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InsomniaNCT04141280

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

An observational study of Insomnia, run by China Academy of Chinese Medical Sciences.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Insomnia
How many people
180 participants
Where
No sites listed yet
Study dates
20 Oct 2019to 30 Oct 2021
How long will I take part?
7 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Adult, Older adult

Study population: After recruitment, subjects were collected from the clinic of China Academy of Chinese Medical Sciences and Xiyuan Hospital.

Who may be able to join

  • Insomnia group
  • Meets the diagnostic criteria for ICSD-3 chronic insomnia;
  • PSQI total score >16 points;
  • Age 18-80 years old;
  • Subjects agree with participate the research;
  • Meets diagnostic criteria for five syndrome types of Chinese medicine insomnia.
Show all 11Show fewer
  • Normal group:
  • Subjects had no insomnia or lacked of sleep in the past month.
  • Blood pressure, blood sugar, and blood lipids are normal;
  • Age 18-80 years old;
  • Subjects agree with participate the research.

Who cannot join

  • Insomnia group
  • Suffering from serious neurological and psychiatric diseases;
  • Suffering from systemic immune diseases, blood system diseases and obvious skin diseases;
  • Having obvious symptoms of coronary heart disease and cerebrovascular disease;
  • fMRI examination contraindications, including those who have undergone cardiac pacemaker implantation, those with grafts or metal foreign bodies, claustrophobia, etc.
  • Unable to complete the tester.
Show all 14Show fewer
  • Normal group:
  • PSQI total score ≥ 7 points；
  • People who have taken drugs that affect sleep in the past week.
  • Suffering from serious neurological and psychiatric diseases;
  • Suffering from systemic immune diseases, blood system diseases and obvious skin diseases;
  • Having obvious symptoms of coronary heart disease and cerebrovascular .
  • fMRI examination contraindications, including those who have undergone cardiac pacemaker implantation, those with grafts or metal foreign bodies, claustrophobia, etc.
  • Unable to complete the tester.

Trial locations and contacts

No sites are listed yet.

Yi Yu contact

18810216051

free-yy@outlook.com

About this study

Official title: Study on the Material Basis of Syndromes of Insomnia and the Correlation Between

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.

Read the 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.

Conditions
Insomnia
Keywords
Insomnia, Syndrome, Material basis, Infrared image, Relativity
Medical subject headings
Sleep Initiation and Maintenance Disorders, Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04141280
Study groupRoleWhat they receive
Insomnia groupAccording 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 groupAccording to the inclusion and exclusion criteria, 30 normal people were selected.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 20 minutes

  2. 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.

    Measured: 9hours

  3. fMRI

    Detecting brain excitation functional area blood oxygen concentration and comparing the difference between the two groups.

    Measured: 30 minutes

  4. 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.

    Measured: 9hours

  5. 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.

    Measured: 3 hours

Secondary outcomes (1)

  1. 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.

    Measured: 10minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2019
  2. Study start20 Oct 2019 (estimated)
  3. Primary completion20 Oct 2021 (estimated)
  4. Study completion30 Oct 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
180 participants (estimated)
Target duration
7 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT04141280
Sponsor's protocol ID
ZZ2018015
Status last verified
Oct 2019
First submitted
19 Oct 2019
Last updated
28 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified IPD for all primary and secondary outcome measures will be made available.

Publications

  • 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.

    PubMed 28847002

  • 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.

    PubMed 26799351

  • 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.

    PubMed 11404291

  • 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.

    PubMed 23523374

Questions about this trial

What is this clinical trial studying?

An observational study of Insomnia, run by China Academy of Chinese Medical Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yi Yu (18810216051, free-yy@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Four diagnostic information of Traditional Chinese Medicine(TCM) (time frame: 20 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04141280, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2019.

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