Clinical trial NCT03070769: Inflammatory Markers in Obstructive Sleep Apnea (OSA) Patients.
Official title: Evaluation of Inflammatory Markers in a Large Sample of Obstructive Sleep Apnea Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: University of Crete
Sponsor class: OTHER
First posted: 2017-03-06
Enrollment: 1053
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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,

Primary outcomes:
measure: Inflammatory biomarkers levels in OSA patients without comorbidities compared to controls.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: Sleep Disorders Center, Department of Thoracic Medicine, University of Crete,
Study officials:
affiliation: University of Crete
name: Sophia Schiza, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.