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Study on the modulation mechanism of "heart-brain spatiotemporal synchronization" in patients with insomnia and anxiety regulated by Tiaoshen acupuncture therapy based on HEP-HRV and fMRI

Study on the modulation mechanism of "heart-brain spatiotemporal synchronization" in patients with insomnia and anxiety regulated by Tiaoshen acupuncture therapy based on HEP-HRV and fMRI

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088700
Enrollment
Unknown
Registered
2024-08-26
Start date
2024-08-31
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

insomnia with anxiety

Interventions

acupuncture group :Tiaoshen acupuncture to obtain qi and select acupoints such as Baihui, Sishencong, and Shenmen,leaving the needle for 30 minutes. If insomnia worsens, oral administration of Zopicl
sham acupuncture group:Using Park comfort devices and needles, the needle tip does not penetrate the epidermis to avoid needle effects, leaving the needle for 30 minutes. Acupuncture acupoint selectio
healthy subjects group:After recruitment, healthy subjects will undergo a clinical neurobehavioral scale assessment, synchronous collection of electrocardiogram and electroencephalogram signals, HRV d

Sponsors

Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for patients with insomnia and anxiety 1. Meets diagnostic criteria for ID and GAD in DSM-5 2.Age range from 18 to 60 years old 3. Pittsburgh Sleep Quality Index (PSQI) score>8 points 4. 14 = Hamilton Anxiety Scale (HAMA) (14 items) score32 points 7. Junior high school or above education level 8. Having sufficient comprehension skills to complete the necessary checks and tests for research; 9. Subject signs informed consent form 10. Not taking any anti anxiety, depression, or sleep medication in the past month 11. No acupuncture treatment for insomnia 12. Right handedness Inclusion criteria for healthy subjects 1. Age range: 18-60 years old 2. No complaints of dissatisfaction with the quantity or quality of sleep 3. Pittsburgh Sleep Quality Index (PSQI) score<8 points 4. Hamilton Anxiety Scale (HAMA) (14 items) score<7 points 5. Hamilton Depression Rating Scale (HAMD) (17 items) score<7 points 6. Excessive Awakening Scale (HAS) score<32 points 7. No history of significant organic or mental disorders 8. No contraindications for MRI examination 9. I have signed the informed consent form 10. Junior high school education or above; 11. Having sufficient comprehension ability to complete the necessary checks and experiments for research; 12. No family history of mental disorders. 13. Individuals without serious physical illnesses, abusers of psychoactive substances, pregnant or lactating women. 14. Right-handed hand Note: To be included in this study, insomnia patients must meet the above criteria and match their age, gender, and years of education.

Exclusion criteria

Exclusion criteria: Exclusion criteria for insomnia with anxiety patients 1. Patients with severe anxiety, depression, bipolar disorder, schizophrenia, Alzheimer's disease, and vascular dementia 2. Patients with severe heart, brain, kidney, liver and other diseases 3. Alcohol or drug dependent individuals 4. Individuals who cannot cooperate with neurobehavioral evaluation, electrocardiogram monitoring, imaging examination, and acupuncture treatment 5. Patients with apnea syndrome and restless leg syndrome 6. Pregnant and lactating women 7. Claustrophobia or other contraindications for magnetic resonance imaging examination 8. Patients with abnormal brain structure or severe asymmetry of head anatomical structure Those who meet one of the above criteria will be excluded

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality index,;

Secondary

MeasureTime frame
Hamilton anxiety scale, HAMA ;Insomnia Severity Index, ISI;Hyperarousal scale,HAS ;Hamilton depression scale, HAMD ;Fatigue Scale-14,FS-14;sleep diary;heartbeat evoked potentials (HEPs) ;brain functional magnetic resonance imaging; heart rate variability (HRV);

Countries

China

Contacts

Public ContactGuo Jing

Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University

guojing_2002@163.com+86 136 5111 9255

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026