tAN for First Responders

🩺 Protocol Summary

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.

Primary Research Facility: Spark Biomedical - DECENTRALIZED STUDY (Dallas, Texas)

Review these 3 basic logistical and protocol criteria extracted from the public NIH record. (This is a preliminary logistical checklist, not an official clinical eligibility determination).

Diagnosed with, undergoing evaluation for, or seeking treatment related to Mental Fatigue?

🔍 Study Population / Focus Area (Source: Protocol Primary Condition)

Aged 18 Years or older?

🔍 Protocol Specified Minimum Age: 18 Years

Able to attend required clinic visits at Spark Biomedical - DECENTRALIZED STUDY (Dallas, Texas)?

🔍 Logistical Requirement: Site at Spark Biomedical - DECENTRALIZED STUDY

📍 Primary Site Map

Site: Spark Biomedical - DECENTRALIZED STUDY — Dallas, Texas

💰 Clinical Trial Costs & Insurance Coverage

Coverage for clinical trial participation varies depending on your health insurance policy, state legislation, and whether specific procedures are investigational research or routine medical care. Under federal law (Affordable Care Act § 2709), health insurers generally cannot drop coverage or refuse to pay for routine patient care costs incurred in approved clinical trials.

💡 Always ask the study coordinator for the trial's official Informed Consent Form, which outlines all sponsor-funded research items versus procedures billed to your insurance.