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This study aims to investigate the safety and efficacy of intermittent hypoxia treatment in patients with chronic cerebral hypoperfusion.
Chronic cerebral hypoperfusion is a common and frequently occurring disease in middle-aged and senior people, and an important cause of multiple diseases such as acute ischemic stroke and vascular dementia. However, current treatments for chronic cerebral hypoperfusion are limited and nonspecific. Intermittent hypoxia refers to periodic intervention with alternating normoxia and hypoxia. Studies have shown that short-term (5-10min), low frequency (3-15 times), and mild to moderate hypoxia (9-16%) usually have protective effects and can improve cerebral blood perfusion. Therefore, this study is an exploratory study combining intermittent hypoxia treatment with chronic cerebral hypoperfusion, aiming to preliminarily explore the safety and potential effectiveness of intermittent hypoxia treatment in the using of chronic cerebral hypoperfusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Experimental | The intermittent hypoxia protocol refers to four cycles of 5 minutes hypoxia inhaling interval by 5 minutes normoxia, which is performed twice a day (at least 6 hours apart) in 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Hypoxia | Other | The intermittent hypoxia protocol refers to four cycles of 5 minutes hypoxia inhaling interval by 5 minutes normoxia, which is performed twice a day (at least 6 hours apart) in 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse reactions | Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness (according to the Lake Louise scoring system), and insomnia. | After the 7-day treatment. |
| Incidence of adverse reactions | Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness (according to the Lake Louise scoring system), and insomnia. | Thirty days after the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue oxygen saturation | Including peripheral oxygen saturation and brain tissue oxygen saturation (%). | Baseline, after the 7-day treatment, 30 days after the treatment. |
| Cerebral blood flow |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan Wang, M.D. | Contact | +86-135 8156 7815 | wilma0106@163.com |
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Cerebral blood flow will be detected by transcranial color-coded duplex sonography.
| Baseline, after the 7-day treatment. |
| Neurobehavioral scale 1 | It is evaluated by scales of Mini-mental State Examination (MMSE), which ranges from 0-30 points, and higher scores mean a worse outcome. | Baseline, after the 7-day treatment. |
| Blood pressure | Including systolic blood pressure and diastolic blood pressure (mmHg). | Baseline, after the 7-day treatment, 30 days after the treatment. |
| Neurobehavioral scale 2 | It is evaluated by scales of Montreal Cognitive Assessment (MoCA), which ranges from 0-30 points, and higher scores mean a worse outcome. | Baseline, after the 7-day treatment. |