Efficacy and Accuracy of an AI-driven Neuromodulation Ear-worn Device for Chronic Insomnia: A Randomized Controlled Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change from Baseline in Polysomnography (PSG)-Measured Sleep Onset Latency (SOL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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 >
- •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.
结局指标
主要结局
Change from Baseline in Polysomnography (PSG)-Measured Sleep Onset Latency (SOL)
时间窗: Measured on Laboratory Night 1 (Day 2 morning) and Laboratory Night 2 (Day 3 morning).
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.
Change from Baseline in Percentage of Slow Wave Sleep (N3 Stage)
时间窗: Measured on Laboratory Night 1 (Day 2 morning) and Laboratory Night 2 (Day 3 morning).
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.
Change from Baseline in Insomnia Severity Index (ISI) Score
时间窗: Baseline (Day 1), Post-Laboratory (Day 3), and Endpoint (Day 14).
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.
次要结局
- 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).)
研究者
Alice Kwai-Yee Siu
Clinical Associate Professor
The Chinese University of Hong Kong, Shenzhen