Status:
UNKNOWN
Acupuncture Regulates Default Mode Network of Chronic Insomnia Disorder Patients : A fMRI Study
Lead Sponsor:
Beijing Hospital of Traditional Chinese Medicine
Conditions:
Chronic Insomnia
Eligibility:
All Genders
30-60 years
Phase:
NA
Brief Summary
The purpose of the study is to investigate the underlying central nervous mechanisms of acupuncture treatment in chronic insomnia patients, from observation changes of gray matter and functional conne...
Detailed Description
Chronic insomnia which can cause daytime function impairments like abnormal emotion and hypomnesis is important risk factors for developing cardiovascular disease, neurological disorders or mental dis...
Eligibility Criteria
Inclusion
- Insomnia group: Patients must meet DSM V criteria for chronic insomnia. PSQI\>7 、ISI\>7、 SAS\<50、 SDS\<50.
- control group: no self-reported sleep problems in the last 1 months. PSQI≤5 、SAS\<50、 SDS\<50，MMSE≥27.
- 30-60 years old.
- Male or female.
- Dextromanuality.
- Having given written informed consent to participate in the research project.
Exclusion
- History of cardiovascular and respiratory diseases.
- Other diagnoses of the nerve or mental disorders.
- Other sleep disorders.
- The long history of smoking, drinking and abusing drugs, or taking psychotropic drugs in last month, and treatment in other clinical trials at the same time.
- The body carrying pacemakers, defibrillators, implantable vascular clamp, implantable electric or magnetic device, mechanical heart valve, artificial cochlear, el., fMRI taboo and the claustrophobic.
- MRI scans have been used to identify patients with a definite organic lesion or severe head anatomical asymmetry
- Pregnancy, lactation and peri menopausal women.
- An allergy history of syncope, alcohol, and metal needle.
- The body Mass Index\>32 or \<19.8.
Key Trial Info
Start Date :
February 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 28 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03386903
Start Date
February 28 2018
End Date
June 28 2019
Last Update
December 29 2017
Active Locations (1)
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1
Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University
Beijing, Beijing Municipality, China, 100000