NCT02342028

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

January 12, 2015

Last Update Submit

January 23, 2015

Conditions

Sleep Apnea Syndromes

Keywords

sleep apneaintermittent hypoxiaregulatory T cellautoimmunity

Outcome Measures

Primary Outcomes (1)

  • The number and function of regular T cells in peripheral venous blood

    0-26 week

Secondary Outcomes (1)

  • The number of Th12+ CD4+ cells

    0-26 week

Study Arms (2)

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

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

Interventions

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.

OSA

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

OSA patients free of other specific conditions affecting immunity are enrolled in this study.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chest department, Taipei Veteran General Hospital

Taipei, Taiwan, 112, Taiwan

RECRUITING

Related 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.

    PMID: 25331065BACKGROUND

  • 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.

    PMID: 19342412BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

the whole blood of enrollees

MeSH Terms

Conditions

Sleep Apnea SyndromesAutoimmune Diseases

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesImmune System Diseases

Study Officials

  • Kun-Ta Chou, MD

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun-Ta Chou, MD

CONTACT

+886-2-28712121hbjoue@vghtpe.gov.tw

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chou, Kun-Ta

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 19, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations

TW(1)