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Study on the clinical efficacy and mechanisms of acupoint hypersensitivity in the treatment of primary insomnia with acupuncture intervention.

Study on the clinical efficacy and mechanisms of acupoint hypersensitivity in the treatment of primary insomnia with acupuncture intervention.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002532
Enrollment
Unknown
Registered
2025-12-24
Start date
2025-11-17
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Primary insomnia

Interventions

Sensitized Acupoint Acupuncture Group:(1) Acupoints: Juque, Xinyu Shuang, Fengchi Shuang, Taiyang Shuang. (2) Positioning: Refer to the 2021 National Standard of the People's Republic of China (GB/T 1
Sham acupuncture group:(1) Acupoint take: 4 non-meridian and non-acupuncture points are selected (2) Positioning: Referring to [50], the false needle point is set 2 cm next to the real needle point, b

Sponsors

Zhejiang University of Traditional Chinese Medicine Affiliated Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for primary insomnia disorder; (2) Age between 18 and 80 years, gender; (3) No communication or cognitive impairments; (4) No use or discontinuation of anti-anxiety or other psychotropic medications within the past month; (5) No major somatic diseases; (6) Voluntarily accepts the study content and is able to complete all assessments and polysomnography; (7) Signed the informed consent form before the start of the study; (8) Patients with mild to moderate insomnia, as indicated by a Pittsburgh sleep quality index score of 7-16.

Exclusion criteria

Exclusion criteria: (1) Those with severe mental disorders, a history of severe head trauma, and accompanied by significant consciousness disorders; (2) Those with severe liver or kidney dysfunction and a tendency to bleed; (3) Those who are heavy drinkers (=100ml of white liquor per day), smokers (=15 cigarettes per day), drug users, or currently taking psychotropic medications; (4) Those with other sleep disorders, such as sleep apnea-hypopnea syndrome, narcolepsy, or REM sleep behavior disorder; (5) Those who are pregnant or breastfeeding; (6) Those with other serious illnesses that are poorly controlled; (7) Those with skin damage at the acupuncture points; (8) Those who are unwilling to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Self-Rating Anxiety Scale;Self-Rating Depression Scale;mechanical pain threshold;Polysomnography;Heart Rate Variability;

Countries

China

Contacts

Public ContactLiu Yingjun

Zhejiang University of Traditional Chinese Medicine Affiliated Third Hospital

frankly120@163.com15958033054

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026