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Not yet recruiting NCT07129486

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

Observational Obstructive Sleep Apnea (OSA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CPAP.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea (OSA). Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Primary outcome measures

  • NET activity of neutrophils induced by PMA [Time frame: From enrollment to receiving CPAP therapy for 3 months]
  • DNA-MPO (Myeloperoxidase) complex in plasma [Time frame: From enrollment to receiving CPAP therapy for 3 months]
  • LL-37 level in plasma [Time frame: From enrollment to receiving CPAP therapy for 3 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Taiwan · 1 center
  • Taipei Veterans General Hospital — Taipei

Identifiers

NCT: NCT07129486 · 2025-02-007BC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