InsomniaNCT07744581
Efficacy and Accuracy of an AI-Driven Sleep Earbud for Chronic Insomnia
A study testing AI-driven Neuromodulation Music (NeuroRhythm) in people with Insomnia and Insomnia Chronic, run by The Chinese University of Hong Kong, Shenzhen at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Insomnia, Insomnia Chronic, Insomnia Disorders
- What is being tested?
- AI-driven Neuromodulation Music (NeuroRhythm)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Longgang Ear, Nose and Throat Hospital
Shenzhen, Guangdong, 518100
The Chinese University of Hong Kong Shenzhen
Shenzhen, Guangdong, 518172
About this study
Official title: Efficacy and Accuracy of an AI-driven Neuromodulation Ear-worn Device for Chronic Insomnia: A Randomized Controlled Crossover Trial
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.
Read the detailed description
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.
Neurocognitive and Subjective Profiling
On the mornings following Nights 1, 2, and 3, participants undergo standardized tracking procedures. Automated neurocognitive performance is mapped using the Cambridge Neuropsychological Test Automated Battery (CANTAB) touchscreen system to evaluate transient shifts in sustained attention, psychomotor alertness, and working memory efficiency linked to sleep structural changes. Subjective sleep depth, freshness, and hardware comfort metrics are gathered via morning clinical diaries.
Phase 2: Naturalistic Home Extension and Endpoint (Days 4-14)
Upon discharge from the sleep laboratory on Day 3, participants transition into a 14-day home-use window to assess the cumulative real-world utility of the intervention. Participants utilize the wearable earbud during sleep in their home environments according to their final laboratory sequence protocol assignment. Compliance, device tolerability, and subjective rest patterns are tracked daily via electronic logs. On Day 14, participants return for a final clinical endpoint visit to complete comprehensive psychometric re-evaluations, repeat the full-length neurocognitive battery (CANTAB), turn in all hardware, and execute the data collection confirmation logs.
- Conditions
- Insomnia, Insomnia Chronic, Insomnia Disorders, Sleep Wake Disorders
- Being tested
- AI-driven Neuromodulation Music (NeuroRhythm), Standard Music (Sham Control)
- 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
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: AI-driven Neuromodulation Music (NeuroRhythm); Device: Standard Music (Sham Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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.
Measured: Baseline (Day 1), Post-Laboratory (Day 3), and Endpoint (Day 14).
Secondary outcomes (5)
Sleep Stage Classification Agreement (Cohen's Kappa)
The epoch-by-epoch classification agreement between the earbud's automated AI sleep staging algorithm and the manually scored gold-standard PSG across a 4-stage sleep model (Wake, Light, Deep, REM). Agreement is quantified using the Cohen's Kappa coefficient.
Measured: Evaluated continuously across Laboratory Nights 1 and 2 (Days 2 and 3)
Sensor Signal Accuracy for Heart Rate Variability (HRV) - RMSSD Metric
The measurement accuracy of the earbud's photoplethysmography (PPG) sensor against the reference PSG electrocardiogram (ECG) channel. Accuracy is calculated using the intra-class correlation coefficient (ICC) of the Root Mean Square of Successive Differences (RMSSD) in milliseconds.
Measured: Evaluated continuously across Laboratory Nights 1 and 2 (Days 2 and 3).
Change from Baseline in Psychomotor Vigilance Task (PVT) Reaction Time
Measured using the automated Cambridge Neuropsychological Test Automated Battery (CANTAB) on a touchscreen tablet. This metric captures the participant's median reaction time and lapses in milliseconds to evaluate sustained visual attention.
Measured: Baseline (Day 1), Day 2 morning, Day 3 morning, and Follow-up Endpoint (Day 14).
Change from Baseline in Mood Symptoms (PHQ-9)
Evaluation of secondary emotional distress changes via the Patient Health Questionnaire (PHQ-9) for depression symptoms (score range 0 to 27). Higher scores indicate worse symptom severity.
Measured: Baseline (Day 1) and Follow-up Endpoint (Day 14).
