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

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.

Conditions

• Insomnia
• Insomnia Chronic
• Insomnia Disorders
• Sleep Wake Disorders

Interventions

DEVICE

AI-driven Neuromodulation Music (NeuroRhythm)

Acoustic stimulation delivered via the ANKER soundcore Sleep A40 Pro earbuds. This experimental condition utilizes the proprietary NeuroRhythm closed-loop algorithm to dynamically adjust music parameters (including timbre, tempo, white noise, and binaural beats) in real time. The acoustic adjustments are driven by the participant's live biological feedback (heart rate variability and motion data) captured by the earbud's embedded in-ear photoplethysmography (PPG) sensor.

DEVICE

Standard Music (Sham Control)

Acoustic stimulation delivered via the identical ANKER soundcore Sleep A40 Pro earbuds. This control condition plays standard, non-adaptive relaxation music pre-selected to match the participant's baseline audio preferences. The acoustic properties remain completely static throughout the night and do not adjust or respond to any real-time biometric or physiological feedback from the user.

Sponsors & Collaborators

• Chinese University of Hong Kong

  collaborator OTHER

• The Chinese University of Hong Kong, Shenzhen

  lead OTHER

Principal Investigators

• Alice KY Siu, MMed, FRCSEd(ORL) · The Chinese University of Hong Kong, Shenzhen

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2026-10-30

Completion

2027-06-30

Countries

• China

Study Locations