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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insomnia group | 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 | According to the inclusion and exclusion criteria, 30 normal people were selected. |
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| Measure | Description | Time Frame |
|---|---|---|
| Four diagnostic information of Traditional Chinese Medicine(TCM) | All subjects filled in the form about the four diagnostic information of TCM in order to observe the subject's symptoms and judge the syndrome. | 20 minutes |
| polysomnography | All 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. | 9hours |
| fMRI | Detecting brain excitation functional area blood oxygen concentration and comparing the difference between the two groups. | 30 minutes |
| Neuroactive substance detection | Blood is taken once before bedtime and the next morning in order to detect neuroactive substance,such as GABA,Glu,NE and so on. | 9hours |
| Infrared image | All 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. | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh sleep quality index | Pittsburgh 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. | 10minutes |
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Inclusion Criteria:
Insomnia group
Normal group:
Exclusion Criteria:
Insomnia group
Normal group:
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After recruitment, subjects were collected from the clinic of China Academy of Chinese Medical Sciences and Xiyuan Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi Yu | Contact | 18810216051 | free-yy@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Hongtao Lei | Eperimental Research Center,China Academy of Chinese Medical Sciences | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28847002 | Background | Liu K, Kim J, Kim DW, Zhang YS, Bao H, Denaxa M, Lim SA, Kim E, Liu C, Wickersham IR, Pachnis V, Hattar S, Song J, Brown SP, Blackshaw S. Lhx6-positive GABA-releasing neurons of the zona incerta promote sleep. Nature. 2017 Aug 31;548(7669):582-587. doi: 10.1038/nature23663. Epub 2017 Aug 23. | |
| 26799351 | Background |
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De-identified IPD for all primary and secondary outcome measures will be made available.
Data will be available within 6 months of study completion.
Data access requests will be reviewed by an external Independent Review Panel.Requestors will be required to sign a Data Access Agreement.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D013577 | Syndrome |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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the whole blood
| Blackmer AB, Feinstein JA. Management of Sleep Disorders in Children With Neurodevelopmental Disorders: A Review. Pharmacotherapy. 2016 Jan;36(1):84-98. doi: 10.1002/phar.1686. |
| 11404291 | Background | Manfridi A, Brambilla D, Mancia M. Sleep is differently modulated by basal forebrain GABA(A) and GABA(B) receptors. Am J Physiol Regul Integr Comp Physiol. 2001 Jul;281(1):R170-5. doi: 10.1152/ajpregu.2001.281.1.R170. |
| 23523374 | Background | Basner M, Rao H, Goel N, Dinges DF. Sleep deprivation and neurobehavioral dynamics. Curr Opin Neurobiol. 2013 Oct;23(5):854-63. doi: 10.1016/j.conb.2013.02.008. Epub 2013 Mar 20. |
| D001523 |
| Mental Disorders |
| D004194 | Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |