Clinical Trial

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

Active, Not Recruiting
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Summary
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.
Trial Details
NCT Number NCT07744581
Lead Sponsor The Chinese University of Hong Kong, Shenzhen
Collaborators: Chinese University of Hong Kong
Conditions Insomnia, Insomnia Chronic, Insomnia Disorders, Sleep Wake Disorders
Enrollment 25 participants
Start Date 2026-07-01
Primary Completion 2026-10-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-04