Clinical trial NCT02342028: The Number and Function of Regular T Cell in Patients With Obstructive Sleep Apnea
Official title: Impact of Intermittent Hypoxia on the Number and Function of Regular T Cell in Patients With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea Syndromes
Keywords: sleep apnea
intermittent hypoxia
regulatory T cell
autoimmunity
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2015-01-19
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: OSA patients free of other specific conditions affecting immunity are enrolled in this study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The number and function of regular T cells in peripheral venous blood
timeFrame: 0-26 week
Secondary outcomes:
measure: The number of Th12+ CD4+ cells
timeFrame: 0-26 week
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, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.