Posttraumatic Stress SymptomsSANI-TNCT07868055
Self-administered Neurostimulation Intervention for Firefighter Traumatic Stress to Reduce Alcohol Use: Pilot Study
A study testing Transcutaneous auricular neurostimulation (tAN) in people with Posttraumatic Stress Symptoms and Heavy Alcoholic Consumption, run by University of Cincinnati.
Trial summary
The goal of this clinical trial is to evaluate the feasibility, acceptability, and appropriateness of a transcutaneous auricular neurostimulation (tAN) protocol in firefighters who engage in heavy drinking, have at least a mild alcohol use disorder, and report above-average posttraumatic stress symptoms (PTS). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Posttraumatic Stress Symptoms, Heavy Alcoholic Consumption, Alcohol Use Disorder (AUD)
- What is being tested?
- Transcutaneous auricular neurostimulation (tAN)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2027to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Active-duty firefighter aged 18 to 64 years old.
- Endorse at least one heavy drinking event within the past month based on sex-assigned-at-birth thresholds (males: 5+ standard drinks on a single day and/or 15+ over 7 days; females: 4+ standard drinks on a single day and/or 8+ over 7 days).
- Meet DSM-5 criteria for mild, moderate, or severe alcohol use disorder. Report at least moderate posttraumatic stress (PTS) symptoms, defined as a PTSD Checklist for DSM-5 (PCL-5) score of 20 or greater.
- Willing to attend research visits, complete EMA measurements, use the study device, and provide informed consent in English.
Who cannot join
- Currently engaged in evidence-based PTSD psychotherapy or AUD-focused counseling at the time of randomization, or has experienced a past-month change in PTSD- or AUD-relevant medication.
- High risk for moderate to severe alcohol withdrawal syndrome, indicated by a Prediction of Alcohol Withdrawal Severity Scale (PAWSS) score of 4 or greater.
- Unmedicated psychotic disorder or unmedicated bipolar disorder with a manic episode in the past month.
- History of epileptic seizures, neurological diseases, or traumatic brain injury with lasting effects.
- Current evidence of an uncontrolled and/or clinically significant medical or psychiatric condition precluding device-related research participation.
- Suicide attempt in the past month leading to hospital admission, or expressed suicidal ideation with intent and plan in the past month.
Show all 9Show fewer
- Presence of devices such as pacemakers, cochlear prostheses, or neurostimulators.
- Current ear infection or abnormal ear anatomy that would prevent therapeutic earpiece contact to at least one ear.
- Pregnant, lactating, or a person of childbearing potential not using adequate contraception.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Developing and Evaluating a Firefighter Self-administered Neurostimulation Intervention for Traumatic Stress to Reduce Alcohol Use
The goal of this clinical trial is to evaluate the feasibility, acceptability, and appropriateness of a transcutaneous auricular neurostimulation (tAN) protocol in firefighters who engage in heavy drinking, have at least a mild alcohol use disorder, and report above-average posttraumatic stress symptoms (PTS).
The main questions it aims to answer are:
Read more
- How feasible do firefighter participants rate the study procedures on the Feasibility of Intervention Measure?
- How do firefighter participants rate the acceptability of the study procedures (Acceptability of Intervention Measure) and the appropriateness of the tAN device (Intervention Appropriateness Measure)?
Researchers will compare an active tAN condition (receiving therapeutic stimulation from the Sparrow device) to an active sham condition (receiving stimulation below a therapeutic level) to see if the intervention reduces PTS symptom severity and heavy drinking events, and to evaluate the clinical effects on insomnia, mental health symptoms, and quality of life.
Participants will:
- Use the Sparrow device for at least 1 hour/day for 5 days/week throughout a 4-week treatment phase.
- Complete daily measures of traumatic event exposure, PTS symptom severity, alcohol use, and trauma-related drinking motivations.
- Complete audio journals capturing their experience with symptoms and the device.
- Wear sensors to record heart rate, heart rate variability, and sleep data throughout the intervention phase.
Complete assessments immediately following treatment (Week 4) and one month later (Week 8).
Read the detailed description
The investigators' goal is to evaluate the feasibility, acceptability, and appropriateness of a transcutaneous auricular neurostimulation (tAN) protocol for firefighters with alcohol use disorder (AUD) and co-occurring posttraumatic stress (PTS) symptoms. Firefighters are repeatedly exposed to potentially traumatic events, and many experience PTS symptoms as a result. Over 50% of firefighters report past-month heavy alcohol use, and many use alcohol to "self-medicate" symptoms of hyperarousal, intense negative affect, and insomnia that follow traumatic events. tAN, a patient-administered intervention that delivers electrical stimulation to branches of the vagus and trigeminal nerves, has shown promise for alleviating symptoms of PTS and opioid withdrawal. However, its effects have yet to be tested in a sample of firefighters with AUD and co-occurring PTS symptoms. Within this highly impacted population, providing a culturally informed tAN intervention promises to reduce the PTS symptoms driving heavy alcohol use. Study results, utilizing the ear-worn Sparrow device, will inform a revised trial protocol and an FDA pre-submission to support a PTS/AUD indication. In summary, the investigators will examine whether the study protocol is feasible and whether active tAN provides preliminary evidence of reducing PTS symptoms and heavy drinking events compared to an active sham.
Design: The investigators will randomize 20 active-duty firefighters who engage in heavy drinking and report at least moderate PTS symptoms to receive: 1) active tAN or 2) active sham tAN. tAN is administered via the Sparrow device for at least 1 hour per day, 5 days per week, throughout a 4-week treatment phase. Assessments will be collected at Baseline (Week 0), Interim (Week 2), Post-treatment (Week 4), and 1-month follow-up (Week 8), alongside daily ecological momentary assessments and audio journals. The primary outcome will be posttreatment ratings on the Feasibility of Intervention Measure (FIM). Secondary outcomes include ratings of protocol acceptability (Acceptability of Intervention Measure; AIM) and device appropriateness (Intervention Appropriateness Measure; IAM). Exploratory clinical outcomes include the PTSD Checklist for DSM-5 (PCL-5) and heavy drinking events. Biomarker and ecological momentary assessment (EMA) analysis will examine the dynamic relationships between neurostimulation, autonomic arousal (heart rate, heart rate variability), sleep, trauma exposure, and alcohol motives.
Aim (1): Evaluate the feasibility, acceptability, and appropriateness of the study protocol and Sparrow intervention for a firefighter population with AUD and co-occurring PTS symptoms.
Hypothesis 1a: The protocol and intervention will be feasible, acceptable, and appropriate, as indicated by mean scores of 4 or greater on the FIM, AIM, and IAM.
Hypothesis 1b: The trial will meet feasibility benchmarks, including a dropout rate ≤30%, ≥80% device adherence, >50% EMA completion, and ≥80% blinding effectiveness.
Exploratory Aim (1): Assess whether the results provide preliminary support for the efficacy of the active tAN device in reducing PTS symptoms and heavy drinking events compared to sham tAN.
Exploratory Hypothesis (1): Active tAN will result in larger mean pre-post reductions and a higher percentage of clinically meaningful change in PCL-5 total scores and heavy drinking events compared to active sham tAN.
Exploratory Aim (2): Develop longitudinal data analysis strategies to examine dynamic relationships between participants' duty status, ongoing trauma exposure, PTS symptoms, alcohol use/motives, autonomic arousal, sleep patterns, and device usage.
The long-term objective of this feasibility pilot is to use the data to validate the FDA clearance strategy, inform revisions to the study protocol, and support an R01 application for a fully powered Phase II RCT.
