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Research on the Mechanism of "Big Trifocal Theory" Based on Cheek Needling in Treating Chronic Insomnia by Regulating Serum Brain-Gut Peptide Levels to Improve Sleep Quality

Research on the Mechanism of "Big Trifocal Theory" Based on Cheek Needling in Treating Chronic Insomnia by Regulating Serum Brain-Gut Peptide Levels to Improve Sleep Quality

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124433
Enrollment
Unknown
Registered
2026-05-12
Start date
2026-04-02
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic insomnia

Interventions

Cheek needle group:The cheek needle and tricuspid needle technique is performed twice a week for a total of 4 weeks.
The Western medicine group:Estazolam is taken orally, one tablet per night, for a total of 4 weeks.

Sponsors

Changzhou Third People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 20 - 60 years old, gender not restricted; 2. Meets the diagnostic criteria for chronic insomnia as defined in the 3rd edition of the International Classification of Sleep Disorders (ICSD-3) (duration >= 3 months, with at least 3 nights per week experiencing difficulty falling asleep / maintaining sleep / early awakening, accompanied by daytime functional impairment); 3. Signed the informed consent form, voluntarily participated in this study, and was able to cooperate with the treatment and all evaluations.

Exclusion criteria

Exclusion criteria: 1. Those with severe mental disorders (such as schizophrenia, severe depression/anxiety disorders, etc.), and severe chronic physical diseases of the heart, liver, kidneys, etc.; 2. Those allergic to cheek acupuncture needles or estazolam drugs; 3. Those who have used other sedative-hypnotic drugs within the last 1 month or participated in other clinical studies; 4. Pregnant or lactating women; 5. Those with cognitive dysfunction and unable to cooperate in completing the scale assessment and the research process.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index Score;Insomnia Severity Index Score;

Secondary

MeasureTime frame
Neuropeptide Y;P substance;5-hydroxytryptamine 1A receptor;5-hydroxytryptamine 2A receptor;

Countries

China

Contacts

Public ContactHan Hongyue

Changzhou Third People's Hospital

492915722@qq.com+86 180 2053 2585

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026