Sleep Initiation and Maintenance DisordersAI-RCTNCT02594670
Acupuncture for Insomnia: a Randomized Controlled Trial
A study testing DU20 and HT7 combination, DU20 and SP6 combination and DU20 and SA combination in people with Sleep Initiation and Maintenance Disorders, run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine at 3 sites in China.
Trial summary
Selecting different acupoints as an combination of acupoints is a key factor to clinical efficacy of acupuncture. Different combinations of acupoints will generate different clinical efficacy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- DU20 and HT7 combination, DU20 and SP6 combination and DU20 and SA combination
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- 3 sitesChina
- Study dates
- Oct 2015to Aug 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,2013, American psychiatric association
- PSQI score >7
- AIS score ≥6
- SDS ≤60
- SAS ≤60
- Age between 18 and 65 years old
- Not involved in other clinical trial in the lasted 6 months before screening
- Have the ability to write the informed consent.
Who cannot join
- Breathing-related sleep disorders
- Circadian rhythm sleep-wake disorders
- Medication-induced sleep disorder
- Substance induced sleep disorders,such as alcohol, coffee, strong tea
- Secondary insomnia caused by systemic diseases or caused by external environment disturbance
- Pregnant or lactating women
Show all 11Show fewer
- Combined with serious cardiovascular, lung, liver, kidney, hematopoietic system, and mental diseases
- Advanced malignant tumor or other serious debilitating diseases
- Location of acupoints combined with infection and bleeding
- Declined to acupuncture
- Couldn't provide the written informed consent.
Trial locations and contacts
3 sites in 1 country.
Yan Wang contact
China3 sites
Second Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 410005
First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 410007
Hengyang hospital of Hunan University of Chinese Medicine
Hengyang, Hunan
Zenghui Yue, 624755064@qq.com
About this study
Official title: Acupuncture Based on Different Acupoints Combination for Insomnia: a Randomized Controlled Trial
Selecting different acupoints as an combination of acupoints is a key factor to clinical efficacy of acupuncture. Different combinations of acupoints will generate different clinical efficacy. So,the purpose of this study is to determine the different clinical efficacy among three types of combinations of acupoints in the treatment of primary insomnia.
- Being tested
- DU20 and HT7 combination, DU20 and SP6 combination, DU20 and SA combination
- Keywords
- acupoints, insomnia, acupuncture, randomized controlled trial
- 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.
DU20 and HT7 combinationOther
acupoints combination includes Baihui (DU20) and Shenmen(HT7),which was considered as the optimal clinical efficay among various combinations of acupoints.
DU20 and SP6 combinationOther
acupoints combination of Baihui (DU20) and Sanyinjiao (SP6), which should have some clinical efficay among various combinations of acupoints.
DU20 and SA combinationOther
Combination of Baihui (DU20) and a Sham acupoint (SA), which should have least clinical efficacy among these three types of acupoints combinations.
| Study group | Role | What they receive |
|---|---|---|
| DU20 and HT7 combination | Experimental | combination of two acupoints based on location and Heart meridian, including Baihui (DU20) and Shenmen(HT7). Receives: Other: DU20 and HT7 combination |
| DU20 and SP6 combination | Other | combination of two acupoints based on location and Spleen meridian, including Baihui (DU20) and Sanyinjiao(SP6). Receives: Other: DU20 and SP6 combination |
| DU20 and SA combination | Sham comparator | combination of local acupoint Baihui (DU20) and a sham acupoint (SA) not belonging to any regular meridian or acupoint. Receives: Other: DU20 and SA combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh sleep quality index (PSQI)
Measured: 4 weeks
Secondary outcomes (4)
Athens Insomnia Scale (AIS)
Measured: 4 weeks and 8 weeks
Short Form 36-item Health Survey(SF-36)
Measured: 4 weeks and 8 weeks
Self-anxiety scale (SAS)
Measured: 4 weeks and 8 weeks
Self-depression scale (SDS)
Measured: 4 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies 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
- 333 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Ministry of Science and Technology of the People´s Republic of China
- Responsible party
- Sponsor
- Investigators
- Zenghui Yue, Study chair, Hunan University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594670
- Sponsor's protocol ID
- 2014CB543102-1
- Acronym
- AI-RCT
- Status last verified
- Mar 2015
- First submitted
- 30 Sep 2014
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Based on Different Acupoints Combination for Insomnia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02594670
- Acronym / sponsor ID
- AI-RCT / 2014CB543102-1
- Keywords
- acupoints, insomnia, acupuncture, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 333 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- University of British Columbia, Ministry of Science and Technology of the People´s Republic of China
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- 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.
