tAN for First Responders

NCT07109349 | Recruiting FDA Device

• 1 other identifier: SBM-MRES-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mental Stress; Mental Fatigue

Keywords

Mental resilience; tAN; Transcutaneous Auricular Neurostimulation; Vagus nerve stimulation; Neurostimulation; First responders; taVNS; Police officer

Outcome Measures

Primary Outcomes (1)

• GAD-7

  The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research. The questionnaire consists of 7 questions in which participants are asked to rate each item on a 0 (not at all) to 3 (nearly every day). GAD-7 total score for the seven items ranges from 0 to 21 where 0-4 represents minimal anxiety, 5-9 represents mild anxiety, 10-14 represents moderate anxiety and 15-21 represent severe anxiety.

  Screening, Day 0, Day 14, Day 28, Day 42, Day 56

Secondary Outcomes (4)

• Perceived Stress Scale (PSS-4, PSS-10)

  Weekly throughout enrollment beginning Day 0 through Day 56)

• PROMIS Sleep Disturbance

  Weekly throughout enrollment beginning Day 0 through Day 56)

• WHO-5 Well-Being Index

  Weekly throughout enrollment beginning Day 0 through Day 56)

• Mini-Z Burnout Survey

  Weekly throughout enrollment beginning Day 0 through Day 56)

Study Arms (1)

Active tAN

EXPERIMENTAL

First responders will self-administer once-daily active tAN sessions for 1-2 hours for 28 days. Participants will complete daily and weekly assessments to evaluate levels of stress, mood, energy/fatigue, sleep quality , and burnout. Daily assessments and tAN sessions will cease after Day 28. Participants will continue to complete weekly assessments until Day 56.

Device: Sparrow Link

Interventions

Sparrow Link DEVICE

Sparrow Link will be using the components of the Sparrow Ascent device: (FDA-cleared K230796) a wearable, battery-operated, neurostimulation system designed to transcutaneously stimulate nerves on and/or around the auricle. Participants will self-administer daily active tAN sessions on Days 1 - 28.

Also known as: Transcutaneous Auricular Neurostimulation

Active tAN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Spark Biomedical, Inc.: lead

Study Sites (1)

Spark Biomedical - DECENTRALIZED STUDY

Dallas, Texas, 75252, United States

RECRUITING

MeSH Terms

Conditions

Mental Fatigue; Stress, Psychological

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Navid Khodaparast, PhD

  Spark Biomedical, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimi Harada

CONTACT

210-404-4162; clinicaltrials@sparkbiomedical.com

Caroline Benner

CONTACT

clinicaltrials@sparkbiomedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 7, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): July 10, 2026
• Study Completion (Estimated): July 20, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)