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Randomized controlled clinical trial protocol for the efficacy and safety of acupuncture in the treatment of sleep disorders after ischemic stroke

Randomized controlled clinical trial protocol for the efficacy and safety of acupuncture in the treatment of sleep disorders after ischemic stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056825
Enrollment
Unknown
Registered
2022-02-18
Start date
2022-04-01
Completion date
Unknown
Last updated
2023-09-11

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

Conditions

Sleep disorder after ischemic stroke

Interventions

Group 2:Eszopiclone
Group 3:Park sham device

Sponsors

The Third Affiliated Hospital of He'nan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years; 2. Meet the above diagnostic criteria of traditional Chinese and western medicine; 3. The course of stroke is in the recovery period (within 1 month to 3 months after onset), and has passed the critical period; 4. Pittsburgh sleep quality index (PSQI) score > 7; 5. Have not taken sedative and hypnotic drugs in the past 1 month.

Exclusion criteria

Exclusion criteria: 1. Previous cerebral hemorrhage or ischemia; 2. History of craniocerebral surgery; 3. Insomnia symptoms existed before the onset of ischemic stroke; 4. Patients with sleep apnea hypopnea syndrome; 5. Patients with coagulopathy or severe heart, liver, and kidney diseases; 6. Allergic constitution, especially those allergic to needle moxibustion; 7. Mental disorders, language communication disorders; 8. Lactating and pregnant patients.

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality index;National institute of health stroke scale;

Secondary

MeasureTime frame
Polysomnography;

Countries

China

Contacts

Public ContactChen Xinwang

The Third Affiliated Hospital of He'nan University of Chinese Medicine

361372072@qq.com+86 13526652895

Outcome results

None listed

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