Role of Biomarkers to Screen for Obstructive Sleep Apnea

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2022

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.

Interventions

  • Diagnostic Test: biomarkers
    • bio-markers testing will be made to all suspected OSA patients(CRP, Hba1C,uric acid, ESR, plasma fibrinogen, pentraxin3), and to control cases.

Arms, Groups and Cohorts

  • cases
    • cases with obsrtuctive sleep apnea
  • control
    • cases without obstructive sleep apnea.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Inflammatory biomarker level in OSA patients compared to controls
    • Time Frame: baseline
    • Inflammatory biomarkers which include ESR , CRP and pentraxin 3 will be measured and compared in both cases and controls.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ali Abuzaid Ali, Principal Investigator – Assiut University
  • Overall Official(s)
    • suzan salama, professor, Study Director,
  • Overall Contact(s)
    • Abuzaid, 01064756136, anaover32@yahoo.com

References

Watson NF. Health Care Savings: The Economic Value of Diagnostic and Therapeutic Care for Obstructive Sleep Apnea. J Clin Sleep Med. 2016 Aug 15;12(8):1075-7. doi: 10.5664/jcsm.6034. Review.

Kapur V, Blough DK, Sandblom RE, Hert R, de Maine JB, Sullivan SD, Psaty BM. The medical cost of undiagnosed sleep apnea. Sleep. 1999 Sep 15;22(6):749-55.

Maeder MT, Mueller C, Schoch OD, Ammann P, Rickli H. Biomarkers of cardiovascular stress in obstructive sleep apnea. Clin Chim Acta. 2016 Sep 1;460:152-63. doi: 10.1016/j.cca.2016.06.046. Epub 2016 Jul 2. Review.

Montesi SB, Bajwa EK, Malhotra A. Biomarkers of sleep apnea. Chest. 2012 Jul;142(1):239-245. doi: 10.1378/chest.11-2322. Review.

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