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NOT YET RECRUITING
NCT07868055
NA

Self-administered Neurostimulation Intervention for Firefighter Traumatic Stress to Reduce Alcohol Use: Pilot Study

Sponsor: University of Cincinnati

View on ClinicalTrials.gov

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).

Official title: Developing and Evaluating a Firefighter Self-administered Neurostimulation Intervention for Traumatic Stress to Reduce Alcohol Use

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2027-09-01

Completion Date

2028-06-30

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

DEVICE

Transcutaneous auricular neurostimulation (tAN)

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.

DEVICE

Active Sham

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.