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Zapping stress: wearable device tested for first responder burnout

NCT ID NCT07109349

Symptom relief Sponsor: Spark Biomedical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tests a wearable device called Sparrow Link that gently stimulates nerves in the ear to improve mental wellness in first responders. Thirty participants will use the device daily for 28 days and fill out questionnaires about stress, anxiety, sleep, and burnout over 8 weeks. The goal is to see if this non-invasive approach can ease mental fatigue and build resilience.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sparrow Link device (transcutaneous auricular neurostimulation)
What this could lead to
If it works, this could offer a drug-free, at-home option to help first responders manage daily stress and mental fatigue.
What could go wrong
This is a small, early pilot trial with no placebo group, so results may not be reliable or generalizable. The device may not reduce stress more than doing nothing.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Mental Fatigue Stress, Psychological

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mental fatigue Mental stress

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Spark Biomedical - DECENTRALIZED STUDY

    RECRUITING

    Dallas, Texas, 75252, United States

    Contact Email: •••••@•••••

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