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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02272608
Other study ID # Ordu University
Secondary ID
Status Completed
Phase N/A
First received October 12, 2014
Last updated October 21, 2014
Start date November 2012
Est. completion date August 2014

Study information

Verified date October 2014
Source T.C. ORDU ÜNIVERSITESI
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health (Saglik Bakanligi Ilaç ve Tibbi Cihaz Kurumu)
Study type Observational

Clinical Trial Summary

There is some evidence suggesting that OSA is associated with low level of systemic inflammation and oxidative stress. Low level systemic inflammation and subsequent vascular damage has been implicated as the underlying mechanism responsible for comorbidities. Detection of altered inflammatory markers in OSAS patients may predict the degree of nocturnal sleep disturbance and associated systemic inflammation and presence of comorbidities. Recently, novel inflammatory biomarkers, such as neutrophil to lymphocyte ratio (NLR) have been proposed as an indicator of systemic inflammation. To our knowledge, NLR has not been studied in OSAS. We conducted the present study to evaluate the association between OSAS and inflammatory markers CRP, ESR and NLR.


Recruitment information / eligibility

Status Completed
Enrollment 279
Est. completion date August 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: Subjects who were referred for polysomnography (PSG) testing and performed the test were included Exclusion Criteria: Patients with malignancy, diabetes mellitus, dyslipidemia, cardiovascular disease or hypertension, chronic inflammatory processes, thyroid dysfunction, chronic hepatic disease, renal failure, any acute- subacute infectious disease within past 2 months, if data are incomplete such as blood sample testing results, if they were unable to perform complete PSG testing.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Intervention

Other:
Evaluation of Sleep Apnea Related Inflammation with CRP, ESR and Neutrophil toLymphocyte Ratio
CRP, ESR and Neutrophil toLymphocyte Ratio values of sleep apnea patients were evaluated with respect to apnea- hypopnea scores.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
T.C. ORDU ÜNIVERSITESI

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of systemic inflammatory markers C-Reactive Protein, Erythrocyte Sedimentation Ratio and neutrophil to lymphocyte ratio in sleep apnea patients After withdrawal of serum samples, patients were taken to sleep lab at the same day and polysomnography reports were evaluated 24 hours later Yes
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