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NCT Number: NCT07129486

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

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.

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP

Device

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

Primary outcomes

  1. NET activity of neutrophils induced by PMA

    Time frame: From enrollment to receiving CPAP therapy for 3 months

    10 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).

  2. DNA-MPO (Myeloperoxidase) complex in plasma

    Time frame: From enrollment to receiving CPAP therapy for 3 months

    Description: 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).

  3. LL-37 level in plasma

    Time frame: From enrollment to receiving CPAP therapy for 3 months

    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 LL-37 by ELISA (Enzyme-linked immunosorbent assay).

Other outcomes

  1. LL-37 in the supernatant of cultured neutrophils

    Time frame: From enrollment to receiving CPAP therapy for 3 months

    10 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.

  2. MPO (Myeloperoxidase) in the supernatant of cultured neutrophils

    Time frame: From enrollment to receiving CPAP therapy for 3 months

    10 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.

  3. NE (Neutrophil elastase) in the supernatant of cultured neutrophils

    Time frame: From enrollment to receiving CPAP therapy for 3 months

    10 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kun-Ta Chou, M.D & Ph.D

CONTACT

[email protected]

:(886)-2-2871-2121 ext. 83085

Sponsors and collaborators

Lead sponsor

Kun-Ta Chou

Other Gov

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 19, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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