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Study identifier: NCT07109349 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

tAN for First Responders

Condition: Mental Fatigue · Mental Stress  ·  Sponsor: Spark Biomedical, Inc.

PhaseNA
Planned participants30
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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 participant…

This description comes directly from the study's public registry record.

Talk to the study team

Kimi Harada  ·  210-404-4162  ·  clinicaltrials@sparkbiomedical.com

Caroline Benner  ·  clinicaltrials@sparkbiomedical.com

Always discuss trial participation with your own doctor first.

Locations (1)

Spark Biomedical - DECENTRALIZED STUDYDallas, Texas, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07109349