Clinical trial NCT05485688: Impact of Intermittent Hypoxia on Neutrophil Extracellular Traps
Official title: Impact of Intermittent Hypoxia on Neutrophil Extracellular Traps
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: OSA
Keywords: obstructive sleep apnea
intermittent hypoxia
neutrophil extracellular traps
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2022-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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. 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).

Eligibility criteria: Inclusion Criteria

* Adults with clinical diagnosis of moderate or severe OSA (AHI \>=15/hour)
* Must be willing to participate in this study and sign permit

Exclusion Criteria

* 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)

Primary outcomes:
measure: ability to produce neutrophil extracellular traps (NETs)
timeFrame: 0-90 dyas (if receive therapy)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Kun-Ta Chou, MD & Ph.D
role: PRINCIPAL_INVESTIGATOR
References: