Chronic InsomniaNCT03386903
Acupuncture Regulates Default Mode Network of Chronic Insomnia Disorder Patients : A fMRI Study
A study testing Ture acupuncture in people with Chronic Insomnia, run by Beijing Hospital of Traditional Chinese Medicine at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Ture acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2018to 28 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy, lactation and peri menopausal women.
- An allergy history of syncope, alcohol, and metal needle.
- The body Mass Index>32 or <19.8.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Hostipal of Traditional Chinese Medicine affiliated to Capital medical University
Beijing, Beijing Municipality, 100000
About this study
Official title: Acupuncture Regulates Emotion-cognitive Network of Chronic Insomnia Patients : A DTI-fMRI Study
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.
Read the 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.
- Conditions
- Chronic Insomnia
- Being tested
- Ture acupuncture, Sham acupuncture
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ture acupunctureDevice
Also called Experimental
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 acupunctureDevice
Also called Placebo Comparator
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham acupuncture |
| Healthy group | No intervention | Healthy subjects without intervention except scanned brain image by MRI at the baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline,12 weeks
Secondary outcomes (11)
Brain gray matter
The changes of gray matter volume in default network before and after treatment
Measured: baseline,12 weeks
Total sleep time obtained by questionnaire:Pittsburgh Sleep Quality Index
Measured: baseline,12 weeks
Sleep efficiency obtained by questionnaire:Pittsburgh Sleep Quality Index
Measured: baseline,12 weeks
Sleep latency obtained by questionnaire:Pittsburgh Sleep Quality Index
Measured: baseline,12 weeks
Wake after sleep onset obtained by questionnaire:Pittsburgh Sleep Quality Index
Measured: baseline,12 weeks
Sleep problem obtained by questionnaire:Insomnia Severity Index
Measured: baseline,12 weeks
Emotional state of anxiety obtained by questionnaire:Self-Rating Anxiety Scale
Measured: baseline,12 weeks
Emotional state of depression obtained by questionnaire:Self-Rating Depression Scale
Measured: baseline,12 weeks
Daytime function obtained by questionnaire:Epworth Sleepiness Score
Measured: baseline,12 weeks
Daytime function obtained by questionnaire:Flinders Fatigue Scale
Measured: baseline,12 weeks
resting-state functional magnetic resonance imaging
Resting state intrinsic connectivity within the default network by MRI
Measured: baseline,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start28 Feb 2018 (estimated)
- Primary completion28 Dec 2018 (estimated)
- Study completion28 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping Zhou, Beijing Hospital of Traditional Chinese Medicine
- Investigators
- Liu cun zhi, M.D, Study director, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386903
- Sponsor's protocol ID
- 2016BL-033-01
- Status last verified
- Dec 2017
- First submitted
- 9 Aug 2017
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Regulates Emotion-cognitive Network of Chronic Insomnia Patients : A DTI-fMRI Study
- ClinicalTrials.gov ID
- NCT03386903
- Acronym / sponsor ID
- 2016BL-033-01
- Conditions
- Chronic Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beijing Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 28 Feb 2018 (estimated)
- Primary completion
- 28 Dec 2018 (estimated)
- Study completion
- 28 Jun 2019 (estimated)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ture acupuncture group | Experimental | Device: Ture acupunctureAfter 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. |
| Sham acupuncture group | Placebo comparator | Device: Sham acupunctureAfter 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. |
| Healthy group | No intervention | –Healthy subjects without intervention except scanned brain image by MRI at the baseline. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ture acupunctureAlso: ExperimentalPatients 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. | Device | Ture acupuncture group |
| Sham acupunctureAlso: Placebo ComparatorPatients 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. | Device | Sham acupuncture group |
Primary outcome
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)
11 secondary outcomes
Brain gray matter
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liu cun zhi, M.D study director
Beijing Hospital of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ture acupuncture in people with Chronic Insomnia, run by Beijing Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liu c zhi, M.D (010-52176043, lcz623780@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality obtained by questionnaire:Pittsburgh Sleep Quality Index (time frame: baseline,12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2017.