Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Cerebral Hypoperfusion
- Sponsor
- Capital Medical University
- Enrollment
- 20
- Primary Endpoint
- Incidence of adverse reactions
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
This study aims to investigate the safety and efficacy of intermittent hypoxia treatment in patients with chronic cerebral hypoperfusion.
Detailed Description
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.
Investigators
Ji Xunming,MD,PhD
Principal Investigator
Capital Medical University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Incidence of adverse reactions
Time Frame: Thirty days after the treatment.
Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness (according to the Lake Louise scoring system), and insomnia.
Secondary Outcomes
- Neurobehavioral scale 1(Baseline, after the 7-day treatment.)
- Neurobehavioral scale 2(Baseline, after the 7-day treatment.)
- Cerebral blood flow(Baseline, after the 7-day treatment.)
- Tissue oxygen saturation(Baseline, after the 7-day treatment, 30 days after the treatment.)
- Blood pressure(Baseline, after the 7-day treatment, 30 days after the treatment.)