Obstructive Sleep Apnea (OSA)NCT07129486
Intermittent-Hypoxia Inhibits Neutrophil Extracellular Traps Formation: Role of Cathelicidins
An observational study of Obstructive Sleep Apnea (OSA), run by Kun-Ta Chou at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2025to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Moderate-to-Severe OSA
Who may be able to join
- At least 20 years old, with moderate to severe OSA (AHI ≥ 15/hour), and willing to participate in the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taipei Veterans General Hospital
Taipei, Taipei, 112
0922407055, ale1371@yahoo.com.tw
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- CPAP
- Keywords
- sleep apnea, intermittent hypoxia, neutrophil extracellular traps, cathelicidins
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Continuous positive airway pressure (CPAP) is the standard treatment for moderate to severe OSA in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| OSA | participants with OSA Receives: Device: CPAP | |
| Control | Participants without OSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: From enrollment to receiving CPAP therapy for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kun-Ta Chou
- Sponsor type
- Other government
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor-investigator, Kun-Ta Chou, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129486
- Sponsor's protocol ID
- 2025-02-007BC
- Status last verified
- Sep 2025
- First submitted
- 12 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent-Hypoxia Inhibits Neutrophil Extracellular Traps Formation: Role of Cathelicidins
- ClinicalTrials.gov ID
- NCT07129486
- Acronym / sponsor ID
- 2025-02-007BC
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- sleep apnea, intermittent hypoxia, neutrophil extracellular traps, cathelicidins
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kun-Ta ChouOther government
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Sep 2025 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA | – | Device: CPAPparticipants with OSA |
| Control | – | –Participants without OSA |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Moderate-to-Severe OSA
Key inclusion criteria (1 listed)
- At least 20 years old, with moderate to severe OSA (AHI ≥ 15/hour), and willing to participate in the study.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPContinuous positive airway pressure (CPAP) is the standard treatment for moderate to severe OSA in clinical practice. | Device | OSA |
Primary outcome
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
Related trials for Obstructive Sleep Apnea (OSA)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA), run by Kun-Ta Chou at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kun-Ta Chou, M.D & Ph.D (:(886)-2-2871-2121 ext. 83085, hbjoue@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NET activity of neutrophils induced by PMA (time frame: From enrollment to receiving CPAP therapy for 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.