Impact of Intermittent Hypoxia on Neutrophil Extracellular Traps

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).

Study Overview

• Status: Not yet recruiting
• Conditions: OSA
• Intervention / Treatment: Other: sleep apnea

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Kun-Ta Chou, MD & Ph.D; Phone Number: +886922407055; Email: ale1371@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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).

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sleep apnea; 60 moderate-to-severe OSA patients (AHI≧15/hour, 30 obese [BMI>=27] & 30 non-obese [BMI<27])	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).
Control; 40 age-, gender-, BMI-matched controls without OSA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: Ministry of Science and Technology, Taiwan
• Investigators: Principal Investigator: Kun-Ta Chou, MD & Ph.D, Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): July 31, 2025
• Study Completion (Anticipated): July 31, 2025

Study Registration Dates

• First Submitted: August 1, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; neutrophil extracellular traps; intermittent hypoxia
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: 2022-01-034AC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No