Skip to content

Role of Biomarkers to Screen for Obstructive Sleep Apnea

Role of Biomarkers to Screen for Obstructive Sleep Apnea

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04093102
Enrollment
90
Registered
2019-09-17
Start date
2019-10-01
Completion date
2022-10-31
Last updated
2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Brief 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.

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_TESTbiomarkers

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

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.

Design outcomes

Primary

MeasureTime frameDescription
Validity of biomarkers to screen for obstructive sleep apneabaselineanalysis 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

MeasureTime frameDescription
Inflammatory biomarker level in OSA patients compared to controlsbaselineInflammatory biomarkers which include ESR , CRP and pentraxin 3 will be measured and compared in both cases and controls.

Contacts

Primary ContactAbuzaid
anaover32@yahoo.com01064756136
Backup Contactdoaa magdy, lecturer
doaa_magy2020@yahoo.com01006261010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026