Can breathing pure oxygen boost stroke recovery?
NCT ID NCT05965687
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This trial investigates whether breathing high-dose oxygen (normobaric hyperoxia) for four hours, given together with standard clot-busting medication, can improve recovery in people having an acute ischemic stroke. The study enrolls adults who arrive at the hospital within 4.5 hours of symptom onset with moderate to severe stroke symptoms. Participants are randomly assigned to receive either high-dose oxygen or standard nasal oxygen alongside their clot-busting treatment, and researchers track functional outcomes and brain damage over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- normobaric hyperoxia (high-dose oxygen given through a sealed mask for 4 hours)
- What this could lead to
- If it works, this could offer a simple, widely available way to boost the effectiveness of standard clot-busting treatment for stroke.
- What could go wrong
- This is a large phase 3 trial, but high-dose oxygen can sometimes cause lung irritation or other side effects. It is not yet known whether the added oxygen improves outcomes enough to justify routine use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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1,230 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Feb 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age≥18 years; 2. The time from onset to randomization is within 4.5 hours of onset; 3. The clinical diagnosis is acute ischemic stroke (the criteria followed the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018); 4. Baseline NIHSS (at the time of randomization) should be ≥5 and ≤25 points; 5. Pre-stroke mRS score≤1 points; 6. Informed consent from the patient or surrogate. Exclusion Criteria: 1. Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural/extradural hematoma, etc.); 2. Past history of intracranial hemorrhage; 3. Rapid neurological function improvement, NIHSS score less than 5 points; 4. Presence of proximal arterial occlusion on computed tomographic angiography(CTA)/magnetic resonance angiography(MRA) (e.g., intracranial internal carotid artery(ICA), middle cerebral artery(MCA)-M1, and vertebrobasilar arteries); 5. Massive anterior cerebral infarction identified by CT or MRI (ASPECT \< 6 or lesions larger than one third of the territory of the middle cerebral artery); 6. Intended to proceed endovascular treatment; 7. Pregnant women, or planning to become pregnant during the trial; 8. A history of severe head trauma or stroke within 3 months; 9. A history of intracranial or spinal surgery within 3 months; 10. A history of gastrointestinal or urinary bleeding within 3 weeks; 11. two weeks of major surgery; 12. Arterial puncture was performed at the hemostasis site that was not easily compressed within 1 week; 13. Active visceral bleeding; 14. Intracranial tumors, large intracranial aneurysms; 15. Aortic arch dissection was found; 16. Severe, sustained hypertension (Systolic Blood Pressure \>185 mmHg or Diastolic Blood Pressure \>110 mmHg); 17. Baseline blood glucose of \<50mg/dL (2.78 mmol) or \>400mg/dL (22.20 mmol); 18. Oral warfarin anticoagulant with international normalized ratio(INR)\>1.7 or prothrombin time(PT)\>15 s; 19. Heparin treatment was received within 24 h; 20. Thrombin inhibitors or factor Xa inhibitors were used within 48 h; 21. Propensity for acute bleeding, including platelet counts of less than 100×109/ L or otherwise; 22. Hereditary or acquired bleeding constitution; 23. Onset with seizures; 24. Severe liver and kidney dysfunction; 25. Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome; 26. Patients with anemia or polycythemia vera or other situations that require urgent oxygen inhalation; 27. Patients with upper gastrointestinal bleeding or nausea or vomiting so that they cannot cooperate with the mask to inhale oxygen; 28. Life expectancy \< 1 year; 29. Patients who could not complete the 90-day follow-up; 30. Participation in other clinical trials within 3 months prior to screening; 31. Unsuitability or participation in this study as judged by the Investigator may result in subjects being exposed to greater risk.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Xuan Wu Hospital,Capital Medical University
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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