Efficacy and Accuracy of an AI-Driven Sleep Earbud for Chronic Insomnia (NCT07744581) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Efficacy and Accuracy of an AI-Driven Sleep Earbud for Chronic Insomnia
China25 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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 schizophreni…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing an AI-driven sleep earbud — can you help me understand how wearing a device in my ear all night might work for chronic insomnia compared to treatments I might already be doing, like CBT-I or sleep medications?
2The trial is measuring how long it takes me to fall asleep and how much deep sleep I get using a full overnight sleep study called polysomnography — do I need to be comfortable with that level of monitoring, and what does that process actually involve?
3Since this trial is listed as 'active, not recruiting,' does that mean there's no way to join it, and if so, are there similar device-based or non-drug insomnia studies you'd recommend I look into instead?
4This study is in a phase labeled 'NA,' which often applies to device or behavioral trials — what does that mean for how much we already know about whether this earbud is safe and effective for someone with my specific sleep history?
5Given that the trial uses the Insomnia Severity Index as one of its main measures, is my current insomnia severity level the kind that would typically be studied in a trial like this, or would a more established treatment be a better starting point for me right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Polysomnography (PSG)-Measured Sleep Onset Latency (SOL)
Timeframe: Measured on Laboratory Night 1 (Day 2 morning) and Laboratory Night 2 (Day 3 morning).
2
Change from Baseline in Percentage of Slow Wave Sleep (N3 Stage)
Timeframe: Measured on Laboratory Night 1 (Day 2 morning) and Laboratory Night 2 (Day 3 morning).
3
Change from Baseline in Insomnia Severity Index (ISI) Score