Role of Biomarkers to Screen for Obstructive Sleep Apnea
NCT ID: NCT04093102
Last Updated: 2019-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
90 participants
OBSERVATIONAL
2019-10-01
2022-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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cases
cases with obsrtuctive sleep apnea
biomarkers
bio-markers testing will be made to all suspected OSA patients(CRP, Hba1C,uric acid, ESR, plasma fibrinogen, pentraxin3), and to control cases.
control
cases without obstructive sleep apnea.
biomarkers
bio-markers testing will be made to all suspected OSA patients(CRP, Hba1C,uric acid, ESR, plasma fibrinogen, pentraxin3), and to control cases.
Interventions
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biomarkers
bio-markers testing will be made to all suspected OSA patients(CRP, Hba1C,uric acid, ESR, plasma fibrinogen, pentraxin3), and to control cases.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ali Abuzaid Ali
Principal Investigator
Principal Investigators
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suzan salama, professor
Role: STUDY_DIRECTOR
Central Contacts
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References
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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.
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. doi: 10.1093/sleep/22.6.749.
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.
Montesi SB, Bajwa EK, Malhotra A. Biomarkers of sleep apnea. Chest. 2012 Jul;142(1):239-245. doi: 10.1378/chest.11-2322.
Other Identifiers
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obstructive sleep apnea
Identifier Type: -
Identifier Source: org_study_id
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