Primary InsomniaNCT06782815
Acupoint Selection Based on Meridian Theory in Primary Insomnia of Liver Depression and Spleen Deficiency Type
A study testing Acupuncture in people with Primary Insomnia, run by Chuanlong Zhou at 1 site in China.
Trial summary
The classical literature combined with modern medicine to select acupoints, in order to intervene in the autonomic nerve function of the superior cervical sympathetic ganglion as an opportunity, put forward the meridian acupoints mainly to reconcile the head orifices Ying Wei, acupuncture treatment of primary insomnia… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- In line with the diagnostic criteria of insomnia of liver depression and spleen deficiency type in traditional Chinese medicine :
- In line with the Western diagnostic criteria for insomnia ;
- 18 ≤ age ≤ 40 years old, male or female ;
- patients with a course of more than two weeks ; Note: The above criteria must be met for inclusion in this study.
Who cannot join
- Insomnia caused by a variety of organic diseases, neurological or psychiatric disorders
- Pregnancy, lactation or drug allergy
- There are more serious primary diseases such as cardiovascular and cerebrovascular diseases, gastrointestinal diseases, endocrine system diseases, or psychiatric patients.
- Patients with coagulation dysfunction and bleeding tendency.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 321000
Zhou CL Zhou Chuanlong, 15868486255, 471388079@qq.com
About this study
Official title: Study on the Curative Effect and Autonomic Nerve Function of Primary Insomnia Patients with Liver Depression and Spleen Deficiency Type Based on Acupoint Selection of Meridian Theory
The classical literature combined with modern medicine to select acupoints, in order to intervene in the autonomic nerve function of the superior cervical sympathetic ganglion as an opportunity, put forward the meridian acupoints mainly to reconcile the head orifices Ying Wei, acupuncture treatment of primary insomnia clinical research. Heart rate variability ( HRV ), Pittsburgh sleep quality index ( PSQI ), polysomnography ( PSG ) and the MOS item short from health survey ( SF-36 ) were observed. Insomnia Severity Index ( ISI ), Dysfunctional Beliefs and Attitudes about Sleep Scale 16 ( DBAS-16 ), GABA, Glx and other secondary indicators were used to clarify the clinical short-term and long-term efficacy of different acupoints in the treatment of patients with primary insomnia and the intervention effect on HRV.
Read the detailed description
In this randomized controlled trial, 96 patients with insomnia of liver depression and spleen deficiency type were selected from the Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine. All patients will be randomly assigned to the control group or the acupuncture group.
MAIN OUTCOME MEASURES : Pittsburgh Sleep Quality Index ( PSQI ) was used to measure sleep quality, and 36-Item Short Form Health Survey ( SF-36 ) was used to measure quality of life. Secondary outcomes included the Insomnia Severity Index ( ISI ), Sleep Dysfunction Beliefs and Attitudes Scale 16, DBAS-16, GABA and Glx.
- Conditions
- Primary Insomnia
- Being tested
- Acupuncture
- Keywords
- Liver stagnation and spleen deficiency type 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.
AcupunctureDevice
acupuncture Baihui, Sishencong ; acupuncture bilateral Qimen, Zhangmen, Hegu, Taichong, reinforcing and reducing, until the acid swelling is obvious,stopped ferforming acupuncture, the needle was retained for 30 min.
AcupunctureDevice
（1）Acupuncture bilateral Tianrong points, obliquely 45 ± 5 ° backward, 1-1.5 inch deep, reinforcing and reducing horizontally, and stop the needle when the auricle has a heat sensation ; （2）Acupuncture at bilateral Tianyou points, pointing to the tip of the nose, with a depth of 0.5-1 inches, flat reinforcing and reducing, until the sense of soreness and distension obviously stops, and the needle is retained for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | This group will include 48 patients. Conventional acupuncture, patients take the supine position Receives: Device: Acupuncture |
| Acupuncture group | Experimental | This group will include 48 patients. The patient was placed in a supine position. Receives: Device: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality measured by Pittsburgh sleep quality index ( PSQI)
The patients will be assessed by PSQI Chinese fixed questionnaire at each observation point and the clinical efficacy will be observed.It consists of 19 self-evaluation and 5 other-evaluation items. Only 19 self-evaluation questions are scored, and 19 self-evaluation questions are composed of 7 factors, each factor consists of 7 factors of 0-3 points. '0 ' refers to no difficulty, ' 3 ' refers to very difficult. The total score of ' 21 ' refers to very difficult in all respects. The sum of all factor scores constitutes the total score of the 0-21 scale. The reference boundary value of adult sleep quality problems in China : poor sleep quality : PSQI ≥ 8 ; good sleep quality : PSQI ≤ 7 ; the higher the score, the worse the sleep quality.
