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

NCT07744581 | Active Not Recruiting

• 1 other identifier: CUHKSZ-D-20260061
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Insomnia; Insomnia Chronic; Insomnia Disorders; Sleep Wake Disorders

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in Polysomnography (PSG)-Measured Sleep Onset Latency (SOL)

  The objective time, in minutes, from turning the lights off to the appearance of the first continuous epoch of sleep, as recorded by the mobile PSG system.

  Measured on Laboratory Night 1 (Day 2 morning) and Laboratory Night 2 (Day 3 morning).

• Change from Baseline in Percentage of Slow Wave Sleep (N3 Stage)

  The percentage of total sleep time spent in the N3 deep sleep stage (slow-wave sleep), derived from the objective PSG recordings scored according to AASM standards.

  Measured on Laboratory Night 1 (Day 2 morning) and Laboratory Night 2 (Day 3 morning).

• Change from Baseline in Insomnia Severity Index (ISI) Score

  The ISI is a 7-item self-report instrument assessing the nature, severity, and impact of insomnia. The total score ranges from 0 to 28, where 0-7 indicates no clinically significant insomnia and 22-28 indicates severe clinical insomnia. A reduction in score represents an improvement in insomnia severity.

  Baseline (Day 1), Post-Laboratory (Day 3), and Endpoint (Day 14).

Secondary Outcomes (5)

• Sleep Stage Classification Agreement (Cohen's Kappa)

  Evaluated continuously across Laboratory Nights 1 and 2 (Days 2 and 3)

• Sensor Signal Accuracy for Heart Rate Variability (HRV) - RMSSD Metric

  Evaluated continuously across Laboratory Nights 1 and 2 (Days 2 and 3).

• Change from Baseline in Psychomotor Vigilance Task (PVT) Reaction Time

  Baseline (Day 1), Day 2 morning, Day 3 morning, and Follow-up Endpoint (Day 14).

• Change from Baseline in Mood Symptoms (PHQ-9)

  Baseline (Day 1) and Follow-up Endpoint (Day 14).

• Change from Baseline in Anxiety Symptoms (GAD-7)

  Baseline (Day 1) and Follow-up Endpoint (Day 14).

Study Arms (2)

Sequence 1 (A-B)

EXPERIMENTAL

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).

Device: AI-driven Neuromodulation Music (NeuroRhythm); Device: Standard Music (Sham Control)

Sequence 2 (B-A)

EXPERIMENTAL

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).

Device: AI-driven Neuromodulation Music (NeuroRhythm); Device: Standard Music (Sham Control)

Interventions

AI-driven Neuromodulation Music (NeuroRhythm) DEVICE

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.

Sequence 1 (A-B); Sequence 2 (B-A)

Standard Music (Sham Control) DEVICE

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.

Sequence 1 (A-B); Sequence 2 (B-A)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18 to 55 years (inclusive).
• Able to understand the study protocol and voluntarily sign the informed consent form.
• Meets the diagnostic criteria for chronic insomnia disorder according to the International Classification of Sleep Disorders, Third Edition (ICSD-3) or DSM-5.
• Duration of insomnia symptoms is greater than 3 months but less than 2 years.
• Insomnia Severity Index (ISI) total score \> 8 (indicating mild or greater clinical insomnia).
• Currently drug-free status: No use of any prescription or over-the-counter medications that affect sleep (including sedatives, hypnotics, antidepressants, antihistamines, or traditional Chinese medicine sleep aids) for at least 2 weeks (or more than 5 drug half-lives) prior to enrollment.
• Owns a smartphone and is capable of operating mobile applications to complete electronic questionnaires.
• Willing and able to tolerate wearing earplugs or earbuds during sleep.

You may not qualify if:

• Comorbid primary sleep disorders: Diagnosed via screening (STOP-Bang questionnaire) or polysomnography (PSG) with moderate-to-severe obstructive sleep apnea (OSA, defined as Apnea-Hypopnea Index $\\ge$ 15), narcolepsy, periodic limb movement disorder (PLMD), or other sleep disorders that could interfere with sleep quality assessments.
• Severe psychiatric or psychological conditions: A Patient Health Questionnaire (PHQ-9) score \> 10 or a Generalized Anxiety Disorder scale (GAD-7) score \> 10.
• History of schizophrenia, bipolar disorder, major depressive disorder, or active suicidal ideation.
• Active substance abuse or dependence: History of alcohol abuse (exceeding 14 standard drinks per week) or illicit drug use within the past 3 months.
• Comorbid somatic medical conditions: Severe or unstable physical illnesses (e.g., severe heart failure, malignant tumors, chronic pain) or neurological disorders known to impair sleep monitoring accuracy.
• Active ear diseases, ear canal discharge, structural abnormalities, or a history of related otologic surgeries that prevent or restrict earbud placement.
• Known history of hypersensitivity or allergic reactions to silicone or plastic materials.
• Disruptive lifestyle factors: Current engagement in shift work schedules or travel across more than 3 time zones within 2 weeks prior to study entry.
• Inability to provide independent informed consent or successfully complete cognitive testing due to profound language or cognitive barriers.

Sponsors & Collaborators

• The Chinese University of Hong Kong, Shenzhen: lead
• Chinese University of Hong Kong: collaborator

Study Sites (2)

Longgang Ear, Nose and Throat Hospital

Shenzhen, Guangdong, 518100, China

Location

The Chinese University of Hong Kong Shenzhen

Shenzhen, Guangdong, 518172, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alice KY Siu, MMed, FRCSEd(ORL)

  The Chinese University of Hong Kong, Shenzhen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: This study utilizes a randomized, 1:1 allocated, 2-sequence, 2-period crossover design for the acute laboratory phase (Nights 2 and 3), which immediately transitions into a 14-day naturalistic home-use extension phase (Days 4-14). In Period 1 (Laboratory Night 1 / Study Day 2), participants assigned to Sequence 1 receive Intervention A (Sham/Standard Music), while those in Sequence 2 receive Intervention B (AI-driven Neuromodulation Music). In Period 2 (Laboratory Night 2 / Study Day 3), participants cross over to the alternate condition, where Sequence 1 receives Intervention B and Sequence 2 receives Intervention A. No washout period is instituted between the two laboratory nights due to the acute, non-residual nature of acoustic stimulation and to optimize protocol compliance. Following laboratory discharge on Day 3, participants transition to the home extension phase, where they continue using the specific intervention assigned during their final laboratory night (Sequence 1 contin

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: August 4, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)