Impact of Intermittent Hypoxia on Neutrophil Extracellular Traps

NCT05485688 | Unknown

• 1 other identifier: 2022-01-034AC
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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).

Conditions

OSA

Keywords

obstructive sleep apnea; intermittent hypoxia; neutrophil extracellular traps

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Sleep apnea

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

Other: sleep apnea

Control

40 age-, gender-, BMI-matched controls without OSA.

Interventions

sleep apnea 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).

Sleep apnea

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kun-Ta Chou, MD & Ph.D

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun-Ta Chou, MD & Ph.D

CONTACT

+886922407055; ale1371@yahoo.com.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 3, 2022
• Study Start: January 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: November 7, 2022

Record last verified: 2022-11