Measured: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
Quality of life measure by 36-item short form health survey（SF-36）
The patients will be evaluated by SF-36 scale at each observation point. The SF-36 scale is a general scale developed by the American Medical Research Group to evaluate the quality of life. It is widely recognized and widely used in the world. This scale has eight dimensions to evaluate health-related quality of life ( HRQOL ), which belong to two categories of physical health and mental health, namely physiological function ( PF ), role physical ( RP ), bodily pain ( BP ), general health ( CH ), vitality ( VT ), social function ( SF ), role emotional ( RE ), mental health ( MH ). In addition, the SF-36 scale also includes another indicator - health change ( HT ), which is used to evaluate health changes over the past year.Add the scores of each item to the actual score, and then calculate the final score RP according to the following formula. The higher the RP score, the better the health status.
Measured: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
Secondary outcomes (4)
Insomnia Severity Index（ISI）
The patients were evaluated by ISI scale at each observation point. According to the total score, the degree of insomnia is divided into the following degrees：The total score between 0 and 7 indicates no clinically significant insomnia, the total score between 8 and 14 indicates subthreshold insomnia, the total score between 15 and 21 indicates clinical insomnia ( moderate to severe ), and the total score between 22 and 28 indicates clinical insomnia ( severe ).
Measured: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
Dysfunctional Beliefs and Attitudes about Sleep Scale 16，DBAS-16 (DBAS-16)
There were 16 items in DBAS-16, including 4 factors : an estimated factor for the consequences of insomnia ; worry about sleep factor ; expectation factors of sleep ; cognition factors of insomnia drugs.The lower the total score, the more likely it is that the subjects ' cognition of sleep is biased.
Measured: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
GABA
GABA is the most important inhibitory neurotransmitter in the central nervous system. In clinical studies, proton magnetic resonance spectroscopy showed that GABA in the brain of patients with primary insomnia was 30 % lower than that of normal people, and sleep time was prolonged with the increase of GABA content.
Measured: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
Glx
Glutamate glutamine complex ( Glx ) is glutamic acid ( Glu ) + glutamine ( Gln ). Glu is the main excitatory neurotransmitter, maintaining the excitability of organisms. In the clinical study, the content of Glu in the brain of insomnia patients was analyzed by EEG ultra-slow fluctuation technique. The results showed that the content of Glu in insomnia patients increased.
Measured: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Jan 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary 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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuanlong Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chuanlong Zhou, The Third Affiliated hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782815
- Sponsor's protocol ID
- 2024ZL531-primary insomnia
- Status last verified
- Feb 2025
- First submitted
- 16 Dec 2024
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fu S, He K, Zhou C. Curative Effect and Autonomic Nerve Function of Patients With Primary Insomnia of Liver Depression and Spleen Deficiency Type Based on the Acupoint Selection of Meridian Theory: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 22;15:e84122. doi: 10.2196/84122.
PubMed 41570299
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Curative Effect and Autonomic Nerve Function of Primary Insomnia Patients with Liver Depression and Spleen Deficiency Type Based on Acupoint Selection of Meridian Theory
- ClinicalTrials.gov ID
- NCT06782815
- Acronym / sponsor ID
- 2024ZL531-primary insomnia
- Conditions
- Primary Insomnia
- Keywords
- Liver stagnation and spleen deficiency type insomnia, Acupuncture, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Chuanlong ZhouUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jan 2025 (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 classical literature combined with modern medicine to select acupoints, in order to intervene in the autonomic nerve function of the superior cervical sympathetic ganglion as an opportunity, put forward the meridian acupoints mainly to reconcile the head orifices Ying Wei, acupuncture treatment of primary insomnia clinical research. Heart rate variability ( HRV ), Pittsburgh sleep quality index ( PSQI ), polysomnography ( PSG ) and the MOS item short from health survey ( SF-36 ) were observed. Insomnia Severity Index ( ISI ), Dysfunctional Beliefs and Attitudes about Sleep Scale 16 ( DBAS-16 ), GABA, Glx and other secondary indicators were used to clarify the clinical short-term and long-term efficacy of different acupoints in the treatment of patients with primary insomnia and the intervention effect on HRV.
Detailed description
In this randomized controlled trial, 96 patients with insomnia of liver depression and spleen deficiency type were selected from the Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine. All patients will be randomly assigned to the control group or the acupuncture group.
