Study on the Material Basis of Syndromes of Insomnia and the Correlation Between Infrared Image

China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Insomnia

Study type: Observational

Funder types: Other

Identifiers

NCT04141280

ZZ2018015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

180 participants in 2 patient groups

Insomnia group

Description:

According to the inclusion and exclusion criteria, 150 patients with insomnia were selected, which were divided into five groups: liver stagnation fire syndrome, phlegm heat syndrome, yin deficiency fire dysfunction syndrome, heart spleen deficiency syndrome and heart deficiency biliary syndrome.

Normal group

Description:

According to the inclusion and exclusion criteria, 30 normal people were selected.