Clinical Data:

• Data from a small randomized control trial supports the effectiveness of vagal nerve stimulation in reducing stress and anxiety, as demonstrated by increased parasympathetic activity and improvements in heart rate variability.
• Vagal nerve stimulation is an FDA-approved therapy for various conditions, and broader evidence suggests effectiveness of vagal nerve stimulation in stress reduction.

Mechanism:

• Pulsetto device utilizes non-invasive vagus nerve stimulation to activate the parasympathetic nervous system. Stimulation of the vagus nerve promotes relaxation, reduces stress and anxiety, and improves heart rate variability.
• Pulsetto Lite (companion mobile application) synchronizes with the device and monitors progress related to sleep, anxiety, and stress.
• Pulsetto's anxiety program offers practical tasks, exercises, and strategies to help individuals manage anxiety, reduce stress, regain control, and develop effective routines to cope with triggers. 

Safety and Side Effects:

• Potential side effects include dizziness, local pain, twitching, headaches, tingling, nausea, , decreased heart rate, and increased heart rate variability.
• Users are advised to consult with their healthcare provider before using Pulsetto or any similar devices.

Patient Eligibility:

• Not to be used in patients with history of vagotomy (bilateral or left cervical)
• Not to be used by patients when undergoing diathermy

Cost:

• Device: $239
• Anxiety program: $0.39/month (lifetime access included with device purchase)
• Mobile application: Pulsetto Lite - Free to download on App Store (Apple) and Google Play Store (Android)