Sleep Initiation and Maintenance Disorders Clinical Trial
Official title:
Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial
This trial intends to observe the clinical efficacy and safety of grain moxibustion at Baihui(GV20), Xinshu(BL15) and Pishu(BL20) in the treatment of insomnia.
Status | Not yet recruiting |
Enrollment | 102 |
Est. completion date | July 31, 2025 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Meet the diagnostic criteria of insomnia; 2. TCM syndrome differentiation belongs to deficiency of both heart and spleen; 3. Male or female participants aged 18-75; 4. Participants whose PSQI score is 5-15; 5. The course of disease is more than 3 months; 6. Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial. Exclusion Criteria: 1. Participants with mental retardation; 2. Participants with serious cardiovascular diseases, liver, kidney and hematopoietic system diseases; 3. Insomnia is caused by nervous system diseases (such as stroke, Parkinson's disease) or mental disorders (including depression or anxiety); 4. Female participants who is pregnant or lactating; 5. Participants with diabetes and sensory dysfunction. 6. Participants with skin diseases of acupoints; 7. Taking sedative hypnotics (including barbiturates, benzodiazepines, tranquilizers, diphenylmethane, etc) and other insomnia related drugs within 2 weeks before the trial; 8. Participants with dependence on sleeping drugs; 9. Participants suffering from malignant tumor, sequelae of severe cerebral apoplexy, organ failure and other major diseases that affect insomnia and therapeutic effect. |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Institute of Acupuncture, Moxibustion and Meridian | Shanghai | Shanghai |
China | Shanghai Institute of Acupuncture, Moxibustion and Meridian | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai Institute of Acupuncture, Moxibustion and Meridian | Shanghai University of Traditional Chinese Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Blind evaluation | The participants will be asked to predict whether they were treated by grain moxibustion or sham grain moxibustion according to their self feelings. | Week 4 | |
Other | Abnormalities after the moxibustion | Abnormalities after the moxibustion are skin scald, blistering or other discomfort caused by the moxibustion. Doctors will always have a burn ointment to prevent burns. If the patient gets a blister, the doctor will deal with it in time and inform the patient of the follow-up protective measures. | Week 4 | |
Primary | Changes of Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) is a widely-used questionnaire to assess one's sleep disorders over one month. It is comprised of 19 self-rated items and 5 other-rated items. The scores include the following indicators: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of medication, and daytime dysfunction. Each indicator is rated from 0 to 3. The accumulated scores of the seven indicators constitute the total score of PSQI (0-21). The higher score indicates the worse sleep quality and severer sleep disorders. The investigators set the changes of PSQI scores between baseline to week 4 as the primary outcome, to evaluate the effectiveness of acupuncture for depression related insomnia. | Baseline and week 4 | |
Secondary | Changes of PSQI scores | As is mentioned above, PSQI is a widely-used questionnaire to assess one's sleep disorders over one month. In order to assess the effects of acupuncture on patients' sleep quality during the intervention period, and to assess the durative effects of acupuncture after the intervention ends, the investigators set the changes of PSQI scores between baseline to week 8 and week 12 as the secondary outcome. | Baseline and week 12 | |
Secondary | Sleep monitoring of bracelet | Xiaomi Bracelet 3(XMSH05HM)will be worn on the wrist of the participants, recording the sleep time at night, deep sleep time, light sleep time, awake time, time to fall asleep last night and time to wake up this morning. | Week 12 | |
Secondary | Changes of Athens Insomnia Scale(AIS) | Using the Athens Insomnia Scale to test the subjective sleep quality of patients. It is comprised of 8 items. The range were from 0-3. Total score < 4 means sleep well; total score =4-6 means suspicious of insomnia; total score > 6 means insomnia. The changes of AIS scores between baseline to week 4, week 8 and week 12 are the secondary outcome. | Baseline and week 12 | |
Secondary | Changes of Generalized Anxiety Disorder Scale-7(GAD-7) | Changes in anxiety will be measured using the Generalized Anxiety Disorder Scale (GAD-7), which contains 7 items with total scores ranging from 0 to 21. Scores of 5, 10, and 15 are cut-offs for mild, moderate, and severe anxiety, respectively. An add-on item assessing the patient's global impression of symptom-related impairment helps researchers understand the extent to which anxiety interferes in daily life. The GAD-7 has factorial validity for the diagnosis of general anxiety disorder and is sensitive to change. The changes of GAD-7 scores between baseline to week 4, week 8 and week 12 are the secondary outcome. | Baseline and week 12 | |
Secondary | Changes of Patient Health Questionnaire-9 (PHQ-9) | Changes in depressive symptoms will be measured using the 9-item Patient Health Questionnaire-9 (PHQ-9) to assess depressive symptoms. With total scores ranging from 0 to 27, scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression, respectively. The PHQ-9 has factorial validity for the diagnosis of major depressive disorder. The changes of PHQ-9 scores between baseline to week 4, week 8 and week 12 are the secondary outcome. | Baseline and week 12 | |
Secondary | Recurrence observation during the follow-up period | In case of relapse (PSQI score increase rate > 50% or need to adjust drugs to control the disease) or serious adverse reactions during the follow-up period, the time from the beginning to the end of treatment , the specific medication plan and the state of illness during the follow-up period will be recorded. The recurrence rate and average recurrence time during the follow-up period will be calculated according to the number of recurrence within week 4 to week 12 follow-up in each group. | Week 12 | |
Secondary | Dose dairy | Compare the use rate and dosage of estazolam during treatment and follow-up. | 12 weeks |
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