Role of Biomarkers to Screen for Obstructive Sleep Apnea

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04093102
Study type	Observational
Source	Assiut University
Contact	Abuzaid
Phone	01064756136
Email	anaover32@yahoo.com
Status	Not yet recruiting
Phase
Start date	October 1, 2019
Completion date	October 2022

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.