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

NCT07129486 | Not Yet Recruiting

• 1 other identifier: 2025-02-007BC
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

sleep apnea; intermittent hypoxia; neutrophil extracellular traps; cathelicidins

Outcome Measures

Primary Outcomes (3)

• NET activity of neutrophils induced by PMA

  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).

  From enrollment to receiving CPAP therapy for 3 months

• DNA-MPO (Myeloperoxidase) complex in plasma

  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).

  From enrollment to receiving CPAP therapy for 3 months

• LL-37 level in plasma

  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).

  From enrollment to receiving CPAP therapy for 3 months

Other Outcomes (3)

• LL-37 in the supernatant of cultured neutrophils

  From enrollment to receiving CPAP therapy for 3 months

• MPO (Myeloperoxidase) in the supernatant of cultured neutrophils

  From enrollment to receiving CPAP therapy for 3 months

• NE (Neutrophil elastase) in the supernatant of cultured neutrophils

  From enrollment to receiving CPAP therapy for 3 months

Study Arms (2)

OSA

participants with OSA

Device: CPAP

Control

Participants without OSA

Interventions

CPAP DEVICE

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

OSA

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderate-to-Severe OSA

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kun-Ta Chou: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taipei, 112, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum/Plasma.

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

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

CONTACT

:(886)-2-2871-2121; hbjoue@vghtpe.gov.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TW (1)