Impact of Intermittent Hypoxia on the Function of the Phagocytes

NCT03618719 | Unknown

• 1 other identifier: 2016-06-005CC
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea of Adult

Keywords

obstructive sleep apnea; intermittent hypoxia; granulocyte function; continuous positive airway pressure (CPAP) therapy

Outcome Measures

Primary Outcomes (3)

• Granuolocyte function

  Granuolocyte function, such as such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.

  On enrollment

• Granuolocyte function

  Granuolocyte function, such as such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.

  3-month

• Granuolocyte function

  Granuolocyte function, such as such as phagocytosis, reactive oxygen species (ROS)

  6-month

Study Arms (2)

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

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

\<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

You may qualify if:

• \<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\>
• Healthy controls without OSA
• aged 20 years or older
• AHI less than 5/hour

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Chest department, Taipei Veteran General Hospital

Taipei, 112, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

white cells in peripheral venous blood

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Microcephaly, Primary Autosomal Recessive, 6

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, M.D

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun-Ta Chou, M.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 2, 2018
• First Posted: August 7, 2018
• Study Start: March 5, 2019
• Primary Completion: July 3, 2019
• Study Completion: July 3, 2019
• Last Updated: March 12, 2019

Record last verified: 2019-03

Locations

TW (1)