The Association Between Obstructive Sleep Apnea Severity and Red Blood Cells Indices
1 other identifier
observational
30
1 country
1
Brief Summary
Obstructive sleep apnea syndrome (OSAS) is characterized by recurrent episodes of obstructive events (apnea and hypopnea) and intermittent hypoxia, which in turn contributes to the systemic inflammation that underlies this disease and its consequences (Ryan et al 2009, Gileles-Hillel et al 2014). This systemic inflammation leads to endothelial dysfunction, which contributes to the pathogenesis of cardiovascular complications in OSAS, in addition to the exposure to risk factors, such as male gender, older age, obesity, and lack of exercise (Lorenzi Filho et al 2010). Some red blood cells (RBC) and platelets indices have emerged as inflammatory biomarkers in various diseases (Tertemiz et al 2016) The severity of OSA is significantly associated with increase hematocrit, even after controlling for possible confounding variables. However, nocturnal hypoxemia in OSA does not usually lead to clinical polycythemia (Choi et al 2006). In patients referred with a clinical diagnosis of OSAS, RDW may be a marker for the severity of the condition. As RDW is usually included in a complete blood count, it could provide an inexpensive tool for triaging OSAS patients for polysomnography evaluation (Sökücü et al 2012). The hematological indices white blood cell count (WBC), neutrophil count, lymphocyte count, mean platelet volume (MPV), platelet distribution width (PDW), and red blood cell distribution width (RDW) have been proposed as alternative markers to those normally used clinically, e.g., interleukin-6 (IL6) and C-reactive protein, to evaluate the burden of inflammation in OSAS (Wu et al 2018)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2023
Shorter than P25 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2023
CompletedFirst Submitted
Initial submission to the registry
February 10, 2024
CompletedFirst Posted
Study publicly available on registry
February 20, 2024
CompletedFebruary 20, 2024
February 1, 2024
7 months
February 10, 2024
February 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Red Blood Cells Indices
Red Blood Cells Indices
one night
Interventions
morning after the night of monitored sleep by PSG. With stress on red blood cell indices (RBC count, MCV, MCH, RDW)
Eligibility Criteria
a thirty (30) patients with suspected obstructive sleep apnea (OSA)
You may qualify if:
- \. Age above 18 years. 2. Stable patient with suspected OSA
You may not qualify if:
- \. Age \<18 years. 2. Pregnant females 3. Hemodynamically unstable patients 4. Patient with Chronic diseases like COPD, CHF, CKD, CLD. DM and Stroke 5. Patient with hematologic malignancies 6. Patient on anticoagulants 7. Patients with recent blood transfusion 8. Patient with psychosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tamer Awad Elsayed
Al Mansurah, Dakhlia, 050, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 10, 2024
First Posted
February 20, 2024
Study Start
March 20, 2023
Primary Completion
October 20, 2023
Study Completion
December 20, 2023
Last Updated
February 20, 2024
Record last verified: 2024-02