Role of Biomarkers to Screen for Obstructive Sleep Apnea
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
cases
cases with obsrtuctive sleep apnea
|
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.
|
bio-markers testing will be made to all suspected OSA patients(CRP, Hba1C,uric acid, ESR, plasma fibrinogen, pentraxin3), and to control cases.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: suzan salama, professor
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Obstructive Sleep Apnea
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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