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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04141280
• Other study ID #: ZZ2018015
• Status: Not yet recruiting
• Start date: October 20, 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: October 2019
• Source: China Academy of Chinese Medical Sciences
• Contact: Yi Yu
• Phone: 18810216051
• Email: free-yy[@]outlook.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: October 30, 2021
• Est. primary completion date: October 20, 2021
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences

References & Publications (4)

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. Review. — View Citation

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. Review. — View Citation

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. Erratum in: Nature. 2017 Sep 27;:. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	fMRI	Detecting brain excitation functional area blood oxygen concentration and comparing the difference between the two groups.	30 minutes
Primary	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
Primary	Infrared image	All subjects were completely exposed to the body in a closed room and tested infrared imaging technology.Observing the thermal state ?T 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
Secondary	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