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Primary InsomniaPhase 1NCT02448602

Different Acupoints Compatibility Difference of the Effect of Treatment of the Primary Insomnia

A Phase 1 study testing acupuncture in people with Primary Insomnia, run by Changchun University of Chinese Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

With primary insomnia as the research object, by the method of multi-center RCT and needle single cavity and different acupoints compatibility treatment for primary insomnia, to Pittsburgh sleep quality index(PSQI) and evaluation, sleep log evaluation and Polysomnogram(PSG) as the means, such as the single cavity with… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Primary Insomnia
What is being tested?
acupuncture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
333 participants
Where
1 siteChina
Study dates
Jan 2015to Aug 2018
Phase
Phase 1
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Clinical diagnosis of Insomnia 's Disease;
  • Aged 18-60 (including 18 and 60);
  • Does not attend other clinical researchers;
  • Participation in the researchers signed informed consent and voluntary;
  • Pittsburgh sleep index (PSQI) index > 7 points;
  • Athens scale or 6 points;
  • Depression scale and anxiety scale 50 points or less.

Who cannot join

  • Breathing-Related Sleep disorder;
  • Circadian rhythm disorders;
  • Sleep disorders;
  • Drug-induced insomnia (such as drug abuse, drug treatment);
  • Sleep disorders caused by poor diet, lifestyle factors(Long-term excessive drinking, coffee, tea, etc.);
  • All systemic diseases (such as pain, fever, cough, surgery, etc.) and the external environment disturbance factors;
Show all 14Show fewer
  • With cardiovascular, lung, liver, kidney and hematopoietic system such as serious primary diseases;
  • Patients with mental illness;
  • Pregnancy or breast-feeding women;
  • Acupoints with severe skin infections;
  • Patients who are afraid of acupuncture;
  • Advanced malignant tumor or other serious wasting disease, infection and bleeding;
  • Who do not meet the inclusion criteria, poor compliance, treatment, not according to stipulations can not judge the curative effect or data not congruent affect curative effect and safety of judgment;
  • Caused by excessive anxiety and depression of patients with insomnia.

Trial locations and contacts

1 site in 1 country.

Tie Li, Ph.D contact

+86 0431 86714973

zusanli_1999@126.com

China1 site, 1 recruiting

  • The Affiliated Hospital To Changchun University of Chinese Medicine

    Changchun, Jilin, 130117

    Tie Li, Ph.D, +86 0431 86714973, zusanli_1999@126.com

    Recruiting

Other trials in China

About this study

Official title: Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect

With primary insomnia as the research object, by the method of multi-center RCT and needle single cavity and different acupoints compatibility treatment for primary insomnia, to Pittsburgh sleep quality index(PSQI) and evaluation, sleep log evaluation and Polysomnogram(PSG) as the means, such as the single cavity with different acupoints compatibility evaluate clinical curative effect of treating primary insomnia.

Read the detailed description

In order to establish a spectrum of acupoints compatibility of the law, is clear about the factors affecting the compatibility effect of acupoints, the formation of strong operability of acupoints compatibility optimization evaluation method, the project choice of the clinical acupuncture and moxibustion have curative effect of primary insomnia as the breakthrough point of the study, carried out clinical multi-center RCT research, through objective and scientific evaluation method, comparing the effect of different acupoints compatibility.

Primary insomnia in clinical common disease, frequently-occurring disease, acupuncture curative effect is distinct, disease diagnosis, curative effect evaluation standard. Previous clinical data also show that the primary insomnia is acupuncture clinical diseases. This project by primary insomnia as the research object, research to better guide clinical practice, improve the clinical curative effect, promote acupuncture of the inheritance and innovation, promote scientification of acupuncture and moxibustion, modernization and internationalization, and will have broad prospect of application and significant scientific research value.

Being tested
acupuncture
Keywords
Different acupoints compatibility
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.

  • acupunctureOther

    Patients will be treated with Shenmen(HT7), needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.

  • acupunctureOther

    Patients in Sancai coordinated points group, will be treated with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6), needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.

  • acupunctureOther

    Patients in Control group, will be treated with at the junction of deltoid and biceps, needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.

Study groups in NCT02448602
Study groupRoleWhat they receive
Single point group (Shenmen)OtherPatients will be acupuncture with Shenmen(HT7).
Receives: Other: acupuncture
Sancai coordinated points groupOtherPatients in Sancai coordinated points group, will be acupuncture with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6).
Receives: Other: acupuncture
Control groupOtherPatients in Control group, will be acupuncture with at the junction of deltoid and biceps.
Receives: Other: acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pittsburgh sleep quality index(PSQI)

    Measured: 9 weeks

Secondary outcomes (6)

  1. Test GABA,Glu,5-HT,Ach,NE,DA in the human brain to reflect the state of brain function by the Encephalofluctuograph(ET)

    Measured: 5 weeks

  2. Change in Total Sleep Time Measured by PSG

    Measuring indexes including total record time(TRT), sleep time(SPT), total sleep time(TST, sleep efficiency, sleep latency(SL), sleep cycle changes, awakening times, fall asleep after waking hours, REM times incubation period, incubation period of REM, REM (except the awakening times).

    Measured: 5 weeks

  3. Sleep diary

    Measured: 5 weeks

  4. Athens insomnia scale

    Measured: 9 weeks

  5. Self-rating anxiety scale(SAS)

    Measured: 1 week

  6. Self-Rating Depression Scale(SDS)

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2017 (estimated)
  4. Study completionAug 2018 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
333 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02448602
Sponsor's protocol ID
ChangchunUCM
Status last verified
May 2015
First submitted
14 Apr 2015
Last updated
21 May 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Ha L, Liu X, Liu Y, Zhi M, Jiang H, Zhao J, Wang Y, Xu X, Guo L, Cao J, Chen L, Yuan Y, Li T, Wang F. Scheme optimization of acupoints compatibility and influence factors of the effect. Medicine (Baltimore). 2021 Dec 17;100(50):e27883. doi: 10.1097/MD.0000000000027883.

    PubMed 34918637

  • Shi XH, Wang YK, Li T, Liu HY, Wang XT, Wang ZH, Mang J, Xu ZX. Gender-related difference in altered fractional amplitude of low-frequency fluctuations after electroacupuncture on primary insomnia patients: A resting-state fMRI study. Brain Behav. 2021 Jan;11(1):e01927. doi: 10.1002/brb3.1927. Epub 2020 Nov 4.

    PubMed 33146953

  • Wang YK, Li T, Ha LJ, Lv ZW, Wang FC, Wang ZH, Mang J, Xu ZX. Effectiveness and cerebral responses of multi-points acupuncture for primary insomnia: a preliminary randomized clinical trial and fMRI study. BMC Complement Med Ther. 2020 Aug 17;20(1):254. doi: 10.1186/s12906-020-02969-6.

    PubMed 32807158

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing acupuncture in people with Primary Insomnia, run by Changchun University of 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 7 inclusion and 14 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 21 May 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Tie Li, Ph.D (+86 0431 86714973, zusanli_1999@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pittsburgh sleep quality index(PSQI) (time frame: 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02448602, which also lists 3 linked publications.

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 21 May 2015.

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