Recruiting

tAN

Sponsor:

Spark Biomedical, Inc.

Code:

NCT07109349

Conditions

Mental Fatigue

Mental Stress

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sparrow Link

Study Details

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 Fatigue

Mental Stress

Study ID

NCT07109349

Start date

Sep 10, 2025

Status verified date

Jun, 2026

Completion date

Jul 20, 2026

Anticipated

Primary completion date

Jul 10, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

1. Participant has a history of epileptic seizures
2. Participant has a history of neurologic diseases or traumatic brain injury
3. Participant has presence of devices (e.g., pacemakers, cochlear prostheses or implants, neurostimulators)
4. Participant has abnormal left ear anatomy or ear infection present
5. Participant has auditory impairment of the left ear (ruptured eardrum, deafness, tinnitus, etc.)
6. Participant is currently enrolled in another interventional trial
7. Women of childbearing potential, not using adequate contraception as per the investigator's judgement
8. Females who are pregnant or lactating
9. 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active tAN

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.

Interventions

Sparrow Link

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.

Primary outcome measure

  • GAD-7 [ Time Frame: Screening, Day 0, Day 14, Day 28, Day 42, Day 56 ]

Central Contacts and Locations

Central contacts

Kimi Harada

210-404-4162clinicaltrials@sparkbiomedical.com

Caroline Benner

clinicaltrials@sparkbiomedical.com

Locations

Spark Biomedical - DECENTRALIZED STUDY

Recruiting

Dallas, Texas, United States, 75252

Contacts

Kimi Harada

210-404-4162clinicaltrials@sparkbiomedical.com

More Information

Sponsor

Spark Biomedical, Inc.

Last update posted

Jun 2, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Spark Biomedical, Inc. on 2026-06-02.