OSANCT05485688
Impact of Intermittent Hypoxia on Neutrophil Extracellular Traps
An observational study of OSA, run by Taipei Veterans General Hospital, Taiwan.
Trial summary
This prospective observational study will enroll 60 moderate-to-severe OSA patients (AHI≧15/hour, 30 obese [BMI>=27] \& 30 non-obese [BMI<27]) and 40 age-, gender-, BMI-matched controls without OSA. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- OSA
- What is being tested?
- sleep apnea
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: This prospective observational study will enroll 60 moderate-to-severe OSA patients (AHI≧15/hour, 30 obese [BMI>=27] \& 30 non-obese [BMI<27]) and 40 age-, gender-, BMI-matched controls without OSA. Venous blood 10 ml will be collected to isolate neutrophils, which are later tested for their ability to produce neutrophil extracellular traps (NETs) under the effect of PMA (phorbol 12-myristate 13-acetate).
Who may be able to join
- Adults with clinical diagnosis of moderate or severe OSA (AHI >=15/hour)
- Must be willing to participate in this study and sign permit
Who cannot join
- Not willing to participate in this study
- Ever treated with continous positive airway pressure (CPAP) or other therapy for OSA
- Age < 20 years
- Have comorbid disease or condition, which could impact immunity (such as malignancy, chemotherapy, immune disease, diabetes etc)
Trial locations and contacts
No sites are listed yet.
About this study
This prospective observational study will enroll 60 moderate-to-severe OSA patients (AHI≧15/hour, 30 obese [BMI>=27] \& 30 non-obese [BMI<27]) and 40 age-, gender-, BMI-matched controls without OSA. Venous blood 10 ml will be collected to isolate neutrophils, which are later tested for their ability to produce neutrophil extracellular traps (NETs) under the effect of PMA (phorbol 12-myristate 13-acetate). The test will be repeated if OSA patients receive CPAP therapy (continous positive airway pressure therapy).
Read the detailed description
Obstructive sleep apnea (OSA) is a common disease, affecting around one billion people worldwide. This disorder is characterized by repetitive upper airway collapse during sleep, thereby leading to intermittent hypoxia (IH). The severity of OSA is gauged by AHI(apnea-hypopnea index), which can be determined by a sleep test, polysomnography. Literature revealed OSA confers a higher risk for incident pneumonia and sepsis-related adverse outcomes, suggestive of defective immunity in those patients. CPAP therapy (continous positive airway pressure therapy) is the mainstay treatment for OSA. This research is aimed to investigate the impact of IH on the ability of neutrophils to produce neutrophil extracellular traps (NETs). We will enroll 60 moderate-to-severe OSA patients (AHI≧15/hour, 30 obese [BMI>=27] \& 30 non-obese [BMI<27]) and 40 age-, gender-, BMI-matched controls without OSA. Venous blood 10 ml will be collected to isolate neutrophils, which are later tested for their ability to produce NETs under the effect of PMA (phorbol 12-myristate 13-acetate).
- Conditions
- OSA
- Being tested
- sleep apnea
- Keywords
- obstructive sleep apnea, intermittent hypoxia, neutrophil extracellular traps
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleep apneaOther
This prospective observational study will enroll 60 moderate-to-severe OSA patients (AHI≧15/hour, 30 obese [BMI>=27] \& 30 non-obese [BMI<27]) and 40 age-, gender-, BMI-matched controls without OSA. Venous blood 10 ml will be collected to isolate neutrophils, which are later tested for their ability to produce neutrophil extracellular traps (NETs) under the effect of PMA (phorbol 12-myristate 13-acetate).
| Study group | Role | What they receive |
|---|---|---|
| Sleep apnea | 60 moderate-to-severe OSA patients (AHI≧15/hour, 30 obese [BMI>=27] \& 30 non-obese [BMI<27]) Receives: Other: sleep apnea | |
| Control | 40 age-, gender-, BMI-matched controls without OSA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ability to produce neutrophil extracellular traps (NETs)
Venous blood 10 ml will be collected to isolate neutrophils, which are later tested for their ability to produce neutrophil extracellular traps (NETs) under the effect of PMA (phorbol 12-myristate 13-acetate). The test will be repeated if OSA patients receive CPAP therapy (continous positive airway pressure therapy).
