HypoxemiaNCT03453697
Effects of Acute Intermittent Hypoxia on Brain Function Imaging and Systemic Inflammation
A study testing acute intermittent hypoxia in people with Hypoxemia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
Effects of acute intermittent hypoxia on brain function imaging and systemic inflammation Patients with obstructive sleep apnea (OSAS) may have neurological cognitive impairment. The reason is not clear. Intermittent hypoxia is one of the main manifestations of OSAS. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoxemia
- What is being tested?
- acute intermittent hypoxia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 1 Nov 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers between 18 and 50 years old, no physical abnormalities
- Without both smoking and drinking habits
- Without the following symptoms: heart, lung, liver, kidney, and thyroid diseases; neuropsychiatric disorders, diabetes history; histories of craniocerebral surgery and tumor disease; recent acute infectious disease (2 weeks); diseases of chronic systemic infection and inflammation
- BMI index in the normal range
- Without snoring and sleep apnea
- No metal in vivo implantation
Who cannot join
- Diseases such as OSAS or other sleep apnea
- Recent craniocerebral trauma (1 month)
- Alcohol abuse and psychotropic drugs
- EKG checking abnormality or previous history of chest tightness palpitations
Trial locations and contacts
No sites are listed yet.
About this study
Effects of acute intermittent hypoxia on brain function imaging and systemic inflammation
Patients with obstructive sleep apnea (OSAS) may have neurological cognitive impairment. The reason is not clear. Intermittent hypoxia is one of the main manifestations of OSAS.
Read more
The investigators hypothesize that acute intermittent hypoxia (AIH) can lead to abnormal metabolic activity in some regions of the brain, which may be associated with systemic inflammation.
The investigators proposed in 12 to 15 cases of healthy volunteers, in the form of breathing in the nitrogen intermittently, were observed before and after AIH MRI diffusion tensor imaging (DTI) changes in brain regions and at the same time understand the inflammatory factors and the change of oxidative stress in the human body.
The investigators look at the data from different brain regions of the brain DTI anisotropic score (FA), radial diffusion coefficient (RD), axial diffusion coefficient (AD) and peripheral blood interleukin-6 (IL - 6), interleukin-8 (IL - 8), interleukin-10(IL - 10), tumor necrosis factor alpha (TNF-α), Interleukin-1 beta (IL-1β), Leptin, high sensitivity reactive protein(hsCRP), Intercellular Adhesion Molecule 1(ICAM 1),Vascular cell adhesion protein 1(VCAM-1) , E-selectin, endothelin-1(ET - 1), 8-iso-PGF2α,3-nitrotyrosine(3-NT),hypoxia-inducible factor 1α(HIF 1α).
Statistical data processing includes: the matching t test of the above indicators before and after AIH; The relationship between DTI and peripheral blood inflammatory factors was analyzed by single factor. Using DTI as the dependent variable, the peripheral blood inflammatory factor was analyzed by multifactor correlation.
Ultimately, the effect of AIH on the brain's regional functions will be understood, and whether the effect is related to systemic inflammation.
Read the detailed description
In this study, the potential risks to subjects and their corresponding prevention measures:
- During the test, the volunteers may feel mild sleepiness due to oxygen. (Countermeasures: the subjects have a rest in bed, avoid activity, carry out the whole-process pulse oxygen and heart-rate blood pressure monitoring, and have the full care of the practicing physician)
- Venous blood is extracted pre- and post-test, and a few subjects may have halo bloody phenomenon. (Countermeasures: inform, select and remove the halo blood volunteers prior to test.)
- During the test, two MRI scans were performed and each was 20 minutes; the duration was longer than the general MRI (no risk).
Judging criteria for adverse events： According to researchers' own experiment, the low oxygen state had no adverse effects on the body or had only slight fatigue and somnolence, which could be improved after inhaling oxygen.
Plan to recruit and enroll 15 healthy volunteers Group time: March 2018 to March 2019 Follow-up time: the last volunteer was followed up for 1 month after completing the test.
Testing method：
- Smoking, alcohol drinking, overeating, staying up late were all prohibited one week before the test.
