Mental FatigueNCT07109349
tAN for First Responders
A study testing Sparrow Link in people with Mental Fatigue and Mental Stress, run by Spark Biomedical, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Fatigue, Mental Stress
- What is being tested?
- Sparrow Link
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2025to 8 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Spark Biomedical - DECENTRALIZED STUDY
Dallas, Texas, 75252
About this study
Official title: Effect of Transcutaneous Auricular Neurostimulation on Mental Wellness and Resiliency for First Responders: A Pilot Trial
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.
Read more
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
- Being tested
- Sparrow Link
- Keywords
- Mental resilience, tAN, Transcutaneous Auricular Neurostimulation, Vagus nerve stimulation, Neurostimulation, First responders, taVNS, Police officer
- Medical subject headings
- Mental Fatigue, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sparrow LinkDevice
Also called Transcutaneous Auricular Neurostimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Sparrow Link |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening, Day 0, Day 14, Day 28, Day 42, Day 56
Secondary outcomes (4)
Perceived Stress Scale (PSS-4, PSS-10)
The PSS-4 is a brief version of the Perceived Stress Scale used to assess the degree to which situations in one's life are appraised as stressful. The questionnaire consists of 4 items, with participants rating each on a 0 (never) to 4 (very often) scale. Scores range from 0 to 16, with higher scores indicating greater perceived stress. The PSS-10 consists of 10 items that assess how unpredictable, uncontrollable, and overloaded respondents find their lives. Each item is rated on a 0 (never) to 4 (very often) scale. Total scores range from 0 to 40, with higher scores indicating greater perceived stress.
The PSS-10 will replace the PSS-4 on Days 0, 28, and 56.
Measured: Weekly throughout enrollment beginning Day 0 through Day 56)
PROMIS Sleep Disturbance
The PROMIS Sleep Disturbance measure evaluates self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. Participants respond to 8 items rated on a 1 (not at all) to 5 (very much) scale. Raw scores are converted to T-scores with a mean of 50 and a standard deviation of 10, where higher scores indicate greater sleep disturbance. The tool is suitable for use in clinical and research populations.
Measured: Weekly throughout enrollment beginning Day 0 through Day 56)
WHO-5 Well-Being Index
The WHO-5 is a short, validated measure of current mental well-being. The questionnaire consists of 5 positively worded items rated on a 0 (at no time) to 5 (all of the time) scale. The raw score ranges from 0 to 25 and is multiplied by 4 to yield a final score from 0 to 100, with higher scores indicating greater well-being. A score below 50 suggests reduced well-being and may indicate the need for further assessment.
Measured: Weekly throughout enrollment beginning Day 0 through Day 56)
Mini-Z Burnout Survey
The Mini-Z Burnout Survey is a brief tool for assessing burnout and job satisfaction. It includes 10 items covering emotional exhaustion, stress, satisfaction, and workload. Most items are rated on a 1 to 5 Likert scale. Higher scores on the burnout item (typically scored 1 to 5) reflect greater burnout, with a score of 3 or higher suggesting at least some level of burnout.
Measured: Weekly throughout enrollment beginning Day 0 through Day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start10 Sep 2025
- Primary completion6 Aug 2026
- Study completion8 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spark Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Navid Khodaparast, PhD, Principal investigator, Spark Biomedical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109349
- Sponsor's protocol ID
- SBM-MRES-01
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcutaneous Auricular Neurostimulation on Mental Wellness and Resiliency for First Responders: A Pilot Trial
- ClinicalTrials.gov ID
- NCT07109349
- Acronym / sponsor ID
- SBM-MRES-01
- Conditions
- Mental Fatigue, Mental Stress
- Keywords
- Mental resilience, tAN, Transcutaneous Auricular Neurostimulation, Vagus nerve stimulation, Neurostimulation, First responders, taVNS, Police officer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Spark Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 6 Aug 2026 (actual)
- Study completion
- 8 Sep 2026 (actual)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active tAN | Experimental | Device: Sparrow LinkFirst 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sparrow LinkAlso: Transcutaneous Auricular NeurostimulationSparrow 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. | Device | Active tAN |
Primary outcome
GAD-7
Time frame: Screening, Day 0, Day 14, Day 28, Day 42, Day 56
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.
4 secondary outcomes
Perceived Stress Scale (PSS-4, PSS-10)
Time frame: Weekly throughout enrollment beginning Day 0 through Day 56)
PROMIS Sleep Disturbance
Time frame: Weekly throughout enrollment beginning Day 0 through Day 56)
WHO-5 Well-Being Index
Time frame: Weekly throughout enrollment beginning Day 0 through Day 56)
Mini-Z Burnout Survey
Time frame: Weekly throughout enrollment beginning Day 0 through Day 56)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Navid Khodaparast, PhD principal investigator
Spark Biomedical, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sparrow Link in people with Mental Fatigue and Mental Stress, run by Spark Biomedical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAD-7 (time frame: Screening, Day 0, Day 14, Day 28, Day 42, Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.