Experimental Research Center of China Academy of Chinese Medical Sciences

China Academy of Chinese Medical Sciences

Insomnia belongs to the category of"sleepless"in Chinese medicine. Sleepless is defined as a persistent sleep disorder, results in some form of daytime impairment.

Traditional Chinese medicine(TCM) has obvious advantages in the treatment of chronic insomnia, but there have some subjective and objective obstacles in the advantages of TCM treatment of replication, promotion, and popularization. Therefore, it is necessary to carry out the research from a multi-angle, and further summarize the ideas and methods from the perspective of TCM, to make it more objective, visual and standardized.

Insomnia is a clinical manifestation of the disorders of the Zang and Fu, and it can further aggravate the dysfunction of the Zang and Fu. The Traditional Chinese medicine believes that, outward is the internal manifestation. Infrared image can reflect the state of cold and heat, yin and yang in all parts of human body. So it is called the CT of TCM. Pre-study found that patients with sleep disorders have different infrared image than normal changes. Polysomnography is currently recognized as the golden indicator of sleep research. Polysomnography can monitor the whole sleep process, and study the sleep structure by the related indexes, which is a basic technique for Sleep medical research and diagnosis of sleep disorders, and a standard method of evaluating sleep-related pathophysiology and sleep architecture. We will study the relationship between sleep structure of the PSG, the characteristics of infrared image, the four diagnostic information of TCM, and the self-rating scales of sleep and psychology in patients with chronic insomnia.

Study Overview

• Status: Unknown
• Conditions: Insomnia Chronic

Detailed Description

Insomnia is a clinical manifestation of the disorders of the Zang and Fu, and it can further aggravate the dysfunction of the Zang and Fu. The Traditional Chinese medicine believes that, outward is the internal manifestation. Infrared image can reflect the state of cold and heat, yin and yang in all parts of human body. So it is called the CT of TCM. Pre-study found that patients with sleep disorders have different infrared image than normal changes. Polysomnography is currently recognized as the golden indicator of sleep research. Polysomnography can monitor the whole sleep process, and study the sleep structure by the related indexes, which is a basic technique for Sleep medical research and diagnosis of sleep disorders, and a standard method of evaluating sleep-related pathophysiology and sleep architecture.

In order to further understand sleep disorders and improve the efficiency of Chinese medicinein treating sleep disorders. We will study the relationship between sleep structure of the PSG, the characteristics of infrared image, the four diagnostic information of TCM, and the self-rating scales of sleep and psychology in patients with chronic insomnia

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Song Jun; Phone Number: 010-64089569; Email: yxsyzx0000@sina.com
• Study Contact Backup: Name: Shan Zengyu; Phone Number: 010-64089512; Email: yxsyzx0000@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Recruiting
      • Experimental Research Center of China Academy of Chinese Medical Sciences
      • Contact: SONG Jun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

60 patients with sleep disorder are included in the sleep disorder group and 60 in the normal control group, men and women half, the age of 18-60 years old, signature to the Information for Patient.

Description

Chronic Insomnia group Inclusion criteria Chronic insomnia diagnosis consistent with the criteria of International Classification of Sleep Disorder, third version (ICSD-3), PSQI score is greater than 16, 18 to 60 years of age, written informed consent.

Exclusion criteria Sedative-hypnotic, antidepressant with sedative effect, atypical antipsychotic drugs that have been used in 7 days, patients with severe neurological and psychiatric disorders, with systemic immune diseases and significant skin diseases, and who is unable to test for various reasons.

Normal control group Inclusion criteria Subjects do not have chronic insomnia or insufficient of sleep near a month, normal level of blood pressure, blood sugar, and blood lipid, 18 to 60 years of age, written informed consent.

Exclusion criteria PSQI score is greater than 7, people who have been taken drugs that affect sleep in the past week, have obvious clinical symptoms of coronary heart disease and cerebrovascular disease, and have severe neurological and psychiatric disorders, systemic immune diseases, and who is unable to test for various reasons.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Chronic Insomnia group; 60 patients with chronic insomnia are included in the Chronic Insomnia group. Men and women half, the age of 18-60 years old, signature to the Information for Patient.
Normal control group; 60 normal people are included in the normal control group. Men and women half, the age of 18-60 years old, signature to the Information for Patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infrared image	Observed subjects in various regions or regions hot △T, which is the average temperature difference between body and body surface	2019.9

Collaborators and Investigators

• Sponsor: Jun Song

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): May 31, 2018
• Last Update Submitted That Met QC Criteria: May 29, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Jun Song

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No