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Smart earbuds that listen to your heart could lull you to sleep

NCT ID NCT07744581

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This trial tests a pair of smart earbuds that use artificial intelligence to adjust soothing music in real time based on your heart rate and movement, aiming to help people with chronic insomnia fall asleep faster and sleep deeper. Adults with chronic insomnia will spend three nights in a sleep lab, trying both the AI-adaptive music and standard non-adaptive music, while researchers compare the earbuds' built-in sensors against clinical sleep monitoring equipment. After the lab phase, participants use the earbuds at home for two weeks. The goal is to see if personalized sound therapy can ease insomnia and if a consumer earbud can track sleep as accurately as a hospital system.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AI-driven neuromodulation music delivered via smart earbuds (NeuroRhythm)
What this could lead to
If effective, this could offer a drug-free, personalized way to treat chronic insomnia and validate consumer earbuds as accurate sleep trackers.
What could go wrong
This is a small early-stage trial (25 people) and results may not apply to everyone. The device's accuracy and effectiveness compared to standard music are still unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Longgang Ear, Nose and Throat Hospital

    Shenzhen, Guangdong, 518100, China

  • The Chinese University of Hong Kong Shenzhen

    Shenzhen, Guangdong, 518172, China

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