Inflammatory Markers in Obstructive Sleep Apnea (OSA) Patients.

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03070769
• Other study ID #: OSAINFL1
• Status: Completed
• Phase: N/A
• First received: February 24, 2017
• Last updated: March 3, 2017
• Start date: June 1, 2012
• Est. completion date: December 12, 2016

Study information

• Verified date: March 2017
• Source: University of Crete
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1053
• Est. completion date: December 12, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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,

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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).

Locations

Country	Name	City	State
Greece	Sleep Disorders Center, Department of Thoracic Medicine, University of Crete,	Heraklion

Sponsors (1)

Lead Sponsor	Collaborator
University of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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