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NCT03453697
Effects of Acute Intermittent Hypoxia on Brain Function Imaging and Systemic Inflammation
NA trial testing acute intermittent hypoxia in Hypoxemia in 15 participants. Status unknown.
1 November 2023
Quick facts
| Lead sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 15 |
| Start date | 1 November 2020 |
| Primary completion | 1 November 2023 |
| Estimated completion | 1 November 2023 |
Drugs / interventions tested
- acute intermittent hypoxia
Conditions studied
- Hypoxemia — all drugs for Hypoxemia →
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Who can join
Adults 18 to 50, any sex, with Hypoxemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03453697 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Last refreshed: 9 April 2019
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