Research for the brain regulation mechanisms of acupoint stimulation in the region of auricular vagus nerve for insomnia patients based on functional magnetic resonance imaging

Phase 1

Recruiting

• Conditions: Insomnia

• Registration Number: ITMCTR1900002284
• Lead Sponsor: Department of Radiology,The Second Clinical College of Guangzhou University of Chinese Medicine(Guangdong Provincial Hospital of Chinese Medicine)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

1. Meeting the diagnostic criteria of chronic insomnia in International Classification of Sleep Disorders (Third Edition):
(1) The patient complained that it was difficult to fall asleep or maintain sleep, wake up early, and dissatisfied with sleep quality;
(2) Patients with daytime fatigue, sleepiness, impaired attention and memory, emotional instability and prone to irritation;
(3) Patients have difficulties in falling asleep and can not be explained simply by poor sleeping environment (such as darkness, safety and comfort);
(4) The patient's sleep disorder or related daytime symptoms occured at least 3 times a week and lasted for more than 3 months;E.The cause of insomnia in patients cannot be explained by any other disea.
2. Male or female aged 18 to 70 years old;
3. The patients' symptom scores, Pittsburgh sleep score > 7 points, Insomnia severity index >14 points, 24 Hamilton depression score < 35 points (more than 20 points may have depression, greater than 35 points for severe depression), Hamilton Anxiety Scale< 29 points, Self-evaluation Anxiety Scale(SAS) standard score< 50 points , Self-rating Depression Scale (SDS) standard score< 52 points;
4. The patients agreed to participate in the clinical research and sign the informed consent. They have a certain level of education to cooperate with the the relevant insomnia/anxiety/depression score scale.

Exclusion Criteria

1. Patients with cardiovascular, digestive, liver, kidney, hematopoietic system and other serious primary diseases; patients with diseases that might be in danger through vagal nerve stimulation, such as heart failure, hyperthyroidism.
2. Patients have a history of alcoholism, drug abuse, mental illness or dementia;
3. Patients with allergy, damage or inflammation at the therapeutic site;
4. Pregnant or lactating women;
5. Patients took anticholinergics, non-steroidal anti-inflammatory drugs and hormone drugs recently. Patients are taking anti-depressants to inhibit the activity of the cerebral cortex nervous system currently;
6. There are contraindications of magnetic resonance examination such as metal implants and claustrophobia;
7. Patients participating in other clinical trials in the past six months.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Diffusion tensor imaging(DTI);Brain functional connectivity;Amplitude of low-frequency fluctuation(ALFF);Regional homogeneity(ReHo);The blood oxygen level dependent(BOLD) ;Brain arterial spin labeling(ASL);

Secondary Outcome Measures

Name	Time	Method
25-hydroxy-vitamin D;Brain-derived neurotrophic factor(BDNF);?-aminobutyric acid (GABA);