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Effects of Remote Ischemic Postconditioning on Sleep Function in Stroke Patients with Sleep Dysfunction during Rehabilitation: A Pilot Randomized Controlled Trial

Effects of Remote Ischemic Postconditioning on Sleep Function in Stroke Patients with Sleep Dysfunction during Rehabilitation: A Pilot Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128371
Enrollment
Unknown
Registered
2026-07-19
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

Stroke combined with sleep disorders

Interventions

Control group:Conventional rehabilitation treatment + post-treatment after distant ischemia adaptation (sham treatment) (intervention was carried out with post-treatment after distant ischemia: the cu
Intervention Group:Conventional rehabilitation treatment + post-adaptation treatment for distant ischemia (intervention with post-treatment for distant ischemia: compression of bilateral brachial arte

Sponsors

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age for enrollment: 18-85 years old; 2. Rehabilitation inpatients confirmed as having suffered a stroke by CT or MRI; More than one week after being diagnosed with stroke; 3. The sleep disorder was clearly identified by applying the Sleep Disorder Rating Scale (Pittsburgh Sleep Score >7); 4. Stable condition: Vital signs are stable, and there are no serious complications (such as severe infection, malignant hypertension, acute myocardial infarction, etc.); 5. Cognitive and communication skills: Capable of cooperating to complete the assessment and treatment (MMSE>=18 points); 6. Informed consent and voluntary participation; 7. No relevant intervention received: No distant ischemic adaptation therapy or other similar ischemic adaptation therapy has been received.

Exclusion criteria

Exclusion criteria: 1. Patients with unstable conditions who have developed secondary cerebrovascular stroke or new cerebral infarction. 2. Patients with contraindications to remote ischemic conditioning therapy, such as severe soft tissue injury, fracture, or vascular injury of the upper limbs; acute or subacute venous thrombosis, arterial occlusive disease, or subclavian steal syndrome in the compressed limb. 3. Cardioembolic etiology (e.g., atrial fibrillation) because of the high risk of intracranial hemorrhagic transformation. 4. Uncontrolled severe hypertension (systolic blood pressure >=180 mmHg or diastolic blood pressure >=110 mmHg after medical treatment). 5. Patients with severe cardiopulmonary problems, such as heart failure, asthma, or respiratory failure; acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within the past 6 months; clinically significant uncontrolled arrhythmias (e.g., rapid atrial fibrillation, sustained ventricular tachycardia); congestive heart failure of New York Heart Association class III or IV; symptomatic hypotension; known peripheral vascular diseases, such as upper extremity arterial occlusive disease, aortic dissection, or abdominal aortic aneurysm. 6. Hepatic insufficiency: clinically diagnosed liver cirrhosis, severe fatty liver, decompensated liver function, or active viral hepatitis (e.g., hepatitis B or C) requiring antiviral therapy. 7. Renal insufficiency: patients undergoing regular dialysis therapy. 8. Pulmonary insufficiency: clinically diagnosed severe chronic obstructive pulmonary disease or severe bronchial asthma; daily activities significantly limited, or requiring long-term home oxygen therapy. 9. Severe diabetic complications: diabetic nephropathy, diabetic retinopathy, diabetic peripheral neuropathy, or diabetic foot with a history of foot ulcer or amputation. 10. Currently participating in other clinical studies, or having participated in other clinical studies within 3 months before enrollment, or having already participated in this study.

Design outcomes

Primary

MeasureTime frame
Sleep indicators;

Secondary

MeasureTime frame
Psychological indicators;Functional indicators;Sleep monitoring device parameters;Neurological function indicators;safety endpoints;

Countries

China

Contacts

Public ContactChen Zhen

Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine

chenzhen236051@renji.com+86 21 68383215

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026