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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
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453697


Contacts
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Contact: Song Liu, M.d., Ph.D. 8613061966956 liusongyy@hotmail.com
Contact: Tianyun Yang, M.M 861380865025 13801865025@163.com

Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Study Director: Song Liu, M.d., Ph.D. Shanghai Jiao Tong University School of Medicine

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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03453697     History of Changes
Other Study ID Numbers: XH-17-016
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
Intermittent Hypoxemia
diffusion tensor imaging
oxidative stress
Additional relevant MeSH terms:
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Inflammation
Hypoxia
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms