Impact of Intermittent Hypoxia on Neutrophil Extracellular Traps

OSA Clinical Trial

Official title:

Impact of Intermittent Hypoxia on Neutrophil Extracellular Traps

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05485688
• Other study ID #: 2022-01-034AC
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: November 2022
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Kun-Ta Chou, MD & Ph.D
• Phone: +886922407055
• Email: ale1371[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hypoxia
• OSA

Intervention

Other:
• sleep apnea
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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	Ministry of Science and Technology, Taiwan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	0-90 dyas (if receive therapy)