The Number and Function of Regular T Cell in Patients With Obstructive Sleep Apnea

• Conditions: Sleep Apnea Syndromes
• Interventions: Biological: OSA

• Registration Number: NCT02342028
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

To compare the number and function of regular T cell of patients with obstructive sleep apnea (OSA) versus that of age-, gender- and BMI (body mass index)-matched controls

Detailed Description

Patients with obstructive sleep apnea (OSA) experience intermittent hypoxemia and arousal during sleep due to recurrent collapse of upper airway. Epidemiologic evidence showed they were at higher risk for autoimmune diseases. The regular T cell (Treg) has a crucial role in controlling autoimmunity. In this study, 40 OSA patients and 40 age-, gender- and BMI-matched controls will be recruited. Peripheral venous blood of the participants is drawn for numeration of CD4+CD25+FoxP3+ regular T cells by flow cytometry. As well, the CD4+CD25+ regular T cells are enriched by MACS and tested for their suppressive functions on proliferation assays. Th12+ CD4+ cells are also measured.

Study Timeline

• Status Verified: 2015-01
• Study Start: 2015-01
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-19
• Last Update Submitted: 2015-01-23
• Last Update Posted: 2015-01-26
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. OSA patients diagnosed with a polysomnography
2. Agree to participate the study and sign informed consent

Exclusion Criteria

1. Do not agree to participate the study and sign informed consent
2. Has received any treatment or OSA
3. With major comorbidities (such as a diabetes, heart disease, lung diseases, renal diseases, autoimmune diseases, but hypertension excluded)
4. History of sarcoidosis and tuberculosis
5. On treatment of steroid and immunosuppressant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OSA	OSA	The study group enrolled patients with OSA, fulfilling the following requirements 1. 20\~60 years ago, female or males 2. Agree participate the study and sign informed consent 3. Has not received any treatment for OSA 4. No obvious comorbidities (including autoimmune diseases) 5. No history of sarcoidosis and tuberculosis 6. No use of steroid and immunosuppressant

Primary Outcome Measures

Name	Time	Method
The number and function of regular T cells in peripheral venous blood	0-26 week

Secondary Outcome Measures

Name	Time	Method
The number of Th12+ CD4+ cells	0-26 week

Trial Locations

Locations (1)

Chest department, Taipei Veteran General Hospital; 🇨🇳 Taipei City, Taiwan