- Being tested
- Transcutaneous auricular neurostimulation (tAN), Active Sham
- Keywords
- posttraumatic stress symptoms, transcutaneous auricular neurostimulation, vagus nerve stimulation, trigeminal nerve stimulation, alcohol use disorder, firefighter
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous auricular neurostimulation (tAN)Device
Also called Sparrow Link
The research version of Spark's Sparrow Ascent for vagus and trigeminal nerve stimulation provided through a disposable earpiece that attaches to the ear. The device allows the participant to self-administer stimulation when they choose.
Active ShamDevice
Also called Sparrow Link
Same research device as the active tAN condition, but programmed with active sham parameters such that the stimulation is sufficient to be felt on the skin, but subtherapeutic.
| Study group | Role | What they receive |
|---|---|---|
| Active tAN | Experimental | Transcutaneous auricular neurostimulation (tAN) applied for at least 1 hour per day, for at least 5 days per week, for at 4 week treatment phase. Frequency: 25 Hz on ABVN region, 100Hz on ATN region; pulse width: 250 µs; duty cycle: 5 minutes on, 10 seconds off. Receives: Device: Transcutaneous auricular neurostimulation (tAN) |
| Active Sham | Sham comparator | Same research device as the Active tAN condition, but programmed to deliver perceptible but subtherapeutic stimulation. Frequency: 1 Hz on outer region (ATN), Pulse width: up to 250 µs, Duty cycle: 1 minute on, 5 minutes off. Receives: Device: Active Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol Feasibility as Assessed by the Feasibility of Intervention Measure (FIM)
The FIM is a 4-item self-report questionnaire assessing the extent to which participants agree that the study protocol is feasible to implement. Items are rated on a 5-point Likert scale ranging from 1 ("Completely disagree") to 5 ("Completely agree"). Scores are calculated as an average across items (ranging from 1 to 5), with higher scores indicating greater feasibility. Feasibility success is predefined as a mean score of at least 4.
Measured: Post-treatment (Week 4) and 1-month follow-up (Week 8)
Secondary outcomes (6)
Protocol Acceptability as Assessed by the Acceptability of Intervention Measure (AIM)
The AIM is a 4-item self-report questionnaire evaluating the degree to which participants perceive the study protocol to be acceptable. Items are rated on a 5-point Likert scale from 1 ("Completely disagree") to 5 ("Completely agree"). Scores are averaged across items (range: 1 to 5), where higher scores indicate greater acceptability (benchmark: mean at least 4).
Measured: Post-treatment (Week 4) and 1-month follow-up (Week 8)
Device Appropriateness as Assessed by the Intervention Appropriateness Measure (IAM)
The IAM is a 4-item self-report questionnaire assessing the perceived fit, relevance, and suitability of the Sparrow device for this population. Items are rated on a 5-point Likert scale from 1 ("Completely disagree") to 5 ("Completely agree"). Scores are averaged across items (range: 1 to 5), with higher scores reflecting greater appropriateness (benchmark: mean at least 4).
Measured: Post-treatment (Week 4) and 1-month follow-up (Week 8)
Protocol Feasibility: Participant Retention Rate
Calculated as the percentage of randomized participants who complete the study through the Week 4 assessment. A study dropout rate > 30% will indicate the need for protocol modification.
Measured: Baseline (Week 0) through Week 4
Protocol Feasibility: Sparrow Device Adherence Rate
Calculated as the percentage of participants who adhere to the minimum required stimulation dosage (at least 1 hour/day, 5 days/week) for at least 75% of the 4-week active treatment period, measured via automated device usage logs. The feasibility benchmark is achieved if at least 80% of participants meet this threshold.
Measured: Daily throughout the 4-week treatment phase (Weeks 1-4)
Protocol Feasibility: Ecological Momentary Assessment (EMA) Completion Rate
Calculated as the percentage of prompted daily EMA surveys successfully completed by participants across the 4-week active phase. An overall completion rate of 50% or below will indicate the need for protocol modification.
Measured: Daily throughout the 4-week treatment phase (Weeks 1 through 4)
Blinding Effectiveness Assessment
Assessed by asking participants to guess their condition assignment (Active tAN vs. Active Sham) and their confidence in that guess. Effective blinding is operationalized as at least 80% of participants remaining blind to condition.
