Skip to content

Clinical Study on the Effect of "Xingnao Kaiqiao" Acupuncture on Regulating Cerebral Cortex Excitability to Improve Insomnia in Sub-healthy Patients

Clinical Study on the Effect of "Xingnao Kaiqiao" Acupuncture on Regulating Cerebral Cortex Excitability to Improve Insomnia in Sub-healthy Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000774
Enrollment
Unknown
Registered
2025-04-17
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Insomnia

Interventions

Medication control group:Oral benzodiazepine medications
Control group:Conventional acupuncture
Experimental group: "Xingnao Kaiqiao" Acupuncture

Sponsors

Chengdu Integrated TCM&Western Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Participants must meet the diagnostic criteria for both sub-health status and insomnia with the condition persisting for more than 3 months. (1) The diagnostic criteria for sub-health status are based on the 2006 *Clinical Guidelines for Sub-health in Traditional Chinese Medicine*: 1) Predominant physical symptoms such as fatigue sleep disturbances or pain; 2) Predominant psychological symptoms such as depression anxiety irritability fear short-term memory decline or difficulty concentrating; 3) Predominant decline in social adaptability such as reduced frequency of social interactions or strained interpersonal relationships. Any one of the above three conditions lasting for more than 3 months with systemic examinations ruling out other diseases that may cause these manifestations. (2) The diagnostic criteria for insomnia are based on the *People's Medical Publishing House·Neurology·Second Edition*: 1) Complaints of insomnia including difficulty falling asleep (taking more than 30 minutes to fall asleep) frequent awakenings (more than twice per night) vivid dreams early morning awakenings or difficulty falling back asleep after waking up (taking more than 30 minutes to fall back asleep); 2) Impaired social functioning with daytime symptoms such as dizziness fatigue sleepiness difficulty concentrating and reduced work performance; 3) The above symptoms occur more than 3 times per week and persist for at least 1 month. 2.2 Athens Insomnia Scale score > 7; 2.3 Age between 18 and 65 years; no gender restrictions; approved by the medical ethics committee and voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) Pregnant or lactating women or individuals unable to express their own sensations; (2) Those with severe cardiac hepatic or renal dysfunction or severe heart disease; (3) Individuals who have received any relevant treatment within the past 2 weeks; (4) Those with a history of drug or alcohol abuse or a history of mental illness; (5) Individuals with metal implants in the skull or those with implanted devices such as pulse generators cardiac pacemakers implantable drug pumps implantable defibrillators or implantable neurostimulators as well as those with cochlear implants; (6) Individuals with skull defects increased intracranial pressure hearing impairment or a personal or family history of epilepsy; (7) Those who refuse to participate withdraw midway from the study or fail to sign the informed consent

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality IndexPSQI;

Secondary

MeasureTime frame
sleep efficiency;Self-Rating Depression Scale;Standard for Improvement of TCM Syndromes;Cerebral Cortex Excitability;Self-Rating Anxiety Scale;

Countries

China

Contacts

Public ContactHou Tianshu

Chengdu Integrated TCM&Western Medicine Hospital

houtianshu@cdutcm.edu.cn+86 138 8068 5086

Outcome results

None listed

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