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Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion

Primary Purpose

Chronic Cerebral Hypoperfusion

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intermittent Hypoxia
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Cerebral Hypoperfusion

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Patients

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Incidence of adverse reactions
    Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness (according to the Lake Louise scoring system), and insomnia.
    Incidence of adverse reactions
    Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness (according to the Lake Louise scoring system), and insomnia.

    Secondary Outcome Measures

    Tissue oxygen saturation
    Including peripheral oxygen saturation and brain tissue oxygen saturation (%).
    Cerebral blood flow
    Cerebral blood flow will be detected by transcranial color-coded duplex sonography.
    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.
    Blood pressure
    Including systolic blood pressure and diastolic blood pressure (mmHg).
    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.

    Full Information

    First Posted
    March 28, 2023
    Last Updated
    April 24, 2023
    Sponsor
    Capital Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05824104
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 10, 2023 (Anticipated)
    Primary Completion Date
    September 10, 2023 (Anticipated)
    Study Completion Date
    October 10, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Capital Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Cerebral Hypoperfusion

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Intermittent Hypoxia
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incidence of adverse reactions
    Description
    Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness (according to the Lake Louise scoring system), and insomnia.
    Time Frame
    After the 7-day treatment.
    Title
    Incidence of adverse reactions
    Description
    Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness (according to the Lake Louise scoring system), and insomnia.
    Time Frame
    Thirty days after the treatment.
    Secondary Outcome Measure Information:
    Title
    Tissue oxygen saturation
    Description
    Including peripheral oxygen saturation and brain tissue oxygen saturation (%).
    Time Frame
    Baseline, after the 7-day treatment, 30 days after the treatment.
    Title
    Cerebral blood flow
    Description
    Cerebral blood flow will be detected by transcranial color-coded duplex sonography.
    Time Frame
    Baseline, after the 7-day treatment.
    Title
    Neurobehavioral scale 1
    Description
    It is evaluated by scales of Mini-mental State Examination (MMSE), which ranges from 0-30 points, and higher scores mean a worse outcome.
    Time Frame
    Baseline, after the 7-day treatment.
    Title
    Blood pressure
    Description
    Including systolic blood pressure and diastolic blood pressure (mmHg).
    Time Frame
    Baseline, after the 7-day treatment, 30 days after the treatment.
    Title
    Neurobehavioral scale 2
    Description
    It is evaluated by scales of Montreal Cognitive Assessment (MoCA), which ranges from 0-30 points, and higher scores mean a worse outcome.
    Time Frame
    Baseline, after the 7-day treatment.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuan Wang, M.D.
    Phone
    +86-135 8156 7815
    Email
    wilma0106@163.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion

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