- The recruiter came to the test center on the testing morning, and the blood was extracted to check the following: blood routine, hsCRP, blood IL-6, IL-8, TNF-α, IL-1β, leptin , ICAM-1, VCAM-1, E-selectin, ET-1, etc. The doctor will check volunteers' EKG as well as their blood pressure, heart rate, respiration rate, blood oxygen saturation (when inhaling air). The first DTI was scanned and also process their dataset.
- Then, the test formally started and immediately entered the intermittent hypoxia cycle: With a mouth-nose mask, which can adjust the proportion of nitrogen and oxygen, the doctor could monitor the blood oxygen saturation; through increasing the suction nitrogen concentration, the subject's blood oxygen saturation could decrease to 80%~90% within 30 seconds and also lasts 30 seconds; then quickly reduce the concentration of nitrogen gas suction to make the subject's blood oxygen saturation gradually return to normal level (consistent with the air inhalation), and then continue breathing air about 60 seconds to enter the next round of hypoxic state.
Through adjusting the inhaled nitrogen concentration in patients, the patients could be simulated as the OSA patients who had intermittent hypoxic state due to upper airway collapse at night. This process is equivalent to AIH 25-30 times/h, which is clinically intermediate to severe OSA.
The subjects always keep quiet and undisturbed during the experiment. The low oxygen cycle totally lasted six hours.
4．Subsequently, the subjects repeated the relevant blood tests (Experiment 2) and related checks, and accepted the second DTI scan for comparison with the first scan.
All blood samples in the test are backup. If the testing results appeared obvious abnormality, they can be reviewed immediately. The MRI examination before and after hypoxia was completed on the same day of the test and immediately uploaded to the imaging system, so there would be no data loss. If the subjects felt uncomfortable during the test, they could quit the test at any time. The investigators will re-recruit new qualified participants to carry out the test.
Statistical data processing includes: (1) the paired t-test with the above indicators pre- and post-AIH; (2) the relationship between DTI measures and peripheral blood inflammatory factors by single factor analysis. (3) Using DTI as the dependent variable and the peripheral blood inflammatory factor as the independent variable, multifactor correlation was analyzed.
- Conditions
- Hypoxemia
- Being tested
- acute intermittent hypoxia
- Keywords
- Intermittent Hypoxemia, diffusion tensor imaging, oxidative stress
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acute intermittent hypoxiaDevice
Adjust the proportion of nitrogen and oxygen, through increasing the suction nitrogen concentration, the subject's blood oxygen saturation could decrease to 80%~90% within 30 seconds and also lasts 30 seconds; then quickly reduce the concentration of nitrogen gas suction to make the subject's blood oxygen saturation gradually return to normal level (consistent with the air inhalation), and then continue breathing air about 60 seconds to enter the next round of hypoxic state.
| Study group | Role | What they receive |
|---|---|---|
| acute intermittent hypoxia | Experimental | Adjust the proportion of nitrogen and oxygen, through increasing the suction nitrogen concentration, the subject's blood oxygen saturation could decrease to 80%~90% within 30 seconds and also lasts 30 seconds; then quickly reduce the concentration of nitrogen gas suction to make the subject's blood oxygen saturation gradually return to normal level (consistent with the air inhalation), and then continue breathing air about 60 seconds to enter the next round of hypoxic state.Through adjusting the inhaled nitrogen concentration in patients, the patients could be simulated as the OSA patients who had intermittent hypoxic state due to upper airway collapse at night. This process is equivalent to acute intermittent hypoxia 25-30 times/h, which is clinically intermediate to severe OSA. Receives: Device: acute intermittent hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional anisotropy
Fractional anisotropy (FA) is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. FA is a measure often used in diffusion imaging where it is thought to reflect fiber density, axonal diameter, and myelination in white matter. The FA is an extension of the concept of eccentricity of conic sections in 3 dimensions, normalized to the unit range.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start1 Nov 2020 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies of the same condition, open and under way.
