Skip to main content
Clinical Trials/NCT04093102
NCT04093102
Unknown
Not Applicable

Role of Biomarkers to Screen for Obstructive Sleep Apnea

Assiut University0 sites90 target enrollmentOctober 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Assiut University
Enrollment
90
Primary Endpoint
Validity of biomarkers to screen for obstructive sleep apnea
Last Updated
6 years ago

Overview

Brief Summary

assess the relationship between obstructive sleep apnea and endocrine, inflammatory, and metabolic bio-markers in consecutively enrolled adult male patients with a clinical suspicion of obstructive sleep apnea.

Detailed Description

Obstructive sleep apnea (OSA) is a disorder with high prevalence, estimated to occur in 34% of men and 17% of women , afflicting more than 100 million adults worldwide. OSA is the third most common serious respiratory condition after Asthma and COPD. Patients with untreated OSA are at increased risk for hypertension, cardiovascular disease, heart failure, stroke, obesity, metabolic dysregulation, diabetes mellitus, daytime sleepiness, depression, accidents and are a significant burden on the healthcare system. Unfortunately, up to 90% of individuals with OSA remain without a diagnosis or therapy. The association between OSA and adverse health consequences has led the American Heart Association and others to suggest that OSA screening be integrated into routine clinical care. Current tools for OSA screening rely on questionnaires with low diagnostic accuracy from low-quality studies, as reported in meta-analyses, OSA screening measures that are frequently used include the Epworth Sleepiness Scale (ESS) and STOP-Bang questionnaires. The ESS assesses subjective daytime sleepiness but is nonspecific for OSA, was not designed nor validated for OSA screening. The recent American Academy of Sleep Medicine (AASM) clinical practice guidelines report that more accurate and user-friendly screening tools, such as blood bio-markers, are needed to better predict OSA diagnosis and severity, a recent review of potential OSA bio-markers concludes that an optimal screening test should be clinically sensitive, specific, simple, timely, inexpensive, and correlate to disease severity. Furthermore, bio-markers should make pathophysiological sense, reflecting functional changes that accompany OSA. Numerous individual OSA blood bio-markers have been studied previously dysfunctions in metabolic and endocrine systems induced by OSA, chronic inflammation, hypoxemia, sleep fragmentation, and stress are associated with alterations in bio-markers. These bio-markers include glycated hemoglobin (HbA1c), C-reactive protein (CRP), erythropoietin (EPO), and uric acid,Unfortunately, the diagnostic utility of individual bio-markers or combinations of markers is inconclusive in identifying OSA.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
October 2022
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ali Abuzaid Ali

Principal Investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

  • All patients with a clinical suspicion of obstructive sleep apnea enrolled to the investigator's chest department.

Exclusion Criteria

  • Patients who previously treated as obstructive sleep apnea, or receiving opioid pain medications.

Outcomes

Primary Outcomes

Validity of biomarkers to screen for obstructive sleep apnea

Time Frame: baseline

analysis of biomarkers results (which include Pentraxin 3, HbA1C,Uric acid,CRP,ESR,Plasma fibrinogen) will be assessed and compared to the results of polysymnography

Secondary Outcomes

  • Inflammatory biomarker level in OSA patients compared to controls(baseline)

Similar Trials