Sleep Apnea SyndromesNCT02342028
The Number and Function of Regular T Cell in Patients With Obstructive Sleep Apnea
An observational study of Sleep Apnea Syndromes, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- OSA
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: OSA patients free of other specific conditions affecting immunity are enrolled in this study.
Who may be able to join
- OSA patients diagnosed with a polysomnography
- Agree to participate the study and sign informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chest department, Taipei Veteran General Hospital
Taipei, Taiwan, 112
Kun-Ta Chou, MD, +886-2-28712121 ext. 2440, hbjoue@vghtpe.gov.tw
About this study
Official title: Impact of Intermittent Hypoxia on the Number and Function of Regular T Cell in Patients With Obstructive Sleep Apnea
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
Read the 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.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- OSA
- Keywords
- sleep apnea, intermittent hypoxia, regulatory T cell, autoimmunity
- Medical subject headings
- Sleep Apnea Syndromes, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSABiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: OSA | |
| Control | The control group enrolled age-, gender- and BMI-matched individuals without OSA, fulfilling the following requirements 1. 20~60 years ago, female or males 2. Agree participate the study and sign informed consent 3. No obvious comorbidities (including autoimmune diseases) 4. No history of sarcoidosis and tuberculosis 5. No use of steroid and immunosuppressant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and function of regular T cells in peripheral venous blood
Measured: 0-26 week
Secondary outcomes (1)
The number of Th12+ CD4+ cells
Measured: 0-26 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Kun-Ta Chou, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342028
- Sponsor's protocol ID
- 2015-01-005AC
- Status last verified
- Jan 2015
- First submitted
- 12 Jan 2015
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25331065Kotsianidis 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.
PubMed 19342412
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intermittent Hypoxia on the Number and Function of Regular T Cell in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02342028
- Acronym / sponsor ID
- 2015-01-005AC
- Conditions
- Sleep Apnea Syndromes
- Keywords
- sleep apnea, intermittent hypoxia, regulatory T cell, autoimmunity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA | – | Biological: OSAThe 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 |
| Control | – | –The control group enrolled age-, gender- and BMI-matched individuals without OSA, fulfilling the following requirements 1. 20~60 years ago, female or males 2. Agree participate the study and sign informed consent 3. No obvious comorbidities (including autoimmune diseases) 4. No history of sarcoidosis and tuberculosis 5. No use of steroid and immunosuppressant |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- OSA patients free of other specific conditions affecting immunity are enrolled in this study.
Key inclusion criteria (2 listed)
- OSA patients diagnosed with a polysomnography
- Agree to participate the study and sign informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OSAThis 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. | Biological | OSA |
Primary outcome
The number and function of regular T cells in peripheral venous blood
Time frame: 0-26 week
1 secondary outcome
The number of Th12+ CD4+ cells
Time frame: 0-26 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Background: PubMed 25331065Chou 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.
- Background: PubMed 19342412Kotsianidis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kun-Ta Chou, MD principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndromes, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun-Ta Chou, MD (+886-2-28712121 ext. 2440, hbjoue@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number and function of regular T cells in peripheral venous blood (time frame: 0-26 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02342028, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015.