Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion

Study Overview
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Brief Summary
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This study aims to investigate the safety and efficacy of intermittent hypoxia treatment in patients with chronic cerebral hypoperfusion.

Detailed Description
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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.

Official Title
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Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion

Conditions
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Chronic Cerebral Hypoperfusion

Intervention / Treatment
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* Other: Intermittent Hypoxia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects aged 45-70 years, BMI 18.5-24kg/m2, both sexes. Subjects with risk factors of cerebrovascular disease, such as hypertension, diabetes, dyslipidemia, and so on, and the risk factors are well controlled. Cerebral/carotid ultrasound showed mild stenosis of unilateral internal carotid artery (ICA) or middle cerebral artery (MCA) (<50%) without stenosis of other major feeding arteries. Subjects with the manifestations of chronic cerebral hypoperfusion, such as dizziness, head pain, memory loss, slow reaction, inattention, emotional instability, decreased ability to work, sleep disorders and mood disorders, the course of more than 3 months. Subjects or their legally authorized representative can provide informed consent. Exclusion Criteria: Stroke onset in the past 3 months, other severe neurological diseases, such as epilepsy, intracranial infectious diseases or demyelination. Uncontrolled hypertension (systolic blood pressure ≥200mmHg) with antihypertensive drugs before enrollment, other cardiovascular diseases. History of pulmonary, hepatic, dermatologic, or hematologic diseases. History of substance abuse. Pregnancy, hypertension, diabetes mellitus, obesity, sleep apnea and neurological disorders.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>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. | Other: Intermittent Hypoxia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. |