insomnia
Conditions
Interventions
Acupuncture group:acupuncture treatment
health control group:none
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) The diagnostic criteria for Western medicine refer to the 2014 International Classification of Sleep Disorders (ICSD-3) and 2017 Chinese Adult Insomnia Diagnosis and Treatment Guidelines released by the American Sleep Medicine Association. The diagnostic criteria for CI must meet the following A-F criteria: A. The patient complained, or was discovered by the patient's parents or caregivers, of one or more of the following symptoms: 1) Difficulty falling asleep. 2) Difficulty in maintaining sleep. 3) Wake up earlier than expected. 4) Refuse to go to bed at the appropriate time. 5) Difficulty falling asleep without parental or caregiver intervention. B. The patient's chief complaint, or the discovery of one or more of the following symptoms related to nighttime sleep difficulties by parents or caregivers: 1) Fatigue/discomfort. 2) Impaired attention, concentration, or memory. 3) Impaired social, family, and occupational functions, or decreased academic performance. 4) Emotional instability/irritability. 5) Sleepy during the day. 6) Behavioral issues (such as hyperactivity, impulsivity, aggressive behavior). 7) Lack of enthusiasm, energy, or motivation. 8) Increase the likelihood of errors/accidents occurring. 9) Concerned or dissatisfied with sleep. C. The main complaint of sleep/wakefulness difficulties cannot be simply explained by insufficient sleep opportunities (such as allocating sufficient sleep time) or poor sleep environment (such as safe, dark, quiet, comfortable environment). D. Sleep disorders and related daytime symptoms occur at least three times a week. E. Sleep disorders and related daytime symptoms persist for at least 3 months. F. Sleep/wakefulness difficulties cannot be better explained by another sleep disorder. (2) Diagnostic criteria for traditional Chinese medicine: Referring to the content on insomnia in the 2022 edition of the "Diagnosis and Therapeutic Efficacy Criteria for Traditional Chinese Medicine Diseases" issued by the State Administration of Traditional Chinese Medicine, the syndrome type adopts the deficiency of both heart and spleen: 1. Mild cases may have difficulty falling asleep or may wake up easily, but may not sleep after waking up. Severe cases may have difficulty sleeping all night; 2. Often accompanied by symptoms such as headache, dizziness, palpitations, forgetfulness, and excessive dreaming. Heart and spleen deficiency type: easy to wake up from multiple dreams, or hazy and unreal, palpitations, forgetfulness, dizziness and dizziness, mental fatigue and fatigue, and dull complexion. The tongue is pale, the coating is thin, and the veins are thin and weak. Chronic Insomnia 1. Meet the diagnostic criteria of Western medicine, traditional Chinese medicine, and syndrome classification for the aforementioned CI; 2. 18 years old = Age = 70 years old, regardless of gender; 3. ISI = 8 points; 4. HAMD-17 = 7 points; 5. No mental or intellectual abnormalities, able to understand the provisions of various scales and complete evaluations; 6. Agree to participate in this study and sign a written informed consent form. Healthy population 1. 18 years old = Age = 70 years old, regardless of gender; 2. ISI<8 points; 3. HAMD-17 = 7 points; 4. After comprehensive evaluation of enrollment, there are no insomnia related symptoms; 5. No mental or intellectual abnormalities, able to understand the provisions of various scales and complete evaluations; 6. No significant gastrointestinal symptoms (such as abdo
Exclusion criteria
Exclusion criteria: Chronic Insomnia 1. Long term night work or irregular sleep patterns; 2. Have a history of drug abuse or addiction; 3. Insomnia caused by tumors, inflammatory reactions, endocrine and metabolic diseases, medication, pain, etc; 4. Have taken sedative hypnotic drugs or antipsychotic drugs (excluding emergency medication) within 4 weeks prior to the baseline visit, or have received other treatments related to insomnia (such as cognitive-behavioral therapy) within 3 months prior to the baseline visit; 5. Concomitant serious primary diseases such as heart, lung, kidney, or hematopoietic system; 6. Pregnant or lactating patients; 7. Those who have used antibiotics or other drugs that may affect gut microbiota and inflammatory cytokines within the first 4 weeks of enrollment, or have received fecal transplantation that affects the therapeutic effect; 8. Have a history of gastrointestinal surgery, inflammatory bowel disease, intestinal stress syndrome, liver disease, or autoimmune diseases; 9. The acupuncture site may have ulcers, abscesses, skin infections, etc; 10. Participate in other clinical medical trials within the past two months. Healthy population 1. Long term night work or irregular sleep patterns; 2. Have a history of drug abuse or addiction; 3. Patients with severe primary diseases, infectious diseases, tumors, and psychiatric disorders such as heart, brain, kidney, and hematopoietic system; 4. Pregnant or lactating patients; 5. Those who have used antibiotics or other drugs that may affect gut microbiota and inflammatory cytokines within the first 4 weeks of enrollment, or have received fecal transplantation, which affects the efficacy and judgment; 6. History of gastrointestinal surgery, inflammatory bowel disease, intestinal stress syndrome, liver disease, autoimmune or endocrine metabolic diseases; 7. Participate in other clinical medical trials within the past two months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment response rate of Insomnia Severity Index(ISI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of Insomnia Severity Index(ISI);Treatment response rate of Insomnia Severity Index(ISI);Treatment remission rate of Insomnia Severity Index;Actigraph sleep assessment;Generalized Anxiety Disorder Scale(GAD-7);Patient Health Questionnaire-9(PHQ-9);SF-12 scale;Gastrointestinal Symptom Rating Scale;Usage of remedial drugs; | — |
Countries
China
Contacts
Public ContactYue Lai Chen
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed