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Exploring New Methods and Clinical Applications of Sleep Disorder Intervention by Combining Artificial Intelligence and Neuroregulation Technology

Exploring New Methods and Clinical Applications of Sleep Disorder Intervention by Combining Artificial Intelligence and Neuroregulation Technology

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125241
Enrollment
Unknown
Registered
2026-05-22
Start date
2023-02-18
Completion date
Unknown
Last updated
2026-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sleep disorder

Interventions

cTBS experimental group:continuous theta burst stimulation, cTBS
cTBS sham group:pseudo stimulation of cTBS
tACS slow-wave stimulation group:Transcranial alternating current stimulation, tACS
tACS slow-wave sham stimulation group:pseudo stimulation of tACS
tACS spindle wave stimulation group:Transcranial alternating current stimulation, tACS
tACS spindle wave sham stimulation group:pseudo stimulation of tACS
tACS alpha wave stimulation group:Transcranial alternating current stimulation, tACS
tACS alpha wave sham stimulation group:pseudo stimulation of tACS

Sponsors

Peking University Sixth Hospital (Institute of Mental Health)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Chronic Insomnia Disorder Case Group: Diagnosed outpatient/inpatient patients with ICSD-3 chronic insomnia disorder, aged 18-65, right-handed 2. Diagnosis meets the diagnostic criteria of ICSD-3 for chronic insomnia disorder 3. PSQI >= 5 points 4. No physical therapy has been applied in recent 6 months, such as MECT, rTMS, tES, acupuncture and moxibustion, etc 5. The patient has not taken any sedatives, hypnotics, antidepressants, antipsychotics, mood stabilizers, or other drugs that affect the central nervous system for at least 4 weeks prior to this episode; 6. The patient is not a shift worker; 7. Total duration of illness = 5.

Exclusion criteria

Exclusion criteria: 1. Individuals with current or past mental disorders (MINI) 2. Education years<5 years or IQ<90 points 3. Travelers who cross time zones within 3 months 4. Habitual consumption of probiotic or prebiotic products; 5. Individuals with neurological disorders, have lost consciousness due to trauma, with chronic physical illnesses or organic brain disorders, and cancer patients; 6. Individuals currently experiencing sleep disorders other than significant insomnia, such as OSA, PLMS, RLS, etc.; 7. Individuals who have consumed alcohol within 1 week prior to enrollment; 8. Individuals who consumed coffee on the afternoon before the experiment; 9. Individuals with contraindications for MRI.

Design outcomes

Primary

MeasureTime frame
Changes in cortical thickness, grey matter volume and functional networks (such as the default mode network) in functional magnetic resonance imaging;Pittsburgh Sleep Quality Index;Slow-wave oscillations, spindles and total sleep time in polysomnography;Cognitive function test scores, such as reaction times and error rates on the Attention Network Test (ANT);Changes in the resting-state beta spectrum of EEG;Insomnia Severity Index;

Countries

China

Contacts

Public ContactXueqin Wang

Peking University Sixth Hospital (Institute of Mental Health)

wangxueqin@bjmu.edu.cn+86 10 6272 3770

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026