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

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Unknown status

CT.gov ID

NCT02342028

Collaborator

(none)

Enrollment

Location

Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea Syndromes	Biological: OSA

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 Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Impact of Intermittent Hypoxia on the Number and Function of Regular T Cell in Patients With Obstructive Sleep Apnea

Study Start Date :

Jan 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
OSA The study group enrolled patients with OSA, fulfilling the following requirements 20~60 years ago, female or males Agree participate the study and sign informed consent Has not received any treatment for OSA No obvious comorbidities (including autoimmune diseases) No history of sarcoidosis and tuberculosis No use of steroid and immunosuppressant	Biological: OSA This study aims to compare the difference in the number and function of regulatory T cells between OSA patients and controls. The investigators will draw peripheral venous blood samples from both groups and measure the number and function of their regulatory T cells. However, some, NOT ALL, of OSA patients may receive continuous positive airway pressure (CPAP) treatment-the standard therapy for severe-to-moderate OSA. Use of CPAP is based on physician's suggestion and patients' decision, but not for this study. The devices are provided by patients themselves and its type/brand is not limited or prespecified. For those with CPAP therapy, their blood sample will be re-collected 26 weeks later to repeat measurement for subgroup analysis.
Control The control group enrolled age-, gender- and BMI-matched individuals without OSA, fulfilling the following requirements 20~60 years ago, female or males Agree participate the study and sign informed consent No obvious comorbidities (including autoimmune diseases) No history of sarcoidosis and tuberculosis No use of steroid and immunosuppressant

Arm

Intervention/Treatment

OSA

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

Biological: OSA

This study aims to compare the difference in the number and function of regulatory T cells between OSA patients and controls. The investigators will draw peripheral venous blood samples from both groups and measure the number and function of their regulatory T cells. However, some, NOT ALL, of OSA patients may receive continuous positive airway pressure (CPAP) treatment-the standard therapy for severe-to-moderate OSA. Use of CPAP is based on physician's suggestion and patients' decision, but not for this study. The devices are provided by patients themselves and its type/brand is not limited or prespecified. For those with CPAP therapy, their blood sample will be re-collected 26 weeks later to repeat measurement for subgroup analysis.

Control

The control group enrolled age-, gender- and BMI-matched individuals without OSA, fulfilling the following requirements 20~60 years ago, female or males Agree participate the study and sign informed consent No obvious comorbidities (including autoimmune diseases) No history of sarcoidosis and tuberculosis No use of steroid and immunosuppressant

Outcome Measures

Primary Outcome Measures

The number and function of regular T cells in peripheral venous blood [0-26 week]

Secondary Outcome Measures

The number of Th12+ CD4+ cells [0-26 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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