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

Insomnia, Insomnia Chronic, Insomnia Disorders, Sleep Wake Disorders

Randomized Clinical Trial, Acoustic Neuromodulation, Closed-Loop Stimulation, Sound Therapy, Music Therapy, Wearable Electronic Devices, Artificial Intelligence, Polysomnography, Photoplethysmography, Heart Rate Variability, Neurocognitive Test (CANTAB), Actigraphy

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.

This randomized, double-blind, two-sequence crossover clinical trial is designed to evaluate both the therapeutic efficacy of a closed-loop acoustic neuromodulation ear-worn device and the measurement accuracy of its embedded sensors against gold-standard laboratory diagnostics. The study architecture is executed across two distinct phases: a controlled laboratory phase followed by a naturalistic home-use extension. Phase 1: Controlled Laboratory Assessment and Screening (Days 1-3) Participants undergo consecutive three-night stays within a regulated hospital sleep medicine center. Night 1 (Baseline and Diagnostic Screening): Participants are instrumented with a mobile polysomnography (PSG) system (SOMNOscreen™ plus) to capture baseline architecture across standard electrophysiological channels (EEG, EOG, EMG, ECG). This night serves to objectively screen for and exclude individuals presenting with hidden primary sleep disorders, specifically moderate-to-severe obstructive sleep apnea characterized by an Apnea-Hypopnea Index (AHI). No audio intervention is delivered. Nights 2 and 3 (Randomized Crossover Window): Eligible participants who pass the diagnostic screen are randomized via sequential opaque envelopes into one of two intervention sequences (A-B or B-A). Allocation concealment is maintained by an independent unblinded study coordinator who programs the mobile application remotely, leaving the participant and data analyst blind to the track delivery. On one night, participants receive the experimental condition (AI-driven neuromodulation utilizing the NeuroRhythm algorithm to dynamically alter acoustic masking parameters based on real-time biometric feedback). On the alternate night, participants receive the sham condition (standard, non-adaptive acoustic music). Continuous PSG tracking runs concurrently both nights to allow epoch-by-epoch matrix synchronization between the earbud's internal sensor metrics and clinical hardware. Neurocognitive and Subjective Profiling On the mornings following Nights 1, 2, and 3, participants undergo standardized tracking procedures. Automated neurocognitive performance is mapped using the Cambridge Neuropsychological Test Automated Battery (CANTAB) touchscreen system to evaluate transient shifts in sustained attention, psychomotor alertness, and working memory efficiency linked to sleep structural changes. Subjective sleep depth, freshness, and hardware comfort metrics are gathered via morning clinical diaries. Phase 2: Naturalistic Home Extension and Endpoint (Days 4-14) Upon discharge from the sleep laboratory on Day 3, participants transition into a 14-day home-use window to assess the cumulative real-world utility of the intervention. Participants utilize the wearable earbud during sleep in their home environments according to their final laboratory sequence protocol assignment. Compliance, device tolerability, and subjective rest patterns are tracked daily via electronic logs. On Day 14, participants return for a final clinical endpoint visit to complete comprehensive psychometric re-evaluations, repeat the full-length neurocognitive battery (CANTAB), turn in all hardware, and execute the data collection confirmation logs.

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