.pdf |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000158 | Acoustic Impedance Tests |
| D038781 | Otoscopy |
| D001844 | Bone Conduction |
| D006320 | Hearing Tests |
| ID | Term |
|---|---|
| D003939 | Diagnostic Techniques, Otological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006309 | Hearing |
| D000084323 | Vestibulocochlear Physiological Phenomena |
| D010829 | Physiological Phenomena |
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Left Cerebellum |
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| Left Superior Temporal Gyrus |
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| Left Cingulate Gyrus |
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| Right Lentiform Nucleus |
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| Right Middle Frontal Gyrus |
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| Left Claustrum |
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| Right Supramarginal Gyrus |
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| Left Insula |
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| Left Medial Frontal Gyrus |
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| Right Insula |
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