Selecting different acupoints as an combination of acupoints is a key factor to clinical efficacy of acupuncture. Different combinations of acupoints will generate different clinical efficacy. So,the purpose of this study is to determine the different clinical efficacy among three types of combinations of acupoints in the treatment of primary 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 |
|---|---|---|
| DU20 and HT7 combination | Experimental | Other: DU20 and HT7 combinationcombination of two acupoints based on location and Heart meridian, including Baihui (DU20) and Shenmen(HT7). |
| DU20 and SP6 combination | Other | Other: DU20 and SP6 combinationcombination of two acupoints based on location and Spleen meridian, including Baihui (DU20) and Sanyinjiao(SP6). |
| DU20 and SA combination | Sham comparator | Other: DU20 and SA combinationcombination of local acupoint Baihui (DU20) and a sham acupoint (SA) not belonging to any regular meridian or acupoint. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed as insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition,2013, American psychiatric association
- PSQI score >7
- AIS score ≥6
- SDS ≤60
- SAS ≤60
Key exclusion criteria (11 listed)
- Breathing-related sleep disorders
- Circadian rhythm sleep-wake disorders
- Medication-induced sleep disorder
- Substance induced sleep disorders,such as alcohol, coffee, strong tea
- Secondary insomnia caused by systemic diseases or caused by external environment disturbance
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 |
|---|---|---|
| DU20 and HT7 combinationacupoints combination includes Baihui (DU20) and Shenmen(HT7),which was considered as the optimal clinical efficay among various combinations of acupoints. | Other | DU20 and HT7 combination |
| DU20 and SP6 combinationacupoints combination of Baihui (DU20) and Sanyinjiao (SP6), which should have some clinical efficay among various combinations of acupoints. | Other | DU20 and SP6 combination |
| DU20 and SA combinationCombination of Baihui (DU20) and a Sham acupoint (SA), which should have least clinical efficacy among these three types of acupoints combinations. | Other | DU20 and SA combination |
Primary outcome
Pittsburgh sleep quality index (PSQI)
Time frame: 4 weeks
4 secondary outcomes
Athens Insomnia Scale (AIS)
Time frame: 4 weeks and 8 weeks
Short Form 36-item Health Survey(SF-36)
Time frame: 4 weeks and 8 weeks
Self-anxiety scale (SAS)
Time frame: 4 weeks and 8 weeks
Self-depression scale (SDS)
Time frame: 4 weeks and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2015.
Related trials for Sleep Initiation and Maintenance Disorders
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Impact Of Aerobic Exercise on Sleep Quality and Postural Control Interplay Among University Students
Healthy Individuals
Not yet recruitingObservational study
FLOW: Influence of the Menstrual Cycle on Alcohol Use in Women
Alcohol Use, Alcohol Consumption
Active, not recruiting
Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults
Sleep Quality, Magnesium Deficiency
Not yet recruiting
Effects of Connective Tissue Massage in Patients With Chronic Insomnia
Chronic Insomnia
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.
Yan Wang contact
Zenghui Yue study chair
Hunan University of Chinese Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DU20 and HT7 combination, DU20 and SP6 combination and DU20 and SA combination in people with Sleep Initiation and Maintenance Disorders, run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine at 3 sites 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 8 inclusion and 11 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 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Yan Wang (48770045@qq.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: 4 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 3 Nov 2015.