Inflammatory Markers in Obstructive Sleep Apnea (OSA) Patients.

NCT ID: NCT03070769

Last Updated: 2017-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1053 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-01
• Study Completion Date: 2016-12-12

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.

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.

Conditions

Obstructive Sleep Apnea of Adult

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Control

Subjects without Obstructive sleep apnea (Apnea-hypopnea index-AHI\<5). Venous blood collection for biomarkers measurements.

Venous blood collection for biomarkers measurements

Intervention Type: 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).

Obstructive sleep apnea (OSA) patients

Patients with Obstructive sleep apnea (AHI\> or =5). Venous blood collection for biomarkers measurements.

Venous blood collection for biomarkers measurements

Intervention Type: 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).

Interventions

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).

Intervention Type: PROCEDURE

Eligibility 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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Crete

OTHER

Sponsor Role: lead

Responsible Party

Izolde Bouloukaki

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sophia Schiza, MD, PhD

Role: STUDY_CHAIR

University of Crete

Locations

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

Heraklion, , Greece

Countries

Greece

References

Bouloukaki I, Mermigkis C, Tzanakis N, Kallergis E, Moniaki V, Mauroudi E, Schiza SE. Evaluation of Inflammatory Markers in a Large Sample of Obstructive Sleep Apnea Patients without Comorbidities. Mediators Inflamm. 2017;2017:4573756. doi: 10.1155/2017/4573756. Epub 2017 Jul 31.

Reference Type: DERIVED

PMID: 28831208 (View on PubMed)

Other Identifiers

OSAINFL1

Identifier Type: -

Identifier Source: org_study_id