Efficacy and Accuracy of an AI-Driven Sleep Earbud for Chronic Insomnia
NCT: NCT07744581 · ACTIVE_NOT_RECRUITING
Brief 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.
Frequently Asked Questions
What is Efficacy and Accuracy of an AI-Driven Sleep Earbud for Chronic Insomnia?
Efficacy and Accuracy of an AI-Driven Sleep Earbud for Chronic Insomnia is a clinical trial registered under NCT07744581. Current status: ACTIVE_NOT_RECRUITING.
What is the status of NCT07744581?
The current status of NCT07744581 (Efficacy and Accuracy of an AI-Driven Sleep Earbud for Chronic Insomnia) is: ACTIVE_NOT_RECRUITING.
When did Efficacy and Accuracy of an AI-Driven Sleep Earbud for Chronic Insomnia start?
Efficacy and Accuracy of an AI-Driven Sleep Earbud for Chronic Insomnia started on 2026-07-01.
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Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.