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A multicenter randomized parallel controlled clinical study on the efficacy and safety of acupuncture in the treatment of post-stroke insomnia

A multicenter randomized parallel controlled clinical study on the efficacy and safety of acupuncture in the treatment of post-stroke insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001188
Enrollment
Unknown
Registered
2025-06-16
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

post-stroke insomnia

Interventions

Control group:Standard treatment for cerebrovascular diseases + sleep hygiene guidance + basic acupuncture treatment to invigorate the brain and open the orifices + pseudo-acupuncture operation at the
Experimental group:Standard treatment for cerebrovascular diseases + sleep hygiene guidance + basic acupuncture treatment to invigorate the brain and open the orifices + acupuncture operation at the F

Sponsors

The First Hospital of Jilin University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) For those who meet the diagnostic criteria for ischemic stroke and insomnia if insomnia first occurs after cerebral infarction or if insomnia existed before the onset but persists or worsens after cerebral infarction it can be included in the treatment. (2) The course of ischemic stroke is less than 90 days; (3) Age: 18 to 75 years old; (4) Baseline screening was conducted for patients with moderate to severe insomnia with an ISI grade of =15 points; (5) Clear consciousness and willing to cooperate with acupuncture treatment; (6) No sedative-hypnotic drugs have been taken in the past week; (7) Voluntarily participate and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those with severe organ diseases or infectious diseases; (2) Those with severe mental disorders such as schizophrenia; (3) Those with a history of severe insomnia and other sleep disorders (such as respiratory-related sleep disorders); (4) Those with unstable vital signs severe cognitive impairment aphasia hearing and consciousness disorders that are difficult to cooperate with acupuncture treatment; (5) Those who are intolerant to acupuncture; (6) Those who have been drinking alcohol excessively for a long time consuming strong tea coffee or abusing or relying on psychotropic drugs; (7) Those who are assessed by the researcher as unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
The difference in Pittsburgh Sleep Quality Index(PSQI) scores;

Secondary

MeasureTime frame
The differences in the Pittsburgh Sleep Quality Index (baseline, 2 weeks of treatment, follow-up period), Insomnia Severity Index Scale, Self-Rating Sleep Status Scale, Generalized Anxiety Scale, Hamilton Depression Scale, Modified Rankin Scale, Neurological Deficit Score, and Stroke Specialized Quality of Life Scale score (baseline, 2 weeks of treatment, 4 weeks of treatment, follow-up period);

Countries

China

Contacts

Public Contactjiawei-HAN

The First Hospital of Jilin University

cherhan1221@163.com13844192920

Outcome results

None listed

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