Effects of Acute Intermittent Hypoxia on Brain Function Imaging and Systemic Inflammation
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|ClinicalTrials.gov Identifier: NCT03453697|
Recruitment Status : Not yet recruiting
First Posted : March 5, 2018
Last Update Posted : April 9, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypoxemia||Device: acute intermittent hypoxia||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Acute Intermittent Hypoxia on Brain Function Imaging and Systemic Inflammation|
|Estimated Study Start Date :||November 1, 2020|
|Estimated Primary Completion Date :||November 1, 2023|
|Estimated Study Completion Date :||November 1, 2023|
Experimental: acute intermittent hypoxia
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.
Device: acute intermittent hypoxia
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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453697
|Contact: Song Liu, M.d., Ph.D.||firstname.lastname@example.org|
|Contact: Tianyun Yang, M.Memail@example.com|
|Study Director:||Song Liu, M.d., Ph.D.||Shanghai Jiao Tong University School of Medicine|