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.
Inclusion Criteria
Exclusion Criteria
This study utilizes a double-masking protocol involving the participant and the investigator. Participants are blinded to the specific acoustic treatment sequence, as the user interface and appearance of the mobile application remain identical for both the AI-driven neuromodulation music and the standard sham music conditions. Investigators who administer the morning neurocognitive assessments (CANTAB), collect subjective sleep questionnaires, and analyze or score the raw polysomnography (PSG) data remain strictly blinded to the allocation sequence. To maintain this blinding, an independent, unblinded study coordinator is designated to handle the sequence assignment envelopes and remotely configure the backend audio tracks. This coordinator has no role in participant testing, clinical assessment, or subsequent data analysis.
Participants in this sequence receive the Sham condition (Standard Music) on Laboratory Night 1 (Study Day 2). On Laboratory Night 2 (Study Day 3), they cross over to receive the Experimental condition (AI-driven Neuromodulation Music). Following laboratory discharge, they continue using the AI-driven Neuromodulation Music during the 14-day naturalistic home extension phase (Days 4-14).
Participants in this sequence receive the Experimental condition (AI-driven Neuromodulation Music) on Laboratory Night 1 (Study Day 2). On Laboratory Night 2 (Study Day 3), they cross over to receive the Sham condition (Standard Music). Following laboratory discharge, they continue using the Standard Music during the 14-day naturalistic home extension phase (Days 4-14).
Shenzhen, Guangdong 518100, China
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