Measured: Post-treatment (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start1 Sep 2027 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Firefighters are randomly assigned to receive active tAN or active Sham for the treatment phase (4 weeks).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Joel G Sprunger, PhD, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868055
- Sponsor's protocol ID
- R34AA032824
- Other IDs
- R34AA032824
- Acronym
- SANI-T
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All de-identified human subjects data will be submitted to the NIAAADA. Proprietary Spark Biomedical, Inc. tAN protocols will not be shared. We will share non-proprietary syntax and software solutions created to publish findings from this project. We will upload supporting documents (e.g., study protocols, assessment schedules, data dictionaries, and analytic algorithms used for publications) to the NDA to facilitate reuse.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating a Firefighter Self-administered Neurostimulation Intervention for Traumatic Stress to Reduce Alcohol Use
- ClinicalTrials.gov ID
- NCT07868055
- Acronym / sponsor ID
- SANI-T / R34AA032824
- Keywords
- posttraumatic stress symptoms, transcutaneous auricular neurostimulation, vagus nerve stimulation, trigeminal nerve stimulation, alcohol use disorder, firefighter
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Sep 2027 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the feasibility, acceptability, and appropriateness of a transcutaneous auricular neurostimulation (tAN) protocol in firefighters who engage in heavy drinking, have at least a mild alcohol use disorder, and report above-average posttraumatic stress symptoms (PTS).
The main questions it aims to answer are:
- How feasible do firefighter participants rate the study procedures on the Feasibility of Intervention Measure?
- How do firefighter participants rate the acceptability of the study procedures (Acceptability of Intervention Measure) and the appropriateness of the tAN device (Intervention Appropriateness Measure)?
Researchers will compare an active tAN condition (receiving therapeutic stimulation from the Sparrow device) to an active sham condition (receiving stimulation below a therapeutic level) to see if the intervention reduces PTS symptom severity and heavy drinking events, and to evaluate the clinical effects on insomnia, mental health symptoms, and quality of life.
Participants will:
- Use the Sparrow device for at least 1 hour/day for 5 days/week throughout a 4-week treatment phase.
- Complete daily measures of traumatic event exposure, PTS symptom severity, alcohol use, and trauma-related drinking motivations.
- Complete audio journals capturing their experience with symptoms and the device.
- Wear sensors to record heart rate, heart rate variability, and sleep data throughout the intervention phase.
Complete assessments immediately following treatment (Week 4) and one month later (Week 8).
Detailed description
The investigators' goal is to evaluate the feasibility, acceptability, and appropriateness of a transcutaneous auricular neurostimulation (tAN) protocol for firefighters with alcohol use disorder (AUD) and co-occurring posttraumatic stress (PTS) symptoms. Firefighters are repeatedly exposed to potentially traumatic events, and many experience PTS symptoms as a result. Over 50% of firefighters report past-month heavy alcohol use, and many use alcohol to "self-medicate" symptoms of hyperarousal, intense negative affect, and insomnia that follow traumatic events. tAN, a patient-administered intervention that delivers electrical stimulation to branches of the vagus and trigeminal nerves, has shown promise for alleviating symptoms of PTS and opioid withdrawal. However, its effects have yet to be tested in a sample of firefighters with AUD and co-occurring PTS symptoms. Within this highly impacted population, providing a culturally informed tAN intervention promises to reduce the PTS symptoms driving heavy alcohol use. Study results, utilizing the ear-worn Sparrow device, will inform a revised trial protocol and an FDA pre-submission to support a PTS/AUD indication. In summary, the investigators will examine whether the study protocol is feasible and whether active tAN provides preliminary evidence of reducing PTS symptoms and heavy drinking events compared to an active sham.
