Experimental Research Center of China Academy of Chinese Medical Sciences

NCT03459950 | Unknown

• 1 other identifier: Jun Song
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Chronic

Outcome Measures

Primary Outcomes (1)

• Infrared image

  Observed subjects in various regions or regions hot △T, which is the average temperature difference between body and body surface

  2019.9

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

Sponsors & Collaborators

• Jun Song: lead

Study Sites (1)

Experimental Research Center of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Song Jun

CONTACT

010-64089569; yxsyzx0000@sina.com

Shan Zengyu

CONTACT

010-64089512; yxsyzx0000@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 9, 2018
• Study Start: March 15, 2018
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 31, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)