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

Chronic Insomnia Clinical Trial

Official title:

Acupuncture Regulates Emotion-cognitive Network of Chronic Insomnia Patients : A DTI-fMRI Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03386903
• Other study ID #: 2016BL-033-01
• Status: Not yet recruiting
• Phase: N/A
• First received: August 9, 2017
• Last updated: December 21, 2017
• Start date: February 28, 2018
• Est. completion date: June 28, 2019

Study information

• Verified date: December 2017
• Source: Beijing Hospital of Traditional Chinese Medicine
• Contact: Liu c zhi, M.D
• Phone: 010-52176043
• Email: lcz623780[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 28, 2019
• Est. primary completion date: December 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Brain gray matter	The changes of gray matter volume in default network before and after treatment	baseline,12 weeks
Secondary	Total sleep time obtained by questionnaire:Pittsburgh Sleep Quality Index		baseline,12 weeks
Secondary	Sleep efficiency obtained by questionnaire:Pittsburgh Sleep Quality Index		baseline,12 weeks
Secondary	Sleep latency obtained by questionnaire:Pittsburgh Sleep Quality Index		baseline,12 weeks
Secondary	Wake after sleep onset obtained by questionnaire:Pittsburgh Sleep Quality Index		baseline,12 weeks
Secondary	Sleep problem obtained by questionnaire:Insomnia Severity Index		baseline,12 weeks
Secondary	Emotional state of anxiety obtained by questionnaire:Self-Rating Anxiety Scale		baseline,12 weeks
Secondary	Emotional state of depression obtained by questionnaire:Self-Rating Depression Scale		baseline,12 weeks
Secondary	Daytime function obtained by questionnaire:Epworth Sleepiness Score		baseline,12 weeks
Secondary	Daytime function obtained by questionnaire:Flinders Fatigue Scale		baseline,12 weeks
Secondary	resting-state functional magnetic resonance imaging	Resting state intrinsic connectivity within the default network by MRI	baseline,12 weeks