Clinical Observation of Facial Acupuncture for Insomnia

NCT07381647 | Not Yet Recruiting

• 1 other identifier: 202510268122
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Traditional Chinese Medicine Syndrome Efficacy Assessment

  Week 4

• Hamilton Anxiety Scale

  Week 4

• Infrared thermal image acquisition

  Week 4

Study Arms (2)

Facial acupuncture treatment group

EXPERIMENTAL

Procedure: facial acupuncture

Facial scraping treatment group

ACTIVE COMPARATOR

Procedure: facial scraping

Interventions

facial scraping PROCEDURE

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.

Facial scraping treatment group

facial acupuncture PROCEDURE

Acupuncture at specific points, each time leaving the needle for 30 minutes, twice a week, for four weeks.

Facial acupuncture treatment group

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pei Yuan: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Yixin Zhang

CONTACT

86+15365250510; 652385287@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: February 2, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share