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

NCT ID: NCT07129486

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-07-31

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea (OSA)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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OSA

participants with OSA

CPAP

Intervention Type DEVICE

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

Control

Participants without OSA

No interventions assigned to this group

Interventions

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CPAP

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role collaborator

Kun-Ta Chou

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kun-Ta Chou

Chief

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Taipei Veterans General Hospital

Taipei, Taipei, Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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

Role: CONTACT

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

Facility Contacts

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Role: primary

0922407055

Other Identifiers

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2025-02-007BC

Identifier Type: -

Identifier Source: org_study_id

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