Chronic Cerebral HypoperfusionNCT05824104
Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion
A study testing Intermittent Hypoxia in people with Chronic Cerebral Hypoperfusion, run by Capital Medical University.
Trial summary
This study aims to investigate the safety and efficacy of intermittent hypoxia treatment in patients with chronic cerebral hypoperfusion. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Chronic Cerebral Hypoperfusion
- What is being tested?
- Intermittent Hypoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2023to 10 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
This study aims to investigate the safety and efficacy of intermittent hypoxia treatment in patients with chronic cerebral hypoperfusion.
Read the 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.
- Conditions
- Chronic Cerebral Hypoperfusion
- Being tested
- Intermittent Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent HypoxiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intermittent Hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse reactions
Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness (according to the Lake Louise scoring system), and insomnia.
Measured: 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.
Measured: Thirty days after the treatment.
Secondary outcomes (5)
Tissue oxygen saturation
Including peripheral oxygen saturation and brain tissue oxygen saturation (%).
Measured: 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.
Measured: 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.
Measured: Baseline, after the 7-day treatment.
Blood pressure
Including systolic blood pressure and diastolic blood pressure (mmHg).
Measured: 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.
Measured: Baseline, after the 7-day treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start10 May 2023 (estimated)
- Primary completion10 Sep 2023 (estimated)
- Study completion10 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Cerebral HypoperfusionStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824104
- Sponsor's protocol ID
- IH-CCH
- Status last verified
- Apr 2023
- First submitted
- 28 Mar 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion
- ClinicalTrials.gov ID
- NCT05824104
- Acronym / sponsor ID
- IH-CCH
- Conditions
- Chronic Cerebral Hypoperfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (estimated)
- Primary completion
- 10 Sep 2023 (estimated)
- Study completion
- 10 Oct 2023 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Intermittent HypoxiaThe 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. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent HypoxiaThe 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 | Patients |
Primary outcome
Incidence of adverse reactions
Time frame: After the 7-day treatment.
Adverse reactions included headache, vomiting, diarrhea, fatigue, dizziness (according to the Lake Louise scoring system), and insomnia.
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.
5 secondary outcomes
Tissue oxygen saturation
Time frame: Baseline, after the 7-day treatment, 30 days after the treatment.
Cerebral blood flow
Time frame: Baseline, after the 7-day treatment.
Neurobehavioral scale 1
Time frame: Baseline, after the 7-day treatment.
Blood pressure
Time frame: Baseline, after the 7-day treatment, 30 days after the treatment.
Neurobehavioral scale 2
Time frame: Baseline, after the 7-day treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Hypoxia in people with Chronic Cerebral Hypoperfusion, run by Capital Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan Wang, M.D. (+86-135 8156 7815, wilma0106@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse reactions (time frame: After the 7-day treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.