Measured: 0-90 dyas (if receive therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study startJan 2023 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Kun-Ta Chou, MD & Ph.D, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485688
- Sponsor's protocol ID
- 2022-01-034AC
- Status last verified
- Nov 2022
- First submitted
- 1 Aug 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intermittent Hypoxia on Neutrophil Extracellular Traps
- ClinicalTrials.gov ID
- NCT05485688
- Acronym / sponsor ID
- 2022-01-034AC
- Conditions
- OSA
- Keywords
- obstructive sleep apnea, intermittent hypoxia, neutrophil extracellular traps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- Jan 2023 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 3 Aug 2022 (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.
This prospective observational study will enroll 60 moderate-to-severe OSA patients (AHI≧15/hour, 30 obese [BMI>=27] \& 30 non-obese [BMI<27]) and 40 age-, gender-, BMI-matched controls without OSA. Venous blood 10 ml will be collected to isolate neutrophils, which are later tested for their ability to produce neutrophil extracellular traps (NETs) under the effect of PMA (phorbol 12-myristate 13-acetate). The test will be repeated if OSA patients receive CPAP therapy (continous positive airway pressure therapy).
Detailed description
Obstructive sleep apnea (OSA) is a common disease, affecting around one billion people worldwide. This disorder is characterized by repetitive upper airway collapse during sleep, thereby leading to intermittent hypoxia (IH). The severity of OSA is gauged by AHI(apnea-hypopnea index), which can be determined by a sleep test, polysomnography. Literature revealed OSA confers a higher risk for incident pneumonia and sepsis-related adverse outcomes, suggestive of defective immunity in those patients. CPAP therapy (continous positive airway pressure therapy) is the mainstay treatment for OSA. This research is aimed to investigate the impact of IH on the ability of neutrophils to produce neutrophil extracellular traps (NETs). We will enroll 60 moderate-to-severe OSA patients (AHI≧15/hour, 30 obese [BMI>=27] \& 30 non-obese [BMI<27]) and 40 age-, gender-, BMI-matched controls without OSA. Venous blood 10 ml will be collected to isolate neutrophils, which are later tested for their ability to produce NETs under the effect of PMA (phorbol 12-myristate 13-acetate).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep apnea | – | Other: sleep apnea60 moderate-to-severe OSA patients (AHI≧15/hour, 30 obese [BMI>=27] \& 30 non-obese [BMI<27]) |
| Control | – | –40 age-, gender-, BMI-matched controls without OSA. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective observational study will enroll 60 moderate-to-severe OSA patients (AHI≧15/hour, 30 obese [BMI>=27] \& 30 non-obese [BMI<27]) and 40 age-, gender-, BMI-matched controls without OSA. Venous blood 10 ml will be collected to isolate neutrophils, which are later tested for their ability to produce neutrophil extracellular traps (NETs) under the effect of PMA (phorbol 12-myristate 13-acetate).
Key inclusion criteria (2 listed)
- Adults with clinical diagnosis of moderate or severe OSA (AHI >=15/hour)
- Must be willing to participate in this study and sign permit
Key exclusion criteria (4 listed)
- Not willing to participate in this study
- Ever treated with continous positive airway pressure (CPAP) or other therapy for OSA
- Age < 20 years
- Have comorbid disease or condition, which could impact immunity (such as malignancy, chemotherapy, immune disease, diabetes etc)
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 |
|---|---|---|
| sleep apneaThis prospective observational study will enroll 60 moderate-to-severe OSA patients (AHI≧15/hour, 30 obese [BMI>=27] \& 30 non-obese [BMI<27]) and 40 age-, gender-, BMI-matched controls without OSA. Venous blood 10 ml will be collected to isolate neutrophils, which are later tested for their ability to produce neutrophil extracellular traps (NETs) under the effect of PMA (phorbol 12-myristate 13-acetate). | Other | Sleep apnea |
Primary outcome
ability to produce neutrophil extracellular traps (NETs)
Time frame: 0-90 dyas (if receive therapy)
Venous blood 10 ml will be collected to isolate neutrophils, which are later tested for their ability to produce neutrophil extracellular traps (NETs) under the effect of PMA (phorbol 12-myristate 13-acetate). The test will be repeated if OSA patients receive CPAP therapy (continous positive airway pressure therapy).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: Undecided
Related trials for OSA
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Apnea, Sleep Disorders
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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. This study is not recruiting at the moment.
Kun-Ta Chou, MD & Ph.D principal investigator
Taipei Veterans General Hospital, Taiwan
Questions about this trial
What is this clinical trial studying?
An observational study of OSA, run by Taipei Veterans General Hospital, 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun-Ta Chou, MD & Ph.D (+886922407055, ale1371@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ability to produce neutrophil extracellular traps (NETs) (time frame: 0-90 dyas (if receive therapy)). 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 7 Nov 2022.