An interventional study of Transcutaneous auricular neurostimulation (tAN) and Active Sham in Posttraumatic Stress Symptoms, Heavy Alcoholic Consumption and Alcohol Use Disorder (AUD), sponsored by University of Cincinnati. Not yet recruiting. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by University of Cincinnati · Not applicable, Interventional, and Treatment
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:
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:
Complete assessments immediately following treatment (Week 4) and one month later (Week 8).
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.
1,634 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's planned enrollment of 20 is below the median of 88 across 1,395 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →University of Cincinnati is the lead sponsor of 324 studies on the registry; 42 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 15 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: Transcutaneous auricular neurostimulation (tAN)
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.
Device: Active Sham
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.
Also known as: 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.
Also known as: Sparrow Link
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.
Time frame: Post-treatment (Week 4) and 1-month follow-up (Week 8)
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Post-treatment (Week 4)
Posttraumatic Stress Disorder Symptom Severity (PCL-5)
Mean pre-post change in PTSD Checklist for DSM-5 (PCL-5) total scores, as well as the proportion of participants achieving clinically meaningful symptom reduction (at least 30% reduction from baseline). The PCL-5 comprises 20 items rated from 0 ("Not at all") to 4 ("Extremely"), yielding total symptom severity scores from 0 to 80, where lower scores indicate lower PTS symptom severity.
Time frame: Baseline (Week 0), Interim (Week 2), Post-treatment (Week 4), and 1-month follow-up (Week 8)
Heavy Drinking Events
Change in the frequency of heavy drinking events using sex-assigned-at-birth thresholds (defined as 5+ standard drinks/day or 15+ drinks/week for males; 4+ drinks/day or 8+ drinks/week for females), measured via the Timeline Follow-back (TLFB). Also evaluated as the percentage of participants achieving a clinically meaningful reduction (50% or greater reduction in heavy drinking events).
Time frame: Baseline (Week 0), Interim (Week 2), Post-treatment (Week 4), and 1-month follow-up (Week 8)
Clinician-Assessed PTSD Severity (CAPS-5)
Evaluated using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), measuring past-week PTSD diagnostic status and continuous symptom severity, where lower scores indicate reduced symptom severity.
Time frame: Baseline (Week 0), Post-treatment (Week 4), and 1-month follow-up (Week 8)
Insomnia Symptom Severity (ISI)
Total scores on the Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia symptoms. Scores range from 0 to 28, with lower scores indicating less severe insomnia.
Time frame: Baseline (Week 0), Interim (Week 2), Post-treatment (Week 4), and 1-month follow-up (Week 8)
Depression Symptom Severity (PHQ-9)
Total score on the Patient Health Questionnaire-9 (PHQ-9), assessing depressive symptom severity over the past 2 weeks. Scores range from 0 to 27, with lower scores indicating lower symptom severity.
Time frame: Baseline (Week 0), Interim (Week 2), Post-treatment (Week 4), and 1-month follow-up (Week 8)
Generalized Anxiety Symptom Severity (GAD-7)
Total score on the Generalized Anxiety Disorder-7 (GAD-7) scale, assessing anxiety symptom severity over the past 2 weeks. Scores range from 0 to 21, with lower scores indicating less anxiety.
Time frame: Baseline (Week 0), Interim (Week 2), Post-treatment (Week 4), and 1-month follow-up (Week 8)
Quality of Life (WHOQOL-BREF US)
Domain and overall scores on the WHO Quality of Life Brief - US Version, assessing physical, psychological, social, and environmental wellbeing, where higher scores reflect higher quality of life.
Time frame: Baseline (Week 0), Interim (Week 2), Post-treatment (Week 4), and 1-month follow-up (Week 8)
Psychosocial Functioning Impairment (B-IPF)
Total score on the Brief Inventory of Psychosocial Functioning, assessing functional impairment attributable to posttraumatic stress symptoms across interpersonal, work, and routine domains. Lower scores reflect less impairment.
Time frame: Baseline (Week 0), Post-treatment (Week 4), and 1-month follow-up (Week 8)
Mean Resting Heart Rate
The average heart rate, measured in beats per minute.
Time frame: Continuously daily throughout the 4-week treatment phase (Weeks 1 through 4)
Mean Heart Rate Variability (HRV)
The average heart rate variability, measured in milliseconds (ms).
Time frame: Continuously daily throughout the 4-week treatment phase (Weeks 1 through 4)
Mean Total Sleep Time per Night
The average total duration of sleep per night, measured in minutes.
Time frame: Continuously daily throughout the 4-week treatment phase (Weeks 1 through 4)
Mean Number of Nighttime Awakenings
The average count of distinct awakening events during the primary sleep period per night.
Time frame: Continuously daily throughout the 4-week treatment phase (Weeks 1 through 4)
Qualitative Implementation Feedback (Study Experience Interview)
Rapid turnaround qualitative data reduction of semi-structured interviews evaluating participant perceptions of the device, EMA procedures, barriers, facilitators, and recommended modifications to inform protocol refinements.
Time frame: Post-treatment (Week 4) and 1-month follow-up (Week 8)
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be submitted biannually (beginning October 1, 2027) per NIAAADA terms. De-identified data will be shared according to the default NIAAADA schedule and retained indefinitely.
Access criteria: Access to study data and supporting materials will be controlled and managed securely by the NDA Data Access Committee.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.