Individualized Treatment With Traditional Chinese Medicine for the Patients With Insomnia Disorder: a Cohort Study

Individualized Treatment With Traditional Chinese Medicine Pattern Differentiation for the Patients With Insomnia Disorder: a Cohort Study

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Other: individualized treatment

Detailed Description

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 (Anticipated): 600

Contacts and Locations

• Study Contact: Name: Liyun He, PhD; Phone Number: 2207 86-010-64014411; Email: hely3699@163.com
• Study Contact Backup: Name: Changhe Yu, Master; Phone Number: 2207 86-010-64014411; Email: Changhe.yu86@gmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Not yet recruiting
      • East Hospital of Beijing University of Traditional Chinese Medicine
      • Contact: Rongjuan Guo
    • Beijing, Beijing, China
      • Not yet recruiting
      • Guang'anmen Hospital of China Academy of China Medical Sciences
      • Contact: Jiangui Zhu
    • Beijing, Beijing, China
      • Recruiting
      • Guang'anmen Hospital of China Academy of China Medical Sciences
      • Contact: Yanjiao Liu
  • Fujian
    • Fuzhou, Fujian, China
      • Not yet recruiting
      • Fujian Institute of Traditional Chinese Medicine
      • Contact: Junshan Huang
  • Guangdong
    • Shenzhen, Guangdong, China
      • Not yet recruiting
      • Shenzhen hospital of Traditionl Chinese Medicine
      • Contact: Zhouke Guo
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Affiliated hospital of He'nan university of Traditional Chinese Medicine
      • Contact: Songling Wang
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Clinic of Hubei university of Traditional Chinese Medicine
  • Shandong
    • Ji'nan, Shandong, China
      • Not yet recruiting
      • Affiliated Hospital of Shandong University of Traditional Chinese Medicine
      • Contact: Xianghua Qi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with the diagnosis of insomnia, who come to the experts' clinic for treatment, will be invitated and included in his cohort.

Description

Inclusion Criteria:

1. Patients with the diagnosis of insomnia;
2. Patients' age between 18 and 65 years (18 and 65 years included);
3. Patients with the oral or written informed consent.

Exclusion Criteria:

1. Patients with any uncontrolled and severe diseases which cause insomnia will be excluded. the diseases may include heart disease (like angina, cardiac arrhythmias, heart failure, myocardial infarction), pulmonary disease (COPD, asthma), gastrointestinal disorders (stomach or duodenal ulcers, reflux disease), neurologic disorders (seizures, spastic torticollis, blepharospasm, dystonias, parkinson's disease, alzheimer's disease, dementia, sleep-disruptive headaches), head trauma (blow to the head with loss of consciousness, concussion), pain disorders (fibrositis/fibromyalgia, arthritis, muscle cramps, chronic low back pain, headaches), endocrine and metabolic disorders (thyroid disease, diabetes), kidney disease (kidney failure with dialysis, kidney stones) autoimmune disorders, cancer, and HIV/AIDS.
2. Psychopath with suicidal tendency;
3. Patients with pregnancy and lactation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

10

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Based on the first TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.	Other: individualized treatment; 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.
Cohort 2; Based on the second TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.	Other: individualized treatment; 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.
Cohort 3; Based on the third TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.	Other: individualized treatment; 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.
Cohort 4; Based on the fourth TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.	Other: individualized treatment; 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.
Cohort 5; Based on the fifth TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.	Other: individualized treatment; 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.
Cohort 6; Based on the sixth TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.	Other: individualized treatment; 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.
Cohort 7; Based on the seven TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.	Other: individualized treatment; 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.
Cohort 8; Based on the eighth TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.	Other: individualized treatment; 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.
Cohort 9; Based on the nineth TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.	Other: individualized treatment; 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.
Cohort 10; Based on the tenth TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.	Other: individualized treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the Sleep Quality	Measured by Pittsburgh Sleep Quality Index, PSQI	Week 1, 2, 4, 6, 8 or Final visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Insomnia Severity	Measured by Insomnia Severity Index, ISI	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	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.	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	Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Reduction of western medicine	Reported by the patients.	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.	Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Depression/Anxiety severity	Measured by the Hamilton Depression/Anxiety Scale	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.	Week 1, 2, 4, 6, 8 or Final visit.
Adverse Event	Reported by the patients, such as cold, fever, diarrhea, and so on.	Week 1, 2, 4, 6, 8 or Final visit.

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: National Natural Science Foundation of China

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: March 20, 2015
• First Submitted That Met QC Criteria: March 30, 2015
• First Posted (Estimate): March 31, 2015

Study Record Updates

• Last Update Posted (Estimate): March 31, 2015
• Last Update Submitted That Met QC Criteria: March 30, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Insomnia; cohort study; Traditional Chinese Medicine; herbal medicine; individualized treatment; TCM pattern differentiation
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: GZR81230086