Inflammatory Markers in Obstructive Sleep Apnea (OSA) Patients.

March 3, 2017 updated by: Izolde Bouloukaki, University of Crete

Evaluation of Inflammatory Markers in a Large Sample of Obstructive Sleep Apnea Patients

The aim of our study was to assess the levels of inflammatory biomarkers in a large sample of OSA patients and to investigate any correlation between these markers with clinical and polysomnographic (PSG) parameters.

Subjects undergone a PSG for OSA diagnosis were recruited. Patients with known comorbidities were excluded from the study. Included patients were grouped according to apnea-hypopnea index (AHI) as mild, moderate and severe. Patients with AHI < 5 served as control group. Demographic, PSG data, serum levels of hs-C-reactive protein (hs-CRP), fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) were measured and compared between groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Systemic inflammation is important in obstructive sleep apnea (OSA) pathophysiology and its comorbidity. The objective of this study was to investigate how early biomarkers of inflammation may be altered in OSA patients. To complete this goal the investigators assessed the circulating levels of four inflammatory markers, hs-C-reactive protein (hs-CRP), Fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) in a representative population of consecutively enrolled, untreated and otherwise healthy subjects with a clinical suspicion of obstructive sleep apnea. A secondary objective was to investigate any correlation between these markers with clinical and polysomnographic (PSG) parameters of these subjects.Subjects who had undergone a PSG for OSA diagnosis were recruited. Patients with known comorbidities were excluded from the study. Included patients were grouped according to apnea-hypopnea index (AHI) as mild, moderate and severe. Patients with AHI < 5 served as control group. Demographic, PSG data, serum levels of hs-CRP, fibrinogen, ESR and UA were measured and compared between groups.

Study Type

Observational

Enrollment (Actual)

1053

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Heraklion, Greece, 71110
        • Sleep Disorders Center, Department of Thoracic Medicine, University of Crete,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive patients, who were admitted to the Sleep Disorders Center, Department of Thoracic Medicine, University of Crete Medical School, for evaluation of suspected sleep-disordered breathing, were considered as potential recruits for this study.

Description

Inclusion Criteria:

  • newly diagnosed, untreated, and otherwise healthy obstructive sleep apnea (OSA) patients
  • healthy subjects (without OSA)

Exclusion Criteria:

  • refusal to participate,
  • previous OSA diagnosis and treatment
  • known comorbidities,
  • pregnancy,
  • history of narcolepsy or restless leg syndrome.
  • Subjects younger than 18 years,
  • Central sleep apnea syndrome (CSAS) diagnosed with PSG,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Subjects without Obstructive sleep apnea (Apnea-hypopnea index-AHI<5). Venous blood collection for biomarkers measurements.
Procedure: Venous blood collection for biomarkers measurements
Venous blood was collected in all subjects for measurements of hs-C-reactive protein (hs-CRP), fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) between 8:00 and 9:00 AM, following an overnight fast, shortly after the conclusion of the overnight polysomnography (PSG).
Obstructive sleep apnea (OSA) patients
Patients with Obstructive sleep apnea (AHI> or =5). Venous blood collection for biomarkers measurements.
Procedure: Venous blood collection for biomarkers measurements
Venous blood was collected in all subjects for measurements of hs-C-reactive protein (hs-CRP), fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) between 8:00 and 9:00 AM, following an overnight fast, shortly after the conclusion of the overnight polysomnography (PSG).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory biomarkers levels in OSA patients without comorbidities compared to controls.
Time Frame: 4 years
Inflammatory biomarkers levels in OSA patients without comorbidities compared to controls,as assessed by high sensitive -C-reactive protein (hs-CRP), Fibrinogen, Erythrocyte sedimentation rate (ESR) and uric acid (UA).
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Crete

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2012

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

December 12, 2016

Study Registration Dates

First Submitted

February 24, 2017

First Submitted That Met QC Criteria

March 3, 2017

First Posted (Actual)

March 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

March 3, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSAINFL1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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