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Completed

NCT Number: NCT03070769

Inflammatory Markers in Obstructive Sleep Apnea (OSA) 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sleep Disorders Center, Department of Thoracic Medicine, University of Crete,

Heraklion, 71110, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Venous blood collection for biomarkers measurements

Procedure

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).

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Crete

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 6, 2017
Registry last updated
Mar 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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