InsomniaNCT07381647
Clinical Observation of Facial Acupuncture for Insomnia
A study testing facial acupuncture and facial scraping in people with Insomnia, run by Pei Yuan.
Trial summary
Insomnia is one of the most common mental disorders and has shown an upward trend in recent years. The commonly used western medicine treatment methods are easy produce drug-related adverse reactions, and there are problems such as the decline of efficacy and the production of drug dependence after long-term… Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Insomnia
- What is being tested?
- facial acupuncture and facial scraping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2026to 20 Jun 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 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meets the diagnostic criteria for insomnia in both Western and traditional Chinese medicine and the classification criteria for TCM syndrome differentiation;
- Between 16 and 30 years old (including 16 and 30 years old);
- No mental or language disorders;
- PQSI score ≥ 7;
- No hypnotic medication treatment within two weeks before the study;
- Patient informed consent, and voluntarily participate in this.
Who cannot join
- Those who do not meet the above inclusion criteria;
- Those with secondary insomnia caused by organic diseases, mental diseases etc.;
- Those who faint at acupuncture or refuse acupuncture;
- Those who have received any facial acupuncture or thread embedding within 3 months;
- Those who have received radiofrequency or laser wrinkle removal treatment within half a year;
- Those who have received facial tissue filler injection and A-type botulinum toxin injection and other long-term facial rejuvenation treatment within one year;
Show all 10Show fewer
- Pregnant or lactating, those preparing for pregnancy during the treatment process;
- Those who work night shifts for a long time, with irregular work and rest;
- Those withocrine function, immune function diseases, and those with severe primary diseases of the heart, brain, liver, kidney and hematopoietic system;
- Those who cannot cooperate with the treatment. Note: Those who meet any of the above items are not included in this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Observation of Facial Acupuncture for Insomnia Based on Zangfu Meridian Theory
Insomnia is one of the most common mental disorders and has shown an upward trend in recent years. The commonly used western medicine treatment methods are easy produce drug-related adverse reactions, and there are problems such as the decline of efficacy and the production of drug dependence after long-term medication. Traditional Chinese medicine treatment of insomnia on syndrome differentiation. In this study, taking the common heart and spleen deficiency syndrome and liver depression transforming into fire syndrome as examples, based on the theory of zangfu andingluo, we explored the selection of acupoints for acupuncture treatment of insomnia and conducted clinical efficacy observation. Combined with the analysis of the changes of Pittsburgh Quality Index, Hamilton Anxiety Scale, Traditional Chinese Medicine Syndrome Efficacy Rating, Infrared Thermal Image Acquisition, Forehead Adhesive Sleep Recorder and other data, the acupuncture treatment of insomnia patients was expounded.
- Conditions
- Insomnia
- Being tested
- facial acupuncture, facial scraping
- 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.
facial acupunctureProcedure or surgery
Acupuncture at specific points, each time leaving the needle for 30 minutes, twice a week, for four weeks.
facial scrapingProcedure or surgery
Scrape the specific areas of the face, each time for 15-20 minutes, twice a week, with an interval of at least 2, for 4 weeks continuously, a total of 8 times.
| Study group | Role | What they receive |
|---|---|---|
| Facial acupuncture treatment group | Experimental | Not described Receives: Procedure: facial acupuncture |
| Facial scraping treatment group | Active comparator | Not described Receives: Procedure: facial scraping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
There are 19 sleep-related self-assessment questions that make up 7 components ranging from 0 to 3 points. The total score evaluation is: 0 to 5. Good sleep quality. 6 to 10. The sleep quality is okay. 11-15 Sleep quality is average; The sleep quality from 16 to 21 was very poor.
The PSQI score reduction rate = (pre-treatment score - post-treatment score)/pre-treatment score ×100%. Cure: PSQI score reduction rate ≥75%. Effective rate: 50%≤ deduction rate < 75%. Effective: 25%≤ deduction rate < 50%. Invalid: PSQI deduction rate < 25%. The total effective rate = (number of cured patients + number of markedly effective patients + number of effective patients)/Total number of patients in this group of trials ×100%
Measured: Week 4
Secondary outcomes (3)
Traditional Chinese Medicine Syndrome Efficacy Assessment
According to the "Diagnostic and Therapeutic Criteria for Symptoms of Traditional Chinese Medicine", 11 observation indicators for insomnia of the heart andleen deficiency type were formulated. The TCM syndrome scoring table consists of 11 symptoms including sleep, dreaminess, palpitation, asthenia, dizziness,orexia, abdominal distension, loose stool, complexion, tongue image, and pulse condition. The first four items are scored according to 0, 2, 4 and 6 points, and the remaining seven items are scored according to 0-3 points, with a full score of 45 points. The higher the score, the consistent the symptoms are with the heart and spleen deficiency type.
