Impact of Intermittent Hypoxia on the Function of the Phagocytes

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

Impact of Intermittent Hypoxia on Phagocytosis and Sepsis Outcomes: the Potential Role of Statin (Part III: Human Study in 2018-2019)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03618719
• Other study ID #: 2016-06-005CC
• Status: Recruiting
• Start date: March 5, 2019
• Est. completion date: July 3, 2019

Study information

• Verified date: March 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Kun-Ta Chou, M.D
• Phone: +886922407055
• Email: ale1371[@]yahoo.com.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 3, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Taiwan	Chest department, Taipei Veteran General Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Granuolocyte function	Granuolocyte function, such as such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.	On enrollment
Primary	Granuolocyte function	Granuolocyte function, such as such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.	3-month
Primary	Granuolocyte function	Granuolocyte function, such as such as phagocytosis, reactive oxygen species (ROS)	6-month