MAIN OUTCOME MEASURES : Pittsburgh Sleep Quality Index ( PSQI ) was used to measure sleep quality, and 36-Item Short Form Health Survey ( SF-36 ) was used to measure quality of life. Secondary outcomes included the Insomnia Severity Index ( ISI ), Sleep Dysfunction Beliefs and Attitudes Scale 16, DBAS-16, GABA and Glx.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Device: AcupunctureThis group will include 48 patients. Conventional acupuncture, patients take the supine position |
| Acupuncture group | Experimental | Device: AcupunctureThis group will include 48 patients. The patient was placed in a supine position. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- In line with the diagnostic criteria of insomnia of liver depression and spleen deficiency type in traditional Chinese medicine :
- In line with the Western diagnostic criteria for insomnia ;
- 18 ≤ age ≤ 40 years old, male or female ;
- patients with a course of more than two weeks ; Note: The above criteria must be met for inclusion in this study.
Key exclusion criteria (4 listed)
- Insomnia caused by a variety of organic diseases, neurological or psychiatric disorders
- Pregnancy, lactation or drug allergy
- There are more serious primary diseases such as cardiovascular and cerebrovascular diseases, gastrointestinal diseases, endocrine system diseases, or psychiatric patients.
- Patients with coagulation dysfunction and bleeding tendency.
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 |
|---|---|---|
| Acupunctureacupuncture Baihui, Sishencong ; acupuncture bilateral Qimen, Zhangmen, Hegu, Taichong, reinforcing and reducing, until the acid swelling is obvious,stopped ferforming acupuncture, the needle was retained for 30 min. | Device | Control group |
| Acupuncture（1）Acupuncture bilateral Tianrong points, obliquely 45 ± 5 ° backward, 1-1.5 inch deep, reinforcing and reducing horizontally, and stop the needle when the auricle has a heat sensation ; （2）Acupuncture at bilateral Tianyou points, pointing to the tip of the nose, with a depth of 0.5-1 inches, flat reinforcing and reducing, until the sense of soreness and distension obviously stops, and the needle is retained for 30 minutes. | Device | Acupuncture group |
Primary outcome
Sleep quality measured by Pittsburgh sleep quality index ( PSQI)
Time frame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
The patients will be assessed by PSQI Chinese fixed questionnaire at each observation point and the clinical efficacy will be observed.It consists of 19 self-evaluation and 5 other-evaluation items. Only 19 self-evaluation questions are scored, and 19 self-evaluation questions are composed of 7 factors, each factor consists of 7 factors of 0-3 points. '0 ' refers to no difficulty, ' 3 ' refers to very difficult. The total score of ' 21 ' refers to very difficult in all respects. The sum of all factor scores constitutes the total score of the 0-21 scale. The reference boundary value of adult sleep quality problems in China : poor sleep quality : PSQI ≥ 8 ; good sleep quality : PSQI ≤ 7 ; the higher the score, the worse the sleep quality.
Quality of life measure by 36-item short form health survey（SF-36）
Time frame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
The patients will be evaluated by SF-36 scale at each observation point. The SF-36 scale is a general scale developed by the American Medical Research Group to evaluate the quality of life. It is widely recognized and widely used in the world. This scale has eight dimensions to evaluate health-related quality of life ( HRQOL ), which belong to two categories of physical health and mental health, namely physiological function ( PF ), role physical ( RP ), bodily pain ( BP ), general health ( CH ), vitality ( VT ), social function ( SF ), role emotional ( RE ), mental health ( MH ). In addition, the SF-36 scale also includes another indicator - health change ( HT ), which is used to evaluate health changes over the past year.Add the scores of each item to the actual score, and then calculate the final score RP according to the following formula. The higher the RP score, the better the health status.
4 secondary outcomes
Insomnia Severity Index（ISI）
Time frame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
Dysfunctional Beliefs and Attitudes about Sleep Scale 16，DBAS-16 (DBAS-16)
Time frame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
GABA
Time frame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
Glx
Time frame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Derived from this study: PubMed 41570299Fu S, He K, Zhou C. Curative Effect and Autonomic Nerve Function of Patients With Primary Insomnia of Liver Depression and Spleen Deficiency Type Based on the Acupoint Selection of Meridian Theory: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Jan 22;15:e84122. doi: 10.2196/84122.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Primary Insomnia, run by Chuanlong Zhou 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhou CL Zhou Chuanlong (15868486255, 471388079@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality measured by Pittsburgh sleep quality index ( PSQI) (time frame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.). The study lists 2 primary outcomes in all. 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 NCT06782815, which also lists 1 linked publication.
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 11 Feb 2025.