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Impact of Intermittent Hypoxia on the Function of the Phagocytes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03618719
Recruitment Status : Unknown
Verified March 2019 by Taipei Veterans General Hospital, Taiwan.
Recruitment status was:  Recruiting
First Posted : August 7, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Study Description
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Brief Summary:
Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis are included as well as healthy controls without OSA. 15 cc peripheral venous blood is drawn on the date of diagnosis of OSA and 3-6 months after CPAP therapy. Granulocytes are harvested and tested for its function, such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.

Condition or disease
Obstructive Sleep Apnea of Adult

Detailed Description:
Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis are included. Healthy controls without OSA are enrolled, too. 15 cc peripheral venous blood is drawn on the date of diagnosis of OSA and 3-6 months after CPAP therapy (not given to controls). Granulocytes are harvested and tested for its function, such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.
Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Intermittent Hypoxia on Phagocytosis and Sepsis Outcomes: the Potential Role of Statin (Part III: Human Study in 2018-2019)
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : July 3, 2019
Estimated Study Completion Date : July 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Groups and Cohorts
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Group/Cohort
Obstructive sleep apnea
Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis
Control
Healthy controls without OSA


Outcome Measures
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Primary Outcome Measures :
  1. Granuolocyte function [ Time Frame: On enrollment ]
    Granuolocyte function, such as such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.

  2. Granuolocyte function [ Time Frame: 3-month ]
    Granuolocyte function, such as such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.

  3. Granuolocyte function [ Time Frame: 6-month ]
    Granuolocyte function, such as such as phagocytosis, reactive oxygen species (ROS)


Biospecimen Retention:   Samples With DNA
white cells in peripheral venous blood

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

<OSA group> Adult Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis are included.

<Control group> Healthy adult controls without OSA

Criteria

Inclusion Criteria:

<OSA group> 1. Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis 2. aged 20 years or older 3. Apnea-hypopnea index (AHI) at least 15/hour 4. Willing to participate this study <Control group>

  1. Healthy controls without OSA
  2. aged 20 years or older
  3. AHI less than 5/hour

Exclusion Criteria:

<OSA group>

  1. OSA patients who do not need continuous positive airway pressure (CPAP) therapy
  2. OSA Patients have ever received CPAP or other treatment
  3. aged less than 20 years
  4. AHI at least 15/hour
  5. Not willing to participate this study <Control group>

1. Apnea-hypopnea index (AHI) equals to or more than 5/hour 2. aged less than 20 years 3. Not willing to participate this study

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03618719


Contacts
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Contact: Kun-Ta Chou, M.D +886922407055 ale1371@yahoo.com.tw

Locations
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Taiwan
Chest department, Taipei Veteran General Hospital Recruiting
Taipei City, Taiwan, 112
Contact: Kun-Ta Chou, MD    +886-2-28712121 ext 3085    hbjoue@vghtpe.gov.tw   
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Kun-Ta Chou, M.D Taipei Veterans General Hospital, Taiwan
More Information
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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03618719    
Other Study ID Numbers: 2016-06-005CC
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

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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:
obstructive sleep apnea
intermittent hypoxia
granulocyte function
continuous positive airway pressure (CPAP) therapy
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Hypoxia
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory