Clinical Observation of Facial Acupuncture for Insomnia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia
• Intervention / Treatment: Procedure: facial acupuncture; Procedure: facial scraping

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yixin Zhang; Phone Number: 86+15365250510; Email: 652385287@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Facial acupuncture treatment group	Procedure: facial acupuncture; Acupuncture at specific points, each time leaving the needle for 30 minutes, twice a week, for four weeks.
Active Comparator: Facial scraping treatment group	Procedure: facial scraping; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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%.	Week 4

Collaborators and Investigators

• Sponsor: Pei Yuan

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2026
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): June 20, 2026

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 202510268122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No