- 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Song Liu, M.d., Ph.D., Study director, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453697
- Sponsor's protocol ID
- XH-17-016
- Status last verified
- Apr 2019
- First submitted
- 7 Feb 2018
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- 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 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Intermittent Hypoxia on Brain Function Imaging and Systemic Inflammation
- ClinicalTrials.gov ID
- NCT03453697
- Acronym / sponsor ID
- XH-17-016
- Conditions
- Hypoxemia
- Keywords
- Intermittent Hypoxemia, diffusion tensor imaging, oxidative stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 5 Mar 2018 (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.
Effects of acute intermittent hypoxia on brain function imaging and systemic inflammation
Patients with obstructive sleep apnea (OSAS) may have neurological cognitive impairment. The reason is not clear. Intermittent hypoxia is one of the main manifestations of OSAS.
The investigators hypothesize that acute intermittent hypoxia (AIH) can lead to abnormal metabolic activity in some regions of the brain, which may be associated with systemic inflammation.
The investigators proposed in 12 to 15 cases of healthy volunteers, in the form of breathing in the nitrogen intermittently, were observed before and after AIH MRI diffusion tensor imaging (DTI) changes in brain regions and at the same time understand the inflammatory factors and the change of oxidative stress in the human body.
The investigators look at the data from different brain regions of the brain DTI anisotropic score (FA), radial diffusion coefficient (RD), axial diffusion coefficient (AD) and peripheral blood interleukin-6 (IL - 6), interleukin-8 (IL - 8), interleukin-10(IL - 10), tumor necrosis factor alpha (TNF-α), Interleukin-1 beta (IL-1β), Leptin, high sensitivity reactive protein(hsCRP), Intercellular Adhesion Molecule 1(ICAM 1),Vascular cell adhesion protein 1(VCAM-1) , E-selectin, endothelin-1(ET - 1), 8-iso-PGF2α,3-nitrotyrosine(3-NT),hypoxia-inducible factor 1α(HIF 1α).
Statistical data processing includes: the matching t test of the above indicators before and after AIH; The relationship between DTI and peripheral blood inflammatory factors was analyzed by single factor. Using DTI as the dependent variable, the peripheral blood inflammatory factor was analyzed by multifactor correlation.
Ultimately, the effect of AIH on the brain's regional functions will be understood, and whether the effect is related to systemic inflammation.
Detailed description
In this study, the potential risks to subjects and their corresponding prevention measures:
- During the test, the volunteers may feel mild sleepiness due to oxygen. (Countermeasures: the subjects have a rest in bed, avoid activity, carry out the whole-process pulse oxygen and heart-rate blood pressure monitoring, and have the full care of the practicing physician)
- Venous blood is extracted pre- and post-test, and a few subjects may have halo bloody phenomenon. (Countermeasures: inform, select and remove the halo blood volunteers prior to test.)
- During the test, two MRI scans were performed and each was 20 minutes; the duration was longer than the general MRI (no risk).
Judging criteria for adverse events： According to researchers' own experiment, the low oxygen state had no adverse effects on the body or had only slight fatigue and somnolence, which could be improved after inhaling oxygen.
Plan to recruit and enroll 15 healthy volunteers Group time: March 2018 to March 2019 Follow-up time: the last volunteer was followed up for 1 month after completing the test.
Testing method：
- Smoking, alcohol drinking, overeating, staying up late were all prohibited one week before the test.
- The recruiter came to the test center on the testing morning, and the blood was extracted to check the following: blood routine, hsCRP, blood IL-6, IL-8, TNF-α, IL-1β, leptin , ICAM-1, VCAM-1, E-selectin, ET-1, etc. The doctor will check volunteers' EKG as well as their blood pressure, heart rate, respiration rate, blood oxygen saturation (when inhaling air). The first DTI was scanned and also process their dataset.
- Then, the test formally started and immediately entered the intermittent hypoxia cycle: With a mouth-nose mask, which can adjust the proportion of nitrogen and oxygen, the doctor could monitor the blood oxygen saturation; through increasing the suction nitrogen concentration, the subject's blood oxygen saturation could decrease to 80%~90% within 30 seconds and also lasts 30 seconds; then quickly reduce the concentration of nitrogen gas suction to make the subject's blood oxygen saturation gradually return to normal level (consistent with the air inhalation), and then continue breathing air about 60 seconds to enter the next round of hypoxic state.
