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Experimental Research Center of China Academy of Chinese Medical Sciences

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ClinicalTrials.gov Identifier: NCT03459950
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
Jun Song, China Academy of Chinese Medical Sciences

Brief Summary:

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.


Condition or disease
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
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: China Academy of Chinese Medical Sciences
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

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.



Primary Outcome Measures :
  1. Infrared image [ Time Frame: 2019.9 ]
    Observed subjects in various regions or regions hot △T, which is the average temperature difference between body and body surface



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459950


Contacts
Contact: Song Jun 010-64089569 yxsyzx0000@sina.com
Contact: Shan Zengyu 010-64089512 yxsyzx0000@sina.com

Locations
China, Beijing
Experimental Research Center of China Academy of Chinese Medical Sciences Recruiting
Beijing, Beijing, China, 100000
Contact: SONG Jun         
Sponsors and Collaborators
Jun Song

Responsible Party: Jun Song, Researcher, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03459950     History of Changes
Other Study ID Numbers: Jun Song
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No