Clinical trial NCT03386903: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Insomnia
Lead sponsor: Beijing Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Sleep quality obtained by questionnaire:Pittsburgh Sleep Quality Index
timeFrame: baseline,12 weeks
Secondary outcomes:
measure: Brain gray matter
timeFrame: baseline,12 weeks
measure: Total sleep time obtained by questionnaire:Pittsburgh Sleep Quality Index
timeFrame: baseline,12 weeks
measure: Sleep efficiency obtained by questionnaire:Pittsburgh Sleep Quality Index
timeFrame: baseline,12 weeks
measure: Sleep latency obtained by questionnaire:Pittsburgh Sleep Quality Index
timeFrame: baseline,12 weeks
measure: Wake after sleep onset obtained by questionnaire:Pittsburgh Sleep Quality Index
timeFrame: baseline,12 weeks
measure: Sleep problem obtained by questionnaire:Insomnia Severity Index
timeFrame: baseline,12 weeks
measure: Emotional state of anxiety obtained by questionnaire:Self-Rating Anxiety Scale
timeFrame: baseline,12 weeks
measure: Emotional state of depression obtained by questionnaire:Self-Rating Depression Scale
timeFrame: baseline,12 weeks
measure: Daytime function obtained by questionnaire:Epworth Sleepiness Score
timeFrame: baseline,12 weeks
measure: Daytime function obtained by questionnaire:Flinders Fatigue Scale
timeFrame: baseline,12 weeks
measure: resting-state functional magnetic resonance imaging
timeFrame: baseline,12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University
state: Beijing
Study officials:
affiliation: Beijing Hospital of Traditional Chinese Medicine
name: Liu cun zhi, M.D
role: STUDY_DIRECTOR
References: