Inflammatory Markers in Obstructive Sleep Apnea (OSA) Patients.

NCT03070769 | Completed

• 1 other identifier: OSAINFL1
• Study Type: observational
• Target: 1,053
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

• Inflammatory biomarkers levels in OSA patients without comorbidities compared to controls.

  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

Study Arms (2)

Control

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

Procedure: Venous blood collection for biomarkers measurements

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

Interventions

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).

Control; Obstructive sleep apnea (OSA) patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Crete: lead

Study Sites (1)

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

Heraklion, 71110, Greece

Location

Related Publications (1)

• 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.

  PMID: 28831208 DERIVED

Study Officials

• Sophia Schiza, MD, PhD

  University of Crete

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 6, 2017
• Study Start: June 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: December 12, 2016
• Last Updated: March 6, 2017

Record last verified: 2017-03

Locations

GR (1)