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

Phase 1

Recruiting

• Conditions: insomnia with anxiety

• Registration Number: ChiCTR2400088700
• Lead Sponsor: Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria for patients with insomnia and anxiety<br>1. Meets diagnostic criteria for ID and GAD in DSM-5<br>2.Age range from 18 to 60 years old<br>3. Pittsburgh Sleep Quality Index (PSQI) score>8 points<br>4. 14 = Hamilton Anxiety Scale (HAMA) (14 items) score<29 points, mild to moderate anxiety<br>5. Hamilton Depression Rating Scale (HAMD) (17 items) score<7 points<br>6. Excessive Awakening Scale (HAS) score>32 points<br>7. Junior high school or above education level<br>8. Having sufficient comprehension skills to complete the necessary checks and tests for research;<br>9. Subject signs informed consent form<br>10. Not taking any anti anxiety, depression, or sleep medication in the past month<br>11. No acupuncture treatment for insomnia<br>12. Right handedness<br><br>Inclusion criteria for healthy subjects<br>1. Age range: 18-60 years old<br>2. No complaints of dissatisfaction with the quantity or quality of sleep<br>3. Pittsburgh Sleep Quality Index (PSQI) score<8 points<br>4. Hamilton Anxiety Scale (HAMA) (14 items) score<7 points<br>5. Hamilton Depression Rating Scale (HAMD) (17 items) score<7 points<br>6. Excessive Awakening Scale (HAS) score<32 points<br>7. No history of significant organic or mental disorders<br>8. No contraindications for MRI examination<br>9. I have signed the informed consent form<br>10. Junior high school education or above;<br>11. Having sufficient comprehension ability to complete the necessary checks and experiments for research;<br>12. No family history of mental disorders.<br>13. Individuals without serious physical illnesses, abusers of psychoactive substances, pregnant or lactating women.<br>14. Right-handed hand<br>Note: To be included in this study, insomnia patients must meet the above criteria and match their age, gender, and years of education.<br><br> <br>

Exclusion Criteria

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

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality index,;

Secondary Outcome Measures

Name	Time	Method
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);