tAN for First Responders

Browse trials for

• Mental Fatigue 154
• Stress, Psychological 781

Keywords

• Mental resilience
• tAN
• Transcutaneous Auricular Neurostimulation
• Vagus nerve stimulation
• Neurostimulation
• First responders
• taVNS
• Police officer

Study arms

• Experimental
  Active tAN

  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.

  Device: Sparrow Link

Interventions

• DeviceSparrow 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.

  Also known as: Transcutaneous Auricular Neurostimulation

Primary outcomes

1. 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.

   Time frame: Screening, Day 0, Day 14, Day 28, Day 42, Day 56

Secondary outcomes

1. 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.

   Time frame: Weekly throughout enrollment beginning Day 0 through Day 56)

2. 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.

   Time frame: Weekly throughout enrollment beginning Day 0 through Day 56)

3. 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.

   Time frame: Weekly throughout enrollment beginning Day 0 through Day 56)

4. 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.

   Time frame: Weekly throughout enrollment beginning Day 0 through Day 56)