Design: The investigators will randomize 20 active-duty firefighters who engage in heavy drinking and report at least moderate PTS symptoms to receive: 1) active tAN or 2) active sham tAN. tAN is administered via the Sparrow device for at least 1 hour per day, 5 days per week, throughout a 4-week treatment phase. Assessments will be collected at Baseline (Week 0), Interim (Week 2), Post-treatment (Week 4), and 1-month follow-up (Week 8), alongside daily ecological momentary assessments and audio journals. The primary outcome will be posttreatment ratings on the Feasibility of Intervention Measure (FIM). Secondary outcomes include ratings of protocol acceptability (Acceptability of Intervention Measure; AIM) and device appropriateness (Intervention Appropriateness Measure; IAM). Exploratory clinical outcomes include the PTSD Checklist for DSM-5 (PCL-5) and heavy drinking events. Biomarker and ecological momentary assessment (EMA) analysis will examine the dynamic relationships between neurostimulation, autonomic arousal (heart rate, heart rate variability), sleep, trauma exposure, and alcohol motives.
Aim (1): Evaluate the feasibility, acceptability, and appropriateness of the study protocol and Sparrow intervention for a firefighter population with AUD and co-occurring PTS symptoms.
Hypothesis 1a: The protocol and intervention will be feasible, acceptable, and appropriate, as indicated by mean scores of 4 or greater on the FIM, AIM, and IAM.
Hypothesis 1b: The trial will meet feasibility benchmarks, including a dropout rate ≤30%, ≥80% device adherence, >50% EMA completion, and ≥80% blinding effectiveness.
Exploratory Aim (1): Assess whether the results provide preliminary support for the efficacy of the active tAN device in reducing PTS symptoms and heavy drinking events compared to sham tAN.
Exploratory Hypothesis (1): Active tAN will result in larger mean pre-post reductions and a higher percentage of clinically meaningful change in PCL-5 total scores and heavy drinking events compared to active sham tAN.
Exploratory Aim (2): Develop longitudinal data analysis strategies to examine dynamic relationships between participants' duty status, ongoing trauma exposure, PTS symptoms, alcohol use/motives, autonomic arousal, sleep patterns, and device usage.
The long-term objective of this feasibility pilot is to use the data to validate the FDA clearance strategy, inform revisions to the study protocol, and support an R01 application for a fully powered Phase II RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Firefighters are randomly assigned to receive active tAN or active Sham for the treatment phase (4 weeks).
| Arm | Type | Receives |
|---|---|---|
| Active tAN | Experimental | Device: Transcutaneous auricular neurostimulation (tAN)Transcutaneous auricular neurostimulation (tAN) applied for at least 1 hour per day, for at least 5 days per week, for at 4 week treatment phase. Frequency: 25 Hz on ABVN region, 100Hz on ATN region; pulse width: 250 µs; duty cycle: 5 minutes on, 10 seconds off. |
| Active Sham | Sham comparator | Device: Active ShamSame research device as the Active tAN condition, but programmed to deliver perceptible but subtherapeutic stimulation. Frequency: 1 Hz on outer region (ATN), Pulse width: up to 250 µs, Duty cycle: 1 minute on, 5 minutes off. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Active-duty firefighter aged 18 to 64 years old.
- Endorse at least one heavy drinking event within the past month based on sex-assigned-at-birth thresholds (males: 5+ standard drinks on a single day and/or 15+ over 7 days; females: 4+ standard drinks on a single day and/or 8+ over 7 days).
- Meet DSM-5 criteria for mild, moderate, or severe alcohol use disorder. Report at least moderate posttraumatic stress (PTS) symptoms, defined as a PTSD Checklist for DSM-5 (PCL-5) score of 20 or greater.
- Willing to attend research visits, complete EMA measurements, use the study device, and provide informed consent in English.
Key exclusion criteria (9 listed)
- Currently engaged in evidence-based PTSD psychotherapy or AUD-focused counseling at the time of randomization, or has experienced a past-month change in PTSD- or AUD-relevant medication.
- High risk for moderate to severe alcohol withdrawal syndrome, indicated by a Prediction of Alcohol Withdrawal Severity Scale (PAWSS) score of 4 or greater.
