Chronic insomnia
Conditions
Interventions
Observation group:None
Sponsors
Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. It meets the diagnostic criteria for insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition(DSM-5); 2. Aged 18 to 75, right-handed; 3. Insomnia symptoms persist for more than 3 months and occur at least 3 times a week; 4. The baseline total score of the Pittsburgh Sleep Quality Index was >=8 points, the 17-item Hamilton Depression Scale was <20 points, and the 14-item Hamilton Anxiety Scale was <21points; 5. No drugs or substances acting on the nervous system have been taken in the past month, and no other neuroregulatory treatments such as transcranial electrical stimulation or transcranial magnetic stimulation have been received; 6. Be capable of receiving low-intensity transcranial ultrasound stimulation treatment and be able to cooperate to complete the collection of nuclear magnetic resonance data; 7. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those with severe physical diseases, such as coronary heart disease, malignant tumors, renal failure, etc; 2. Those with concurrent organic brain diseases; 3. Those with any other mental disorders, personality disorders, or abuse or dependence on psychoactive substances; 4. Those who cannot be eluted by drug treatment; 5. Currently using drugs known to cause insomnia, such as steroids, etc; 6. Coexisting other sleep disorders, such as sleep apnea-hypopnea syndrome, rapid eye movement sleep behavior disorder, narcolepsy and restless legs syndrome, etc; 7. Those with implanted devices such as cochlear implants, pacemakers, and deep brain stimulation devices in their bodies; 8. Typical contraindications for magnetic resonance imaging (MRI) scans, such as claustrophobia; 9. Pregnant and lactating women; 10. Participate in other ongoing clinical trials at the same time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart rate (HR), heart rate variability (HRV), respiration, sleep apnea and body movement during sleep;Sleep onset latency (SOL), total sleep time (TST), and sleep efficiency (SE);The changes of electroencephalogram data before and after ultrasound stimulation;Sleep time, wake-up time, sleep time, wake-up time;Ford Stress Insomnia Response Test (FIRST) Scale, HAMA Anxiety Scale, HAMD Depression Scale, Flinders Fatigue Scale, Epworth Sleepiness Scale(ESS), Symptom Checklist 90 (SCL-90) score;Insomnia Severity Index,ISI;Functional magnetic resonance imaging(fMRI);Peripheral blood hematology, serum biochemical indicators, and single-cell transcriptomics of immune cells; | — |
Countries
China
Contacts
Public ContactTao Tao
Zhujiang Hospital of Southern Medical University
Outcome results
None listed