Change from Baseline in Anxiety Symptoms (GAD-7)
Evaluation of secondary emotional distress changes via Generalized Anxiety Disorder scale (GAD-7) for anxiety symptoms (score range 0 to 21). Higher scores indicate worse symptom severity.
Measured: Baseline (Day 1) and Follow-up Endpoint (Day 14).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Jul 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Chinese University of Hong Kong, Shenzhen
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Alice Kwai-Yee Siu, The Chinese University of Hong Kong, Shenzhen
- Investigators
- Alice KY Siu, MMed, FRCSEd(ORL), Principal investigator, The Chinese University of Hong Kong, Shenzhen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744581
- Sponsor's protocol ID
- CUHKSZ-D-20260061
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Accuracy of an AI-driven Neuromodulation Ear-worn Device for Chronic Insomnia: A Randomized Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT07744581
- Acronym / sponsor ID
- CUHKSZ-D-20260061
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- The Chinese University of Hong Kong, ShenzhenUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Neurocognitive and Subjective Profiling
On the mornings following Nights 1, 2, and 3, participants undergo standardized tracking procedures. Automated neurocognitive performance is mapped using the Cambridge Neuropsychological Test Automated Battery (CANTAB) touchscreen system to evaluate transient shifts in sustained attention, psychomotor alertness, and working memory efficiency linked to sleep structural changes. Subjective sleep depth, freshness, and hardware comfort metrics are gathered via morning clinical diaries.
Phase 2: Naturalistic Home Extension and Endpoint (Days 4-14)
Upon discharge from the sleep laboratory on Day 3, participants transition into a 14-day home-use window to assess the cumulative real-world utility of the intervention. Participants utilize the wearable earbud during sleep in their home environments according to their final laboratory sequence protocol assignment. Compliance, device tolerability, and subjective rest patterns are tracked daily via electronic logs. On Day 14, participants return for a final clinical endpoint visit to complete comprehensive psychometric re-evaluations, repeat the full-length neurocognitive battery (CANTAB), turn in all hardware, and execute the data collection confirmation logs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 (A-B) | Experimental | Device: AI-driven Neuromodulation Music (NeuroRhythm), Device: Standard Music (Sham Control)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). |
| Sequence 2 (B-A) | Experimental | Device: AI-driven Neuromodulation Music (NeuroRhythm), Device: Standard Music (Sham Control)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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Sequence 1 (A-B), Sequence 2 (B-A) |
| 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. | Device | Sequence 1 (A-B), Sequence 2 (B-A) |
Primary outcome
Change from Baseline in Polysomnography (PSG)-Measured Sleep Onset Latency (SOL)
Time frame: 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)
Time frame: 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
Time frame: 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.
5 secondary outcomes
Sleep Stage Classification Agreement (Cohen's Kappa)
Time frame: Evaluated continuously across Laboratory Nights 1 and 2 (Days 2 and 3)
Sensor Signal Accuracy for Heart Rate Variability (HRV) - RMSSD Metric
Time frame: Evaluated continuously across Laboratory Nights 1 and 2 (Days 2 and 3).
Change from Baseline in Psychomotor Vigilance Task (PVT) Reaction Time
Time frame: Baseline (Day 1), Day 2 morning, Day 3 morning, and Follow-up Endpoint (Day 14).
Change from Baseline in Mood Symptoms (PHQ-9)
Time frame: Baseline (Day 1) and Follow-up Endpoint (Day 14).
Change from Baseline in Anxiety Symptoms (GAD-7)
Time frame: Baseline (Day 1) and Follow-up Endpoint (Day 14).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice KY Siu, MMed, FRCSEd(ORL) principal investigator
The Chinese University of Hong Kong, Shenzhen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-driven Neuromodulation Music (NeuroRhythm) in people with Insomnia and Insomnia Chronic, run by The Chinese University of Hong Kong, Shenzhen at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Polysomnography (PSG)-Measured Sleep Onset Latency (SOL) (time frame: Measured on Laboratory Night 1 (Day 2 morning) and Laboratory Night 2 (Day 3 morning).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.