- Unmedicated psychotic disorder or unmedicated bipolar disorder with a manic episode in the past month.
- History of epileptic seizures, neurological diseases, or traumatic brain injury with lasting effects.
- Current evidence of an uncontrolled and/or clinically significant medical or psychiatric condition precluding device-related research participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous auricular neurostimulation (tAN)Also: Sparrow LinkThe research version of Spark's Sparrow Ascent for vagus and trigeminal nerve stimulation provided through a disposable earpiece that attaches to the ear. The device allows the participant to self-administer stimulation when they choose. | Device | Active tAN |
| Active ShamAlso: Sparrow LinkSame research device as the active tAN condition, but programmed with active sham parameters such that the stimulation is sufficient to be felt on the skin, but subtherapeutic. | Device | Active Sham |
Primary outcome
Protocol Feasibility as Assessed by the Feasibility of Intervention Measure (FIM)
Time frame: Post-treatment (Week 4) and 1-month follow-up (Week 8)
The FIM is a 4-item self-report questionnaire assessing the extent to which participants agree that the study protocol is feasible to implement. Items are rated on a 5-point Likert scale ranging from 1 ("Completely disagree") to 5 ("Completely agree"). Scores are calculated as an average across items (ranging from 1 to 5), with higher scores indicating greater feasibility. Feasibility success is predefined as a mean score of at least 4.
6 secondary outcomes
Protocol Acceptability as Assessed by the Acceptability of Intervention Measure (AIM)
Time frame: Post-treatment (Week 4) and 1-month follow-up (Week 8)
Device Appropriateness as Assessed by the Intervention Appropriateness Measure (IAM)
Time frame: Post-treatment (Week 4) and 1-month follow-up (Week 8)
Protocol Feasibility: Participant Retention Rate
Time frame: Baseline (Week 0) through Week 4
Protocol Feasibility: Sparrow Device Adherence Rate
Time frame: Daily throughout the 4-week treatment phase (Weeks 1-4)
Protocol Feasibility: Ecological Momentary Assessment (EMA) Completion Rate
Time frame: Daily throughout the 4-week treatment phase (Weeks 1 through 4)
Blinding Effectiveness Assessment
Time frame: Post-treatment (Week 4)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes. All de-identified human subjects data will be submitted to the NIAAADA. Proprietary Spark Biomedical, Inc. tAN protocols will not be shared. We will share non-proprietary syntax and software solutions created to publish findings from this project. We will upload supporting documents (e.g., study protocols, assessment schedules, data dictionaries, and analytic algorithms used for publications) to the NDA to facilitate reuse.
Related trials for Posttraumatic Stress Symptoms
Not yet recruitingPhase 2
Post-traumatic Estradiol Administration and Care Evaluation (PEACE)
Chronic Musculoskeletal Pain, Sexual Assault
Not yet recruiting
A Mobile Health Intervention to Improve Psychosocial Functioning in Veterans With Posttraumatic Stress Disorder and Depression Symptoms
Psychosocial Functioning, Stress Disorders, Post-Traumatic
Recruiting
Deep Brain Reorienting for Posttraumatic Stress Disorder
Posttraumatic Stress Disorder (PTSD), Posttraumatic Stress Symptom
Not yet recruiting
CHW-Enhanced Trauma Recovery
Traumatic Injury, Posttraumatic Stress Disorder
Not yet recruiting
Treatment of Fibromyalgia and PTSD With Live and Inactive Vagus Nerve Stimulation With PEPC
Fibromyalgia (FM), Posttraumatic Stress Disorder (PTSD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous auricular neurostimulation (tAN) in people with Posttraumatic Stress Symptoms and Heavy Alcoholic Consumption, run by University of Cincinnati.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Principal Investigator (513-287-9517, ucptsdstudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protocol Feasibility as Assessed by the Feasibility of Intervention Measure (FIM) (time frame: Post-treatment (Week 4) and 1-month follow-up (Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.