Impact of Intermittent Hypoxia on Neutrophil Extracellular Traps

NCT ID: NCT05485688

Last Updated: 2022-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-31

Study Completion Date

2025-07-31

Brief Summary

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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

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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

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OSA

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Sleep apnea

60 moderate-to-severe OSA patients (AHI≧15/hour, 30 obese \[BMI\>=27\] \& 30 non-obese \[BMI\<27\])

sleep apnea

Intervention Type OTHER

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.

No interventions assigned to this group

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role collaborator

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kun-Ta Chou, MD & Ph.D

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Central Contacts

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Kun-Ta Chou, MD & Ph.D

Role: CONTACT

+886922407055

Other Identifiers

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2022-01-034AC

Identifier Type: -

Identifier Source: org_study_id

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