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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
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.
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.
Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University
Beijing, Beijing Municipality, China
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)
Time frame: baseline,12 weeks
Brain gray matter
The changes of gray matter volume in default network before and after treatment
Time frame: baseline,12 weeks
Total sleep time obtained by questionnaire:Pittsburgh Sleep Quality Index
Time frame: baseline,12 weeks
Sleep efficiency obtained by questionnaire:Pittsburgh Sleep Quality Index
Time frame: baseline,12 weeks
Sleep latency obtained by questionnaire:Pittsburgh Sleep Quality Index
Time frame: baseline,12 weeks
Wake after sleep onset obtained by questionnaire:Pittsburgh Sleep Quality Index
Time frame: baseline,12 weeks
Sleep problem obtained by questionnaire:Insomnia Severity Index
Time frame: baseline,12 weeks
Emotional state of anxiety obtained by questionnaire:Self-Rating Anxiety Scale
Time frame: baseline,12 weeks
Emotional state of depression obtained by questionnaire:Self-Rating Depression Scale
Time frame: baseline,12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Daytime function obtained by questionnaire:Epworth Sleepiness Score
Time frame: baseline,12 weeks
Daytime function obtained by questionnaire:Flinders Fatigue Scale
Time frame: baseline,12 weeks
resting-state functional magnetic resonance imaging
Resting state intrinsic connectivity within the default network by MRI
Time frame: baseline,12 weeks