tAN for First Responders

Recruiting now · Not applicable

Conditions studied: Mental Fatigue, Mental Stress

In brief

This study is designed as an open label, single arm, decentralized clinical study in which first responders will receive transcutaneous auricular neurostimulation (tAN), which targets the auricular branch of the vagus nerve (ABVN) via the mastoid and the auriculotemporal nerve (ATN) anterior to the tragus. Participants will be enrolled in the study over the course of eight weeks (56 days). Participants will respond to daily and weekly questionnaires regarding mood, stress, sleep, energy/fatigue, and burnout. Each week, participants will complete consolidated online questionnaires (intended to last no longer than 15 minutes) comprised of the Perceived Stress Short-Form (PSS-4), Well-Being Index (WHO-5), Mini-Z Burnout (5-item), PROMS Sleep Disturbance (PROMIS-SD), GAD-7 (every 2 weeks), and Perceived Stress (PSS-10; monthly). The PSS-10 will replace the PSS-4 on Days 0, 28, and 56. No tAN treatment will be delivered during the Baseline Period (days between Study Introduction and Day 0). Participants will complete the weekly set of questionnaires ("Weekly Questionnaires") on Day 0. Participants will be recommended to complete the daily set of questionnaires ("Daily Questionnaires ") on the other days of the Baseline Period. On Days 1 - 28, participants will self-administer one session of one to two hours of tAN therapy each day. Participants will be recommended to complete the daily tAN session post-shift prior to sleep. Weekly Questionnaires will be completed by participants on Study Days 0, 7, 14, 21, 28, 35, 42, 49, and 56. Participants will be recommended to complete Daily Questionnaires on all other study days, up to Day 28. Daily Questionnaires will not be required to be completed by participants. Daily tAN sessions and Daily Questionnaires will cease after Day 28. Participants will complete a Study Satisfaction Questionnaire with the Weekly Questionnaires on Day 56. Following Day 56, participants will schedule a Study Exit Interview with the Research Coordinator.

Key facts

Study ID: NCT07109349
Run by: Spark Biomedical, Inc.
People needed: 30
Starts: 2025-09-10
Expected to finish: 2026-07-20
Last updated by the study team: 2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Participant has a history of epileptic seizures
Participant has a history of neurologic diseases or traumatic brain injury
Participant has presence of devices (e.g., pacemakers, cochlear prostheses or implants, neurostimulators)
Participant has abnormal left ear anatomy or ear infection present
Participant has auditory impairment of the left ear (ruptured eardrum, deafness, tinnitus, etc.)
Participant is currently enrolled in another interventional trial
Women of childbearing potential, not using adequate contraception as per the investigator's judgement
Females who are pregnant or lactating
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 it is running

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

Full record on ClinicalTrials.gov

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