Acupuncture Regulates Default Mode Network of Chronic Insomnia Disorder Patients : A fMRI Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03386903|
Recruitment Status : Not yet recruiting
First Posted : December 29, 2017
Last Update Posted : December 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Insomnia||Device: Ture acupuncture Device: Sham acupuncture||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
- 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)
- Brain gray matter [ Time Frame: baseline,12 weeks ]The changes of gray matter volume in default network before and after treatment
- 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 ]
- 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 [ Time Frame: baseline,12 weeks ]Resting state intrinsic connectivity within the default network by MRI
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
|Contact: Liu c zhi, M.Demail@example.com|
|Contact: zhou ping, Postgraduate Studentfirstname.lastname@example.org|
|Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University||Not yet recruiting|
|Beijing, Beijing, China, 100000|
|Study Director:||Liu cun zhi, M.D||Beijing Hospital of Traditional Chinese Medicine|