Through adjusting the inhaled nitrogen concentration in patients, the patients could be simulated as the OSA patients who had intermittent hypoxic state due to upper airway collapse at night. This process is equivalent to AIH 25-30 times/h, which is clinically intermediate to severe OSA.
The subjects always keep quiet and undisturbed during the experiment. The low oxygen cycle totally lasted six hours.
4．Subsequently, the subjects repeated the relevant blood tests (Experiment 2) and related checks, and accepted the second DTI scan for comparison with the first scan.
All blood samples in the test are backup. If the testing results appeared obvious abnormality, they can be reviewed immediately. The MRI examination before and after hypoxia was completed on the same day of the test and immediately uploaded to the imaging system, so there would be no data loss. If the subjects felt uncomfortable during the test, they could quit the test at any time. The investigators will re-recruit new qualified participants to carry out the test.
Statistical data processing includes: (1) the paired t-test with the above indicators pre- and post-AIH; (2) the relationship between DTI measures and peripheral blood inflammatory factors by single factor analysis. (3) Using DTI as the dependent variable and the peripheral blood inflammatory factor as the independent variable, multifactor correlation was analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute intermittent hypoxia | Experimental | Device: acute intermittent hypoxiaAdjust the proportion of nitrogen and oxygen, through increasing the suction nitrogen concentration, the subject's blood oxygen saturation could decrease to 80%~90% within 30 seconds and also lasts 30 seconds; then quickly reduce the concentration of nitrogen gas suction to make the subject's blood oxygen saturation gradually return to normal level (consistent with the air inhalation), and then continue breathing air about 60 seconds to enter the next round of hypoxic state.Through adjusting the inhaled nitrogen concentration in patients, the patients could be simulated as the OSA patients who had intermittent hypoxic state due to upper airway collapse at night. This process is equivalent to acute intermittent hypoxia 25-30 times/h, which is clinically intermediate to severe OSA. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy volunteers between 18 and 50 years old, no physical abnormalities
- Without both smoking and drinking habits
- Without the following symptoms: heart, lung, liver, kidney, and thyroid diseases; neuropsychiatric disorders, diabetes history; histories of craniocerebral surgery and tumor disease; recent acute infectious disease (2 weeks); diseases of chronic systemic infection and inflammation
- BMI index in the normal range
- Without snoring and sleep apnea
Key exclusion criteria (4 listed)
- Diseases such as OSAS or other sleep apnea
- Recent craniocerebral trauma (1 month)
- Alcohol abuse and psychotropic drugs
- EKG checking abnormality or previous history of chest tightness palpitations
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 |
|---|---|---|
| acute intermittent hypoxiaAdjust the proportion of nitrogen and oxygen, through increasing the suction nitrogen concentration, the subject's blood oxygen saturation could decrease to 80%~90% within 30 seconds and also lasts 30 seconds; then quickly reduce the concentration of nitrogen gas suction to make the subject's blood oxygen saturation gradually return to normal level (consistent with the air inhalation), and then continue breathing air about 60 seconds to enter the next round of hypoxic state. | Device | acute intermittent hypoxia |
Primary outcome
Fractional anisotropy
Time frame: One year
Fractional anisotropy (FA) is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. FA is a measure often used in diffusion imaging where it is thought to reflect fiber density, axonal diameter, and myelination in white matter. The FA is an extension of the concept of eccentricity of conic sections in 3 dimensions, normalized to the unit range.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- 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.
Song Liu, M.d., Ph.D. study director
Shanghai Jiao Tong University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing acute intermittent hypoxia in people with Hypoxemia, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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 6 inclusion and 4 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 9 Apr 2019. 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 Song Liu, M.d., Ph.D. (8613061966956, liusongyy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional anisotropy (time frame: One year). 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 9 Apr 2019.