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NCT07109349 · ClinicalTrials.gov registry record · NA
tAN for First Responders
A NA study of Mental Stress and Mental Fatigue, sponsored by Spark Biomedical.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT07109349 is a NA study of Mental Stress and Mental Fatigue that is actively recruiting participants, run by Spark Biomedical. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state.
The verdict
NCT07109349, a NA study of Mental Stress and Mental Fatigue, is actively recruiting participants, sponsored by Spark Biomedical.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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 Coordi
Conditions Studied
Interventions
- DEVICE Sparrow Link
Study Locations (1)
Texas
- Spark Biomedical - DECENTRALIZED STUDY - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-09-10 |
| Est. Completion | 2026-07-20 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07109349
The ClinicalTrials.gov registry entry for NCT07109349 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spark Biomedical, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Mental Stress appearing as the primary indexed condition, and to 1 intervention - of which Sparrow Link is the first listed.
NCT07109349 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT07109349 about?
NCT07109349 is a clinical study titled "tAN for First Responders". 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 ...
What is the current status of trial NCT07109349?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2025-09-10. Estimated completion is 2026-07-20.
What conditions does trial NCT07109349 study?
This clinical trial studies the following conditions: Mental Stress, Mental Fatigue.
What interventions are being tested in trial NCT07109349?
The interventions under investigation include: Sparrow Link (DEVICE).
Who is sponsoring clinical trial NCT07109349?
This trial is sponsored by Spark Biomedical, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07109349 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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