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Inflammatory Markers in Obstructive Sleep Apnea (OSA) Patients.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03070769
Recruitment Status : Completed
First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Izolde Bouloukaki, University of Crete

Brief Summary:

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.


Condition or disease Intervention/treatment
Obstructive Sleep Apnea of Adult Procedure: Venous blood collection for biomarkers measurements

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.

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Study Type : Observational
Actual Enrollment : 1053 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Evaluation of Inflammatory Markers in a Large Sample of Obstructive Sleep Apnea Patients
Actual Study Start Date : June 1, 2012
Actual Primary Completion Date : June 1, 2016
Actual Study Completion Date : December 12, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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).




Primary Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070769


Locations
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Greece
Sleep Disorders Center, Department of Thoracic Medicine, University of Crete,
Heraklion, Greece, 71110
Sponsors and Collaborators
University of Crete
Investigators
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Study Chair: Sophia Schiza, MD, PhD University of Crete
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Izolde Bouloukaki, Principal Investigator, University of Crete
ClinicalTrials.gov Identifier: NCT03070769    
Other Study ID Numbers: OSAINFL1
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases