Clinical trial NCT04141280: Study on the Material Basis of Syndromes of Insomnia and the Correlation Between Infrared Image
Official title: Study on the Material Basis of Syndromes of Insomnia and the Correlation Between
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Insomnia
Keywords: Insomnia
Syndrome
Material basis
Infrared image
Relativity
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: After recruitment, subjects were collected from the clinic of China Academy of Chinese Medical Sciences and Xiyuan Hospital.

Brief summary: This study combined the insomnia syndrome with PSG, fMRI, neuroactive substance detection, and infrared heat map, observing the electrophysiological changes of insomnia patients with different syndromes,localizing brain function excitation zone and changes in neuroactive substances,and the response of the visceral function to the infrared Image，which reveal the biological material basis of insomnia syndrome, and analyze it's correlation with infrared Image, providing a scientific, objective and visual technical method for TCM diagnosis and treatment of insomnia.

Detailed description: Insomnia belongs to the category of "Bu Mei" in Traditional Chinese Medicine(TCM). Long-term insomnia can increase the risk of heart disease, high blood pressure, senile dementia, anxiety, and depression. Therefore, the insomnia sparked a heated discussion in medical research.

It has a good effect in treating insomnia with TCM,but there are problems such as strong subjectivity of syndrome differentiation and large difference in efficacy between doctors.

The previous study found that the infrared Image reflects the visceral function of insomnia patients to a certain extent.Modern studies have shown that insomnia is closely related to the dysfunction of functional coordination between the brain's sleep and the arousal center, and neuroactive substances played an important role on it."Syndrome" is the key of clinical diagnosis and treatment of TCM. Investigators believe that the central nervous system imbalance of different syndrome of insomnia has a certain correlation with the infrared Image.

Eligibility criteria: Inclusion Criteria:

* Insomnia group

  1. Meets the diagnostic criteria for ICSD-3 chronic insomnia;
  2. PSQI total score \>16 points;
  3. Age 18-80 years old;
  4. Subjects agree with participate the research;
  5. Meets diagnostic criteria for five syndrome types of Chinese medicine insomnia.
* Normal group:

  1. Subjects had no insomnia or lacked of sleep in the past month.
  2. Blood pressure, blood sugar, and blood lipids are normal;
  3. Age 18-80 years old;
  4. Subjects agree with participate the research.

Exclusion Criteria:

* Insomnia group

  1. Suffering from serious neurological and psychiatric diseases;
  2. Suffering from systemic immune diseases, blood system diseases and obvious skin diseases;
  3. Having obvious symptoms of coronary heart disease and cerebrovascular disease;
  4. fMRI examination contraindications, including those who have undergone cardiac pacemaker implantation, those with grafts or metal foreign bodies, claustrophobia, etc.
  5. Unable to complete the tester.
* Normal group:

  1. PSQI total score ≥ 7 points；
  2. People who have taken drugs that affect sleep in the past week.
  3. Suffering from serious neurological and psychiatric diseases;
  4. Suffering from systemic immune diseases, blood system diseases and obvious skin diseases;
  5. Having obvious symptoms of coronary heart disease and cerebrovascular .
  6. fMRI examination contraindications, including those who have undergone cardiac pacemaker implantation, those with grafts or metal foreign bodies, claustrophobia, etc.
  7. Unable to complete the tester.

Primary outcomes:
measure: Four diagnostic information of Traditional Chinese Medicine(TCM)
timeFrame: 20 minutes
measure: polysomnography
timeFrame: 9hours
measure: fMRI
timeFrame: 30 minutes
measure: Neuroactive substance detection
timeFrame: 9hours
measure: Infrared image
timeFrame: 3 hours
Secondary outcomes:
measure: Pittsburgh sleep quality index
timeFrame: 10minutes
Other outcomes:
Locations:
Study officials:
affiliation: Eperimental Research Center,China Academy of Chinese Medical Sciences
name: Hongtao Lei
role: STUDY_DIRECTOR
References:
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