Measured: Week 4
Hamilton Anxiety Scale
The table includes 14 items, all of which adopt a 5-point scoring method of 0-4 points, 0 points: asymptomatic 1 point: mild; 2 points: moderate; 3 points: severe; 4 points: extremely severe.
Measured: Week 4
Infrared thermal image acquisition
Compare the average temperature (℃) of the forehead and abdomen before and after treatment. A decrease in temperature after treatment indicates effectiveness. Through infrared thermal imaging, the sleep line on the forehead: ａ．Significantly effective: the sleep line completely disappears; ｂ．Effective: the sleep line changes from bilateral to unilateral;Ｃ．Ineffective: the sleep line does not change significantly. The total effective rate of sleep line improvement = (number of significantly effective cases number of effective cases) / number of cases × 100.0%.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start20 Jan 2026 (estimated)
- Primary completion20 May 2026 (estimated)
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pei Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pei Yuan, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381647
- Sponsor's protocol ID
- 202510268122
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of Facial Acupuncture for Insomnia Based on Zangfu Meridian Theory
- ClinicalTrials.gov ID
- NCT07381647
- Acronym / sponsor ID
- 202510268122
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Pei YuanUniversity, hospital or other
- Study start
- 20 Jan 2026 (estimated)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 2 Feb 2026 (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.
Insomnia is one of the most common mental disorders and has shown an upward trend in recent years. The commonly used western medicine treatment methods are easy produce drug-related adverse reactions, and there are problems such as the decline of efficacy and the production of drug dependence after long-term medication. Traditional Chinese medicine treatment of insomnia on syndrome differentiation. In this study, taking the common heart and spleen deficiency syndrome and liver depression transforming into fire syndrome as examples, based on the theory of zangfu andingluo, we explored the selection of acupoints for acupuncture treatment of insomnia and conducted clinical efficacy observation. Combined with the analysis of the changes of Pittsburgh Quality Index, Hamilton Anxiety Scale, Traditional Chinese Medicine Syndrome Efficacy Rating, Infrared Thermal Image Acquisition, Forehead Adhesive Sleep Recorder and other data, the acupuncture treatment of insomnia patients was expounded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facial acupuncture treatment group | Experimental | Procedure: facial acupuncture |
| Facial scraping treatment group | Active comparator | Procedure: facial scraping |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Meets the diagnostic criteria for insomnia in both Western and traditional Chinese medicine and the classification criteria for TCM syndrome differentiation;
- Between 16 and 30 years old (including 16 and 30 years old);
- No mental or language disorders;
- PQSI score ≥ 7;
- No hypnotic medication treatment within two weeks before the study;
Key exclusion criteria (10 listed)
- Those who do not meet the above inclusion criteria;
- Those with secondary insomnia caused by organic diseases, mental diseases etc.;
- Those who faint at acupuncture or refuse acupuncture;
- Those who have received any facial acupuncture or thread embedding within 3 months;
- Those who have received radiofrequency or laser wrinkle removal treatment within half a year;
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 |
|---|---|---|
| facial acupunctureAcupuncture at specific points, each time leaving the needle for 30 minutes, twice a week, for four weeks. | Procedure or surgery | Facial acupuncture treatment group |
| facial scrapingScrape the specific areas of the face, each time for 15-20 minutes, twice a week, with an interval of at least 2, for 4 weeks continuously, a total of 8 times. | Procedure or surgery | Facial scraping treatment group |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: Week 4
There are 19 sleep-related self-assessment questions that make up 7 components ranging from 0 to 3 points. The total score evaluation is: 0 to 5. Good sleep quality. 6 to 10. The sleep quality is okay. 11-15 Sleep quality is average; The sleep quality from 16 to 21 was very poor. The PSQI score reduction rate = (pre-treatment score - post-treatment score)/pre-treatment score ×100%. Cure: PSQI score reduction rate ≥75%. Effective rate: 50%≤ deduction rate < 75%. Effective: 25%≤ deduction rate < 50%. Invalid: PSQI deduction rate < 25%. The total effective rate = (number of cured patients + number of markedly effective patients + number of effective patients)/Total number of patients in this group of trials ×100%
3 secondary outcomes
Traditional Chinese Medicine Syndrome Efficacy Assessment
Time frame: Week 4
Hamilton Anxiety Scale
Time frame: Week 4
Infrared thermal image acquisition
Time frame: Week 4
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 2 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
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.
Questions about this trial
What is this clinical trial studying?
A study testing facial acupuncture and facial scraping in people with Insomnia, run by Pei Yuan.
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 10 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: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Yixin Zhang (86+15365250510, 652385287@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 (time frame: Week 4). 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 2 Feb 2026.