Clinical trial NCT03618719: Impact of Intermittent Hypoxia on the Function of the Phagocytes
Official title: Impact of Intermittent Hypoxia on Phagocytosis and Sepsis Outcomes: the Potential Role of Statin (Part III: Human Study in 2018-2019)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea of Adult
Keywords: obstructive sleep apnea
intermittent hypoxia
granulocyte function
continuous positive airway pressure (CPAP) therapy
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2018-08-07
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Granuolocyte function
timeFrame: On enrollment
measure: Granuolocyte function
timeFrame: 3-month
measure: Granuolocyte function
timeFrame: 6-month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Chest department, Taipei Veteran General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Kun-Ta Chou, M.D
role: PRINCIPAL_INVESTIGATOR
References: