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A fNIRS-Based Study on the Clinical Efficacy and Mechanisms of Musculoskeletal Ultrasound-Guided Acupuncture in Treating Chronic Insomnia

A Clinical Study on Musculoskeletal Ultrasound-Guided Acupuncture Therapy for Refractory Insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000535
Enrollment
Unknown
Registered
2025-03-17
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

intractable insomnia

Interventions

observer group:Ultrasound-guided acupuncture of stellate ganglion combined with conventional acupuncture
control group:conventional acupuncture

Sponsors

Tongde Hospital of Zhejiang Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria for Chronic Insomnia Patients 1) Meet ICSD-3 diagnostic criteria for chronic insomnia disorder with an Insomnia Severity Index (ISI) score =10; 2) No gender restriction; aged 18–70 years; right-handed; 3) No use of medications or therapeutic interventions for insomnia within 1 month prior to enrollment; 4) Capable of normal communication and able to actively cooperate with treatment; 5) Willing to participate in the study and sign an informed consent form. Inclusion Criteria for Healthy Participants 1) No gender restriction; aged 18–70 years; right-handed; 2) Physically and mentally healthy with a well-proportioned body build coordinated movements sufficient energy and optimistic attitude toward daily activities; 3) Good sleep quality with adequate rest; 4) No history of cardiovascular hepatic renal or other major organ diseases or chronic illnesses; 5) Voluntarily agree to participate in the trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1) Failure to meet the diagnostic criteria for chronic insomnia or any of the inclusion criteria listed above; 2) Pregnant or lactating individuals; 3) Patients with life-threatening conditions such as cardiovascular/cerebrovascular diseases cancer nephritis hematologic disorders psychiatric disorders or infectious diseases; 4) Patients with severe depression (Hamilton Depression Rating Scale [HAMD-17] score >24); 5) Individuals with a history of abuse or severe dependence on antidepressants central nervous system stimulants or psychoactive substances (e.g. alcohol); 6) Secondary insomnia caused by other organic diseases; 7) History of needle fainting or skin lesions at acunpuncture sites; 8) Metal allergy. 9)Those who are participating in other research projects.

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index;fNIRS date;

Secondary

MeasureTime frame
comprehensive evaluation of therapeutic effect;Hamilton Anxiety Rating Scale;Pittsburgh Sleep Quality Index PSQI;

Countries

China

Contacts

Public ContactHao Liu

Tongde Hospital of Zhejiang Province

Haoliu1987@aliyun.com15868814927

Outcome results

None listed

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