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

Sleep Apnea Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02342028
• Other study ID #: 2015-01-005AC
• Status: Recruiting
• Phase: N/A
• First received: January 12, 2015
• Last updated: January 23, 2015
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2015
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Kun-Ta Chou, MD
• Phone: +886-2-28712121
• Email: hbjoue[@]vghtpe.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

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, 

References & Publications (2)

Chou KT, Liu CC, Hsu HS, Chang SC, Chen YM, Perng DW, Hsu YT, Lee YC, Hung SC. Nocturnal stem cell mobilization in patients with obstructive sleep apnoea: a pilot study. Eur J Clin Invest. 2014 Dec;44(12):1189-96. doi: 10.1111/eci.12353. — View Citation

Kotsianidis I, Nakou E, Bouchliou I, Tzouvelekis A, Spanoudakis E, Steiropoulos P, Sotiriou I, Aidinis V, Margaritis D, Tsatalas C, Bouros D. Global impairment of CD4+CD25+FOXP3+ regulatory T cells in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2009 Jun 15;179(12):1121-30. doi: 10.1164/rccm.200812-1936OC. Epub 2009 Apr 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number and function of regular T cells in peripheral venous blood		0-26 week	No
Secondary	The number of Th12+ CD4+ cells		0-26 week	No