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Observation on the clinical effect of needling EX-HN1 encircling DU20 in the treatment of small cerebral vascular disease complicated with insomnia

Observation on the clinical effect of needling EX-HN1 encircling DU20 in the treatment of small cerebral vascular disease complicated with insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000211
Enrollment
Unknown
Registered
2025-02-06
Start date
2025-02-15
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

small cerebral vascular disease complicated with insomnia

Interventions

Control group:Cognitive Behavioral Therapy for Insomnia
experimental group:Acupuncture and Cognitive Behavioral Therapy for Insomnia

Sponsors

the People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. It also fulfilled the diagnostic criteria for cognitive dysfunction and insomnia in small cerebral vascular disease. 2. Male and female patients aged 45 to 75. 3. Years of education above 8 years or at the junior high school education level and above. 4. PSQI score ranging from 7 to 15 points MoCA score ranging from 19 to 25 points. 5. The patient voluntarily participated in this study and had not received treatment related to other subjects within nearly 1 month. 6. The informed consent was signed by the patient himself or by his immediate family members.

Exclusion criteria

Exclusion criteria: Presence of other imaging changes or diseases sufficient to explain memory or other cognitive impairments including: non-cavitary infarctions in both cortical and subcortical regions cerebral hemorrhage; specific causes of white matter changes (e.g. multiple sclerosis tuberous sclerosis brain radiotherapy); brain lesions (such as Alzheimer's disease Lewy body dementia frontotemporal dementia Parkinson's disease tumors hydrocephalus trauma syphilis acquired immunodeficiency syndrome Creutzfeldt-Jakob disease etc.); severe psychiatric disorders and epilepsy substance abuse (including alcohol) poisoning and metabolic abnormalities; significant anxiety depression affective disorders schizophrenia and other severe mental disorders; current or recent (within the past week) use of benzodiazepine receptor agonists (BzRAs) or melatonin receptor agonists (such as ramelteon) and sedative antidepressants (such as trazodone mirtazapine fluvoxamine and dosulepin); dependency on the aforementioned medications requiring a daily dosage exceeding two tablets with difficulty in discontinuation; primary insomnia patients with a duration of more than ten years; individuals with a fear of needles or coagulation disorders that prevent them from undergoing acupuncture treatment; women who are currently breastfeeding or pregnant or those with recent intentions to conceive.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index Scale;

Secondary

MeasureTime frame
Montreal Cognitive Assessment Scale;Serum irisin;

Countries

China

Contacts

Public ContactChen Yifan

The Peoples Hospital Affiliated of Fujian University of Traditional Chinese Medicine

1140768262@qq.com13645021563

Outcome results

None listed

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