Acupuncture Regulates Default Mode Network of Chronic Insomnia Disorder Patients : A fMRI Study
Primary Purpose
Chronic Insomnia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ture acupuncture
Sham acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Insomnia
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Ture acupuncture group
Sham acupuncture group
Healthy group
Arm Description
After recruiting, patients are assigned to the ture acupuncture group by randomization,and then receive ture acupuncture treatment. patients are scanned by MRI at the baseline and 3 month post-treatment respectively.
After recruiting, patients are assigned to the sham acupuncture group by randomization,and then receive sham acupuncture stimulation. patients are scanned by MRI at the baseline and 3 month post-treatment respectively.
Healthy subjects without intervention except scanned brain image by MRI at the baseline.
Outcomes
Primary Outcome Measures
Sleep quality obtained by questionnaire:Pittsburgh Sleep Quality Index
Change in Pittsburgh sleep quality index scores at the baseline and the end of 12 weeks stimulation with acupuncture.Minimum Score = 0 (good sleep); Maximum Score = 30 (disrupted sleep)
Secondary Outcome Measures
Brain gray matter
The changes of gray matter volume in default network before and after treatment
Total sleep time obtained by questionnaire:Pittsburgh Sleep Quality Index
Sleep efficiency obtained by questionnaire:Pittsburgh Sleep Quality Index
Sleep latency obtained by questionnaire:Pittsburgh Sleep Quality Index
Wake after sleep onset obtained by questionnaire:Pittsburgh Sleep Quality Index
Sleep problem obtained by questionnaire:Insomnia Severity Index
Emotional state of anxiety obtained by questionnaire:Self-Rating Anxiety Scale
Emotional state of depression obtained by questionnaire:Self-Rating Depression Scale
Daytime function obtained by questionnaire:Epworth Sleepiness Score
Daytime function obtained by questionnaire:Flinders Fatigue Scale
resting-state functional magnetic resonance imaging
Resting state intrinsic connectivity within the default network by MRI
Full Information
NCT ID
NCT03386903
First Posted
August 9, 2017
Last Updated
December 21, 2017
Sponsor
Beijing Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03386903
Brief Title
Acupuncture Regulates Default Mode Network of Chronic Insomnia Disorder Patients : A fMRI Study
Official Title
Acupuncture Regulates Emotion-cognitive Network of Chronic Insomnia Patients : A DTI-fMRI Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2018 (Anticipated)
Primary Completion Date
December 28, 2018 (Anticipated)
Study Completion Date
June 28, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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 connectivity in the default mode network and the salience network by functional magnetic resonance imaging, and combine with clinical efficacy assessment to analyze the association between the results of imaging and behavioristic.
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 disorders. Acupuncture is a widely recognized therapy to treat chronic insomnia in clinical practice. Previous researches presented that sleep-wake dysfunction of patients with chronic insomnia have strong correlation with abnormal of the default mode network and salience network. The project present acupuncture may improve sleep quality by adjusting the abnormal default mode network and the salience network in patients with chronic insomnia.
The investigators are assigned the ninety eligible participants in three groups: thirty chronic insomnia patients by true acupuncture treatment (Zhoushi coordinated points), thirty chronic insomnia patients by sham acupuncture stimulation (non-acupoint points) and thirty healthy subjects, Treatment will be given 3 times per week for 3 months. Additionally, two methods include functional magnetic resonance imaging (fMRI) and clinical scales evaluation as the outcome measures to evaluate the effectiveness and security of acupuncture. Outcomes will be evaluated at baseline and 3 month post-treatment.
The aim of this project is to investigate effect of acupuncture treatment on gray matter and functional connectivity of the default network and the salience network in chronic insomnia patients, and to analyze the association between sleep quality, emotion, day function with imaging results. The central nervous mechanisms underlying acupuncture treatment are discussed by this finding which may provide scientific basis for acupuncture treatment in chronic insomnia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ture acupuncture group
Arm Type
Experimental
Arm Description
After recruiting, patients are assigned to the ture acupuncture group by randomization,and then receive ture acupuncture treatment. patients are scanned by MRI at the baseline and 3 month post-treatment respectively.
Arm Title
Sham acupuncture group
Arm Type
Placebo Comparator
Arm Description
After recruiting, patients are assigned to the sham acupuncture group by randomization,and then receive sham acupuncture stimulation. patients are scanned by MRI at the baseline and 3 month post-treatment respectively.
Arm Title
Healthy group
Arm Type
No Intervention
Arm Description
Healthy subjects without intervention except scanned brain image by MRI at the baseline.
Intervention Type
Device
Intervention Name(s)
Ture acupuncture
Other Intervention Name(s)
Experimental
Intervention Description
Patients receive true acupuncture treatment by Zhoushi coordinated points at the "Bai-hui" (DU20), "Shen-ting" (DU24), bilateral "Ben-shen" (BG13), "Shen-men" (HT7), "San-yin-jiao" (SP6) with "Deqi" sensation. The needles are retained for 20 minutes in every course, three times per week and last for 3 months.
Intervention Type
Device
Intervention Name(s)
Sham acupuncture
Other Intervention Name(s)
Placebo Comparator
Intervention Description
Patients receive sham acupuncture stimulation by non-acupoint points (superficial insertion, 0.2 cun, No needle sensation (de qi) is elicited) at the bilateral mid-point between Shuaigu(GB8) and Touwei(ST8), Touwei(ST8) and Yangbai(GB14), front tibia, the junction of biceps and triceps.
Primary Outcome Measure Information:
Title
Sleep quality obtained by questionnaire:Pittsburgh Sleep Quality Index
Description
Change in Pittsburgh sleep quality index scores at the baseline and the end of 12 weeks stimulation with acupuncture.Minimum Score = 0 (good sleep); Maximum Score = 30 (disrupted sleep)
Time Frame
baseline,12 weeks
Secondary Outcome Measure Information:
Title
Brain gray matter
Description
The changes of gray matter volume in default network before and after treatment
Time Frame
baseline,12 weeks
Title
Total sleep time obtained by questionnaire:Pittsburgh Sleep Quality Index
Time Frame
baseline,12 weeks
Title
Sleep efficiency obtained by questionnaire:Pittsburgh Sleep Quality Index
Time Frame
baseline,12 weeks
Title
Sleep latency obtained by questionnaire:Pittsburgh Sleep Quality Index
Time Frame
baseline,12 weeks
Title
Wake after sleep onset obtained by questionnaire:Pittsburgh Sleep Quality Index
Time Frame
baseline,12 weeks
Title
Sleep problem obtained by questionnaire:Insomnia Severity Index
Time Frame
baseline,12 weeks
Title
Emotional state of anxiety obtained by questionnaire:Self-Rating Anxiety Scale
Time Frame
baseline,12 weeks
Title
Emotional state of depression obtained by questionnaire:Self-Rating Depression Scale
Time Frame
baseline,12 weeks
Title
Daytime function obtained by questionnaire:Epworth Sleepiness Score
Time Frame
baseline,12 weeks
Title
Daytime function obtained by questionnaire:Flinders Fatigue Scale
Time Frame
baseline,12 weeks
Title
resting-state functional magnetic resonance imaging
Description
Resting state intrinsic connectivity within the default network by MRI
Time Frame
baseline,12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu c zhi, M.D
Phone
010-52176043
Email
lcz623780@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
zhou ping, Postgraduate Student
Phone
13261306969
Email
hzyyzp@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu cun zhi, M.D
Organizational Affiliation
Beijing Hospital of Traditional Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Acupuncture Regulates Default Mode Network of Chronic Insomnia Disorder Patients : A fMRI Study
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