Impact of Intermittent Hypoxia on Neutrophil Extracellular Traps

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05485688
Collaborator
Ministry of Science and Technology, Taiwan (Other)
100
36

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Impact of Intermittent Hypoxia on Neutrophil Extracellular Traps
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jul 31, 2025
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. ability to produce neutrophil extracellular traps (NETs) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Taipei Veterans General Hospital, Taiwan
  • Ministry of Science and Technology, Taiwan

Investigators

  • Principal Investigator: Kun-Ta Chou, MD & Ph.D, Taipei Veterans General Hospital, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT05485688
Other Study ID Numbers:
  • 2022-01-034AC
First Posted:
Aug 3, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Taipei Veterans General Hospital, Taiwan
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022