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Intermittent-Hypoxia Inhibits Neutrophil Extracellular Traps Formation: Role of Cathelicidins

Intermittent-Hypoxia Inhibits Neutrophil Extracellular Traps Formation: Role of Cathelicidins

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07129486
Enrollment
120
Registered
2025-08-19
Start date
2025-09-30
Completion date
2028-07-31
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

sleep apnea, intermittent hypoxia, neutrophil extracellular traps, cathelicidins

Brief summary

The study will enroll 80 moderate-to-severe Obstructive sleep apnea (OSA) patients (40 obese) and 40 age-, gender-, and body mass index-matched controls. Venous blood will be collected to isolate neutrophils, which will be tested for the ability to produce neutrophil extracellular traps (NETs) along with the levels of LL-37 and NETs products in the blood. Measurements will be repeat after three months treatment for OSA.

Detailed description

Obstructive sleep apnea (OSA) is characterized by repetitive upper airway collapse during sleep, thereby leading to intermittent hypoxia (IH). Literature revealed OSA confers a higher risk for poor infection outcomes, suggestive of defective immunity in those patients. This research aimed to investigate whether IH inhibits neutrophils to produce neutrophil extracellular traps (NETs) via Cathelicidins (LL-37). The human study will enroll 80 moderate-to-severe OSA patients (40 obese) and 40 age-, gender-, and body mass index-matched controls. Venous blood will be collected to isolate neutrophils, which receive either IH treatment (1% O2 for 35 mins and 21% for 25 mins per cycle, 3 cycles) or normoxic treatment. The neutrophils will be tested for the ability to produce NETs along with the levels of LL-37 and NETs products in the blood. Measurements will be repeat three months after the mainstay continuous positive airway pressure (CPAP) therapy.

Interventions

DEVICECPAP

Continuous positive airway pressure (CPAP) is the standard treatment for moderate to severe OSA in clinical practice.

Sponsors

National Science and Technology Council, Taiwan
CollaboratorOTHER_GOV
Kun-Ta Chou
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* At least 20 years old, with moderate to severe OSA (AHI ≥ 15/hour), and willing to participate in the study.

Exclusion criteria

* Under 20 years old, suffering from diseases or conditions that may affect immune function (e.g., tumors, chemotherapy, autoimmune diseases, diabetes, chronic kidney disease, etc.), or unwilling to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
NET activity of neutrophils induced by PMAFrom enrollment to receiving CPAP therapy for 3 months10 cc peripheral venous blood of participants will be collected at enrollment and 3 months after CPAP therapy (if received it). Neutrophils are isolated from peripheral blood and stimulated with PMA (phorbol 12-myristate 13-acetate) to induce the formation of NETs. The effects were tested with or without intermittent hypoxia (IH) treatment (1% O₂ for 35 minutes followed by 21% O₂ for 25 minutes per cycle, repeated for three cycles). The extent of NETs formation was assessed by confocal microscopy and images were exported as multi-channel TIFF files and analyzed using custom Python scripts (NumPy, scikit-image).
DNA-MPO (Myeloperoxidase) complex in plasmaFrom enrollment to receiving CPAP therapy for 3 monthsDescription: 10 cc peripheral venous blood of participants will be collected at enrollment and 3 months after CPAP therapy (if received it). Plasma is collected and tested for DNA-MPO (Myeloperoxidase) complex by ELISA (Enzyme-linked immunosorbent assay).
LL-37 level in plasmaFrom enrollment to receiving CPAP therapy for 3 months10 cc peripheral venous blood of participants will be collected at enrollment and 3 months after CPAP therapy (if received it). Plasma is collected and tested for LL-37 by ELISA (Enzyme-linked immunosorbent assay).

Other

MeasureTime frameDescription
LL-37 in the supernatant of cultured neutrophilsFrom enrollment to receiving CPAP therapy for 3 months10 cc peripheral venous blood of participants will be collected at enrollment and 3 months after CPAP therapy (if received it). Neutrophils are isolated from peripheral blood and stimulated with PMA (phorbol 12-myristate 13-acetate) to induce the formation of NETs. Supernatant of cultured neutrophils are collected and tested for LL-37 by ELISA.
MPO (Myeloperoxidase) in the supernatant of cultured neutrophilsFrom enrollment to receiving CPAP therapy for 3 months10 cc peripheral venous blood of participants will be collected at enrollment and 3 months after CPAP therapy (if received it). Neutrophils are isolated from peripheral blood and stimulated with PMA (phorbol 12-myristate 13-acetate) to induce the formation of NETs. Supernatant of cultured neutrophils are collected and tested for MPO (Myeloperoxidase )by ELISA.
NE (Neutrophil elastase) in the supernatant of cultured neutrophilsFrom enrollment to receiving CPAP therapy for 3 months10 cc peripheral venous blood of participants will be collected at enrollment and 3 months after CPAP therapy (if received it). Neutrophils are isolated from peripheral blood and stimulated with PMA (phorbol 12-myristate 13-acetate) to induce the formation of NETs. Supernatant of cultured neutrophils are collected and tested for NE (Neutrophil elastase) by ELISA.

Countries

Taiwan

Contacts

Primary ContactKun-Ta Chou, M.D & Ph.D
hbjoue@vghtpe.gov.tw:(886)-2-2871-2121

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026