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Randomized Controlled Trial and Cerebral Hemodynamics Study of Acupuncture Treatment for Primary Insomnia

Randomized Controlled Trial and Cerebral Hemodynamics Study of Acupuncture Treatment for Primary Insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000807
Enrollment
Unknown
Registered
2026-03-30
Start date
2026-04-09
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Primary insomnia

Interventions

Experimental Group:Acupuncture
Control Group:sham acupuncture

Sponsors

Deyang Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Those who meet the diagnostic criteria for primary insomnia in Western medicine and the diagnostic criteria for insomnia in traditional Chinese medicine; (2) 18 = age = 60 years old, both males and females; (3) No communication barriers; (4) Signed informed consent. Note: Participants must meet all four criteria to be included in this study.

Exclusion criteria

Exclusion criteria: (1) Those who do not meet the diagnostic criteria; (2) Secondary insomnia caused by other somatic diseases; or long-term sleep disturbance due to environmental or other human factors; or those who cannot be excluded from having other types of sleep disorders; (3) Patients with progressive malignant tumors or other severe wasting diseases, prone to infections and bleeding; or those with severe primary diseases of the cardiovascular, liver, kidney, digestive, or hematopoietic systems; (4) Individuals with impaired consciousness who cannot express subjective symptoms of discomfort, or patients with mental illness; (5) Participants who received acupuncture treatment for insomnia within one month prior to enrollment; (6) Breastfeeding or pregnant women, or individuals prone to fainting during acupuncture. Note: Any participant who meets any of the above criteria should be excluded.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI);

Secondary

MeasureTime frame
Insomnia Severity Index;Hamilton Anxiety Rating Scale;Hamilton Depression Rating Scale;"Fatigue Severity Scale";Cerebral hemodynamic indices;

Countries

China

Contacts

Public ContactJin Song

Deyang Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

1049147000@qq.com18980880353

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026