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

NCT03386903 | Unknown DMC

• 1 other identifier: 2016BL-033-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Insomnia

Outcome Measures

Primary Outcomes (1)

• 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)

  baseline,12 weeks

Secondary Outcomes (11)

• Brain gray matter

  baseline,12 weeks

• Total sleep time obtained by questionnaire:Pittsburgh Sleep Quality Index

  baseline,12 weeks

• Sleep efficiency obtained by questionnaire:Pittsburgh Sleep Quality Index

  baseline,12 weeks

• Sleep latency obtained by questionnaire:Pittsburgh Sleep Quality Index

  baseline,12 weeks

• Wake after sleep onset obtained by questionnaire:Pittsburgh Sleep Quality Index

  baseline,12 weeks

Study Arms (3)

Ture acupuncture group

EXPERIMENTAL

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

Sham acupuncture group

PLACEBO COMPARATOR

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

Healthy group

NO INTERVENTION

Healthy subjects without intervention except scanned brain image by MRI at the baseline.

Interventions

Ture acupuncture DEVICE

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.

Also known as: Experimental

Ture acupuncture group

Sham acupuncture DEVICE

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.

Also known as: Placebo Comparator

Sham acupuncture group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• years old.
• Male or female.
• Dextromanuality.
• Having given written informed consent to participate in the research project.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Liu cun zhi, M.D

  Beijing Hospital of Traditional Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Liu c zhi, M.D

CONTACT

010-52176043; lcz623780@126.com

zhou ping, Postgraduate Student

CONTACT

13261306969; hzyyzp@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: December 29, 2017
• Study Start: February 28, 2018
• Primary Completion: December 28, 2018
• Study Completion: June 28, 2019
• Last Updated: December 29, 2017

Record last verified: 2017-12

Locations

CN (1)