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tAN for First Responders

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Minor Trial completed Show 6 more changesShow less
    • Final enrollment: 23 participants (planned 30)
    • Study completion date changed from estimate of Jul 20, 2026 to Sep 8, 2026
    • Primary completion date changed from estimate of Jul 10, 2026 to Aug 6, 2026
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Site details revised
  2. Minor Re-verified, no change to tracked fieldsv7
  3. Notable Enrollment reduced: 50 → 30 participantsv6
  4. Minor Primary completion date: Feb 10, 2026 to Jul 10, 2026
    • Study completion date: Feb 20, 2026 to Jul 20, 2026
    v5
  5. Minor Re-verified, no change to tracked fieldsv4
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  1. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Feb 14, 2026 to Feb 10, 2026
    • Study completion date: Feb 28, 2026 to Feb 20, 2026
    • Start date changed from estimate of Sep 15, 2025 to Sep 10, 2025
    • Site details revised
  2. Minor Start date: Aug 18, 2025 to Sep 15, 2025v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07109349
Lead Sponsor Spark Biomedical, Inc.
Conditions
(from sponsor)
Mental Fatigue, Mental Stress
Related terms Mental Fatigue, Stress, Psychological
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov