Efficacy and Accuracy of an AI-Driven Sleep Earbud for Chronic Insomnia

This study evaluates a new smart sleep earbud designed to help adults suffering from chronic insomnia. The device uses artificial intelligence (AI) to track a user's real-time heart rate and movement through the ear canal, automatically adjusting soothing music parameters to help the user fall asleep faster and achieve deeper sleep. Participants will spend three consecutive nights in a hospital sleep laboratory. The first night serves as a baseline screening using medical-grade sleep tracking (polysomnography) to rule out other hidden sleep conditions like sleep apnea. On the second and third nights, participants will test two different audio options in a randomized order: the AI-driven adaptive music and standard, non-adjusting music. Researchers will compare the earbud's internal sensor data against the hospital's clinical equipment to verify the earbud's tracking accuracy, and participants will complete brief touch-screen brain function tests each morning. Following the lab phase, participants will continue using the earbuds in their natural home environment for two weeks before a final check-up. The goal is to determine if personalized, AI-adjusted sound therapy can effectively treat insomnia symptoms and if a consumer ear-worn device can monitor sleep architecture as accurately as a clinical hospital system.