Actively Recruiting
tAN for First Responders
Led by Spark Biomedical, Inc. · Updated on 2026-04-08
30
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
tAN for First Responders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is currently employed in a first responder position
- Age 6 18 years
- Reliable access to an internet-enabled device to complete required questionnaires
- GAD-7 score 6 5
You will not qualify if you...
- History of epileptic seizures
- History of neurologic diseases or traumatic brain injury
- Presence of devices such as pacemakers, cochlear prostheses or implants, or neurostimulators
- Abnormal left ear anatomy or current ear infection
- Auditory impairment of the left ear including ruptured eardrum, deafness, or tinnitus
- Currently enrolled in another interventional trial
- Women of childbearing potential not using adequate contraception
- Females who are pregnant or lactating
- Any other significant disease or disorder that may increase risk, affect trial results, or participation ability as judged by the Investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Spark Biomedical - DECENTRALIZED STUDY
Dallas, Texas, United States, 75252
Actively Recruiting
Research Team
K
Kimi Harada
CONTACT
C
Caroline Benner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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