The primary purpose of this study is to discover, establish and refine the individual treatment protocol of each TCM expert for insomnia, and to explore what characteristics of the patients are considered with the corresponding treatment in clinical practices. The secondary purpose is to determine the effectiveness of TCM pattern differentiation treatment for the patients with insomnia.
Traditional Chinese medicine (TCM) has been effectively and instantly used for keeping Chinese people's health over 2000 years. Recently the TCM is becoming popular and well known home and abroad due to its effectiveness and individualized treatment. It has been known that TCM practitioners diagnosed, give the treatment and evaluated patients' health condition with symptoms and signs, what are called TCM patterns. This is why TCM practitioners always consider and emphasize the importance of TCM patterns in the TCM education and clinic practices. At the same time, TCM pattern differentiation is considered complicated and difficult to understand, due to the difference of TCM practitioners'clincal experience and knowledge. The one ,who has more experience and knowledge, treat patients more effective than the other. Unlike modernized medicine, drugs are not always recommended for the diseases, conversely, the TCM practitioners and their knowledge are always recommended. In addition, young TCM practitioners have to follow and imitate the experts who are full of knowledge, if they want to be good ones. From these views, the experience and knowledge of experts are important and crucial to the clinical outcomes, meanwhile they are hard to discover and establish. Therefore, we package the experts and their treatment as the one target to discover, establish and refine the individual treatment protocol (experience and knowledge) of each TCM expert, and to explore what characteristics of the patients are considered with the corresponding treatment in clinical practices. The prerequisite of the study is that experts chosen for the study are the ones who are the specialists on the insomnia treatment. So, the secondary purpose is to determine the effectiveness of TCM patter differentiation treatment for the patients with insomnia.
Study Type
OBSERVATIONAL
Enrollment
600
Individualized treatment includes anything no matter what kind of interventions, like medicine, herbs, acupuncture, massage, behaviour therapy, diet and exercise therapy. The TCM experts should choose the intervention in accordance to the patients' preference, best existed evidence and their empirical knowledge.
East Hospital of Beijing University of Traditional Chinese Medicine
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGGuang'anmen Hospital of China Academy of China Medical Sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGChange from baseline in the Sleep Quality
Measured by Pittsburgh Sleep Quality Index, PSQI
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the diagnosis of insomnia
Measured by the Structured Interview for Insomnia Disorder (SID), which is a translation and modified version of Brief Insomnia Questionnaire and used as a diagnosis questionnaire in the study. Its content validity has been reviewed and assessed by the experts who participated in the cohort. Three criteria of DSM-Ⅴ, ICSD-3 and ICD-10 for insomnia have been included in the SID questionnaire. The SID is chosen as an outcome to tell whether there is a diagnosis of insomnia after treatment.
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Insomnia Severity
Measured by Insomnia Severity Index, ISI
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Patient's satisfaction to the TCM treatment
Measured by the Patient's satisfaction scale
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Insomnia severity and improvement
Measured by the Clinician Global Impression Scale-Severity and -Improvement score.
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Clinician's satisfaction to the TCM treatment
Measured by the Clinician Reported Outcome for TCM treatment
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Reduction of western medicine
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Guang'anmen Hospital of China Academy of China Medical Sciences
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGGuang'anmen Hospital of China Academy of China Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGFujian Institute of Traditional Chinese Medicine
Fuzhou, Fujian, China
NOT_YET_RECRUITINGShenzhen hospital of Traditionl Chinese Medicine
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGAffiliated hospital of He'nan university of Traditional Chinese Medicine
Zhengzhou, Henan, China
RECRUITINGClinic of Hubei university of Traditional Chinese Medicine
Wuhan, Hubei, China
RECRUITINGAffiliated hospital of Shandong university of Traditional Chinese Medicine
Ji'nan, Shandong, China
NOT_YET_RECRUITINGReported by the patients.
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Sleep structure
Measured by the Cardiopulmonary Coupling (CPC), which is a new operator-independent, automated measure of sleep physiology. CPC collects the electrocortical activity of the heart rate variability (HRV) and respiration. The result provides information on sleep quality and sleep disordered breathing phenotypes independent of EEG analysis. High-frequency coupling states the consolidated and stable NREM sleep, and Low-frequency coupling is enhanced in states of fragmented sleep.
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Depression/Anxiety severity
Measured by the Hamilton Depression/Anxiety Scale
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Other measures that experts regard them necessary.
Other measures may include the wrist actigraphy, Polysomnography (PSG), other questionnaires, Multiple Sleep Latency Test (MSLT), CT, MRI, or some chemicals test.
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Adverse Event
Reported by the patients, such as cold, fever, diarrhea, and so on.
Time frame: Week 1, 2, 4, 6, 8 or Final visit.