tAN for First Responders
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sparrow Link.
- Who it may be relevant to
- Registry conditions: Mental Fatigue, Mental Stress. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Transcutaneous Auricular Neurostimulation on Mental Wellness and Resiliency for First Responders: A Pilot Trial
Overview
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.
Interventions
- Device 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 measures
- GAD-7 [Time frame: Screening, Day 0, Day 14, Day 28, Day 42, Day 56]
Secondary outcome measures (4)
- 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)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Spark Biomedical - DECENTRALIZED STUDY — Dallas
Identifiers
NCT: NCT07109349 · SBM-MRES-01