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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04141280
Enrollment
180
Registered
2019-10-28
Start date
2019-10-20
Completion date
2021-10-30
Last updated
2019-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

Insomnia, Syndrome, Material basis, Infrared image, Relativity

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.

Interventions

None listed

Sponsors

China Academy of Chinese Medical Sciences
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Four diagnostic information of Traditional Chinese Medicine(TCM)20 minutesAll subjects filled in the form about the four diagnostic information of TCM in order to observe the subject's symptoms and judge the syndrome.
polysomnography9hoursAll subjects wore the polysomnography monitor electrodes and the data were record.According to physiological signal,observing the sleep structure and comparing the difference between the two groups.
fMRI30 minutesDetecting brain excitation functional area blood oxygen concentration and comparing the difference between the two groups.
Neuroactive substance detection9hoursBlood is taken once before bedtime and the next morning in order to detect neuroactive substance,such as GABA,Glu,NE and so on.
Infrared image3 hoursAll subjects were completely exposed to the body in a closed room and tested infrared imaging technology.Observing the thermal state ΔT of each location or region of the subject, that is, the difference between the temperature of the trunk heat map and the mean temperature of the body surface.

Secondary

MeasureTime frameDescription
Pittsburgh sleep quality index10minutesPittsburgh sleep quality index(PSQI)is used to evaluate sleep quality of subjects.It's maximum is 21.The higher the score, the worse the sleep quality.

Contacts

Primary ContactYi Yu
free-yy@outlook.com18810216051

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026