Ear-based nerve stimulation (tAN) to help first responders with stress and fatigue

Effect of Transcutaneous Auricular Neurostimulation on Mental Wellness and Resiliency for First Responders: A Pilot Trial

This study will try a noninvasive ear nerve stimulation device (tAN) in first responders with stress or anxiety to see if it improves mood, sleep, energy, and burnout over eight weeks.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Spark Biomedical, Inc. (industry)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT07109349 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-arm, decentralized study enrolling first responders for a 56-day period during which participants will use transcutaneous auricular neurostimulation (tAN) targeting the auricular branch of the vagus nerve and the auriculotemporal nerve. No stimulation is delivered during the baseline period; participants then receive tAN and complete daily and weekly online questionnaires about mood, stress, sleep, energy/fatigue, and burnout. Standardized instruments include PSS-4/PSS-10, WHO-5, Mini-Z Burnout, PROMIS Sleep Disturbance, and GAD-7 at prespecified intervals. All data collection is remote and consolidated questionnaires are designed to take no longer than about 15 minutes per week.

Who should consider this trial

Good fit: Ideal candidates are first responders aged 18 or older with at least mild anxiety (GAD-7 ≥ 5), reliable internet access, and no contraindicating neurologic or implantable device conditions.

Not a fit: People with a history of seizures, neurologic disease or traumatic brain injury, implanted electronic devices, significant left-ear anatomic problems or infection, pregnant or lactating women, or those in other interventional trials are excluded and may not benefit from this intervention.

Why it matters

Potential benefit: If effective, the device could reduce perceived stress and burnout and improve sleep and energy for first responders.

How similar studies have performed: Related transcutaneous auricular and vagus nerve stimulation approaches have shown promising but mixed results in small trials, so this builds on existing but not definitive evidence.

Eligibility criteria

Inclusion Criteria:

1. Participant is currently employed in a first responder position
2. Age ≥ 18 years
3. Reliable access to an internet-enabled device to complete required questionnaires
4. GAD-7 score ≥ 5

Exclusion Criteria:

1. Participant has a history of epileptic seizures
2. Participant has a history of neurologic diseases or traumatic brain injury
3. Participant has presence of devices (e.g., pacemakers, cochlear prostheses or implants, neurostimulators)
4. Participant has abnormal left ear anatomy or ear infection present
5. Participant has auditory impairment of the left ear (ruptured eardrum, deafness, tinnitus, etc.)
6. Participant is currently enrolled in another interventional trial
7. Women of childbearing potential, not using adequate contraception as per the investigator's judgement
8. Females who are pregnant or lactating
9. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Where this trial is running

Dallas, Texas

• Spark Biomedical - DECENTRALIZED STUDY — Dallas, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Navid Khodaparast, PhD — Spark Biomedical, Inc.
• Study coordinator: Kimi Harada

Conditions: Mental Fatigue, Mental Stress, Mental resilience, tAN, Transcutaneous Auricular Neurostimulation, Vagus nerve stimulation, Neurostimulation, First responders