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Acupuncture Regulates Default Mode Network of Chronic Insomnia Disorder Patients : A fMRI Study

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ClinicalTrials.gov Identifier: NCT03386903
Recruitment Status : Not yet recruiting
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Ping Zhou, Beijing Hospital of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
Chronic Insomnia Device: Ture acupuncture Device: Sham acupuncture Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture Regulates Emotion-cognitive Network of Chronic Insomnia Patients : A DTI-fMRI Study
Estimated Study Start Date : February 28, 2018
Estimated Primary Completion Date : December 28, 2018
Estimated Study Completion Date : June 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Ture acupuncture group
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.
Device: Ture acupuncture
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.
Other Name: Experimental

Placebo Comparator: Sham acupuncture group
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.
Device: Sham acupuncture
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.
Other Name: Placebo Comparator

No Intervention: Healthy group
Healthy subjects without intervention except scanned brain image by MRI at the baseline.



Primary Outcome Measures :
  1. Sleep quality obtained by questionnaire:Pittsburgh Sleep Quality Index [ Time Frame: baseline,12 weeks ]
    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 :
  1. Brain gray matter [ Time Frame: baseline,12 weeks ]
    The changes of gray matter volume in default network before and after treatment

  2. Total sleep time obtained by questionnaire:Pittsburgh Sleep Quality Index [ Time Frame: baseline,12 weeks ]
  3. Sleep efficiency obtained by questionnaire:Pittsburgh Sleep Quality Index [ Time Frame: baseline,12 weeks ]
  4. Sleep latency obtained by questionnaire:Pittsburgh Sleep Quality Index [ Time Frame: baseline,12 weeks ]
  5. Wake after sleep onset obtained by questionnaire:Pittsburgh Sleep Quality Index [ Time Frame: baseline,12 weeks ]
  6. Sleep problem obtained by questionnaire:Insomnia Severity Index [ Time Frame: baseline,12 weeks ]
  7. Emotional state of anxiety obtained by questionnaire:Self-Rating Anxiety Scale [ Time Frame: baseline,12 weeks ]
  8. Emotional state of depression obtained by questionnaire:Self-Rating Depression Scale [ Time Frame: baseline,12 weeks ]
  9. Daytime function obtained by questionnaire:Epworth Sleepiness Score [ Time Frame: baseline,12 weeks ]
  10. Daytime function obtained by questionnaire:Flinders Fatigue Scale [ Time Frame: baseline,12 weeks ]
  11. resting-state functional magnetic resonance imaging [ Time Frame: baseline,12 weeks ]
    Resting state intrinsic connectivity within the default network by MRI



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386903


Contacts
Contact: Liu c zhi, M.D 010-52176043 lcz623780@126.com
Contact: zhou ping, Postgraduate Student 13261306969 hzyyzp@126.com

Locations
China, Beijing
Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University Not yet recruiting
Beijing, Beijing, China, 100000
Sponsors and Collaborators
Beijing Hospital of Traditional Chinese Medicine
Investigators
Study Director: Liu cun zhi, M.D Beijing Hospital of Traditional Chinese Medicine

Responsible Party: Ping Zhou, Principal Investigator, Beijing Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03386903     History of Changes
Other Study ID Numbers: 2016BL-033-01
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders