Clinical trial NCT05824104: Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion
Official title: Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Cerebral Hypoperfusion
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 20
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Incidence of adverse reactions
timeFrame: After the 7-day treatment.
measure: Incidence of adverse reactions
timeFrame: Thirty days after the treatment.
Secondary outcomes:
measure: Tissue oxygen saturation
timeFrame: Baseline, after the 7-day treatment, 30 days after the treatment.
measure: Cerebral blood flow
timeFrame: Baseline, after the 7-day treatment.
measure: Neurobehavioral scale 1
timeFrame: Baseline, after the 7-day treatment.
measure: Blood pressure
timeFrame: Baseline, after the 7-day treatment, 30 days after the treatment.
measure: Neurobehavioral scale 2
timeFrame: Baseline, after the 7-day treatment.
Other outcomes:
Locations:
Study officials:
References: