NCT06390267

Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Spark Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years – 41 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to test the effects of transcutaneous auricular neurostimulation (tAN) in treating or preventing performance degradation after an acute stressor.

Detailed description

This study is designed as a randomized, double-blind, sham-controlled trial. Sixty healthy, able-bodied participants will be randomized 1:1:2:2 into one of four experimental groups: Group 1: Active tAN for prophylactic treatment prior to acute stress exposure (N=10) Group 2: Sham stimulation for prophylactic treatment prior to acute stress exposure (N=10) Group 3: Active tAN for acute treatment during acute stress exposure (N=20) Group 4: Sham stimulation for acute treatment during acute stress exposure (N=20) Participants will complete a baseline performance of three tasks. tAN treatment will then be administered prior to or during an acute stress test. Participants will complete the same three tasks preformed at baseline. In addition to the tAN therapy earpiece, subjects will have biosensors attached to them to collect biomarker information.

Conditions

• Acute Stress Reaction
• Cognitive Performance

Interventions

Type	Name	Description
DEVICE	Sparrow Hawk (Active)	Wearable, battery-operated, device designed to transcutaneously stimulate nerves on and/or around the auricle. The device will be used to deliver tAN sessions of active (prophylactic or acute) therapy according to the participant's randomization group.
DEVICE	Sparrow Hawk (Sham)	Wearable, battery-operated, device designed to transcutaneously stimulate nerves on and/or around the auricle. The device will be used to deliver tAN sessions of sham (prophylactic or acute) therapy according to the participant's randomization group.

Timeline

• Start date: 2024-11-26
• Primary completion: 2025-06-18
• Completion: 2025-06-18
• First posted: 2024-04-30
• Last updated: 2025-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study