Self-administered Neurostimulation Intervention for Firefighter Traumatic Stress to Reduce Alcohol Use: Pilot Study
SANI-T
Developing and Evaluating a Firefighter Self-administered Neurostimulation Intervention for Traumatic Stress to Reduce Alcohol Use
1 other identifier
interventional
20
0 countries
N/A
Brief 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). 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2027
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2026
CompletedFirst Posted
Study publicly available on registry
October 9, 2026
CompletedStudy Start
First participant enrolled
September 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
Study Completion
Last participant's last visit for all outcomes
June 30, 2028
October 9, 2026
October 1, 2026
8 months
October 1, 2026
October 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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)
Post-treatment (Week 4) and 1-month follow-up (Week 8)
Device Appropriateness as Assessed by the Intervention Appropriateness Measure (IAM)
Post-treatment (Week 4) and 1-month follow-up (Week 8)
Protocol Feasibility: Participant Retention Rate
Baseline (Week 0) through Week 4
Protocol Feasibility: Sparrow Device Adherence Rate
Daily throughout the 4-week treatment phase (Weeks 1-4)
Protocol Feasibility: Ecological Momentary Assessment (EMA) Completion Rate
Daily throughout the 4-week treatment phase (Weeks 1 through 4)
- +1 more secondary outcomes
Other Outcomes (13)
Posttraumatic Stress Disorder Symptom Severity (PCL-5)
Baseline (Week 0), Interim (Week 2), Post-treatment (Week 4), and 1-month follow-up (Week 8)
Heavy Drinking Events
Baseline (Week 0), Interim (Week 2), Post-treatment (Week 4), and 1-month follow-up (Week 8)
Clinician-Assessed PTSD Severity (CAPS-5)
Baseline (Week 0), Post-treatment (Week 4), and 1-month follow-up (Week 8)
- +10 more other outcomes
Study Arms (2)
Active tAN
EXPERIMENTALTranscutaneous 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 COMPARATORSame 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- All are blind except for the study team member who programs the device for the assigned condition and is not involved in assessing outcomes.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 1, 2026
First Posted
October 9, 2026
Study Start (Estimated)
September 1, 2027
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
October 9, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
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.