Role of Biomarkers to Screen for Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Role of Biomarkers to Screen for Obstructive Sleep Apnea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04093102
• Other study ID #: obstructive sleep apnea
• Status: Not yet recruiting
• Start date: October 1, 2019
• Est. completion date: October 2022

Study information

• Verified date: September 2019
• Source: Assiut University
• Contact: Abuzaid
• Phone: 01064756136
• Email: anaover32[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validity of biomarkers to screen for obstructive sleep apnea	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	Inflammatory biomarker level in OSA patients compared to controls	Inflammatory biomarkers which include ESR , CRP and pentraxin 3 will be measured and compared in both cases and controls.	baseline