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A multimodel MRI study of central mechanism in acupuncture for insomnia

A multimodel MRI study of central mechanism in acupuncture for insomnia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002516
Enrollment
Unknown
Registered
2019-08-10
Start date
2019-08-12
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

insomnia

Interventions

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Compliance with the diagnostic criteria for chronic insomnia in ICSD-3; 3. PSQI > 5 points; 4. Right-handed; 5. Did not take any drugs or substances that act on the nervous system for nearly one month, including hypnotics, psychotropics, coffee, alcohol or tea, and are not taken during the study period; 6. Voluntary 2 fMRI scans and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe heart, liver and kidney function damage, as well as blood and respiratory diseases and diagnosed as mentally ill according to the Diagnostic and Statistical Manual of Mental Disorders - 5th Edition; 2. Semi-structured clinical interviews to determine that the patient is in other sleep disorders rather than primary insomnia; 3. Patients with infectious diseases such as liver disease, tuberculosis and AIDS; 4. Those with severe digestive diseases and severe malnutrition; 5. Those who have physical illnesses, such as hypertension, diabetes, and coronary heart disease; 6. Patients with brain organic diseases; 7. Pregnant or lactating women; 8. Patients with severe trauma and unhealed or other patients who are not suitable for acupuncture, such as: allergies.

Design outcomes

Primary

MeasureTime frame
Acupuncture immediately BOLD signal;Insomnia Severity Index;BOLD signal;Pittsburgh sleep quality index;Magnetic resonance spectroscopy metabolite;

Secondary

MeasureTime frame
Epworth Sleeping Scale;Beck Depression Inventory;Beck Anxiety Inventory;Fatigue Severity Scale;

Countries

China

Contacts

Public ContactYunfei Chen

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

icyf1968@163.com+86 18930568221

Outcome results

None listed

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