- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06265129
The Association Between Obstructive Sleep Apnea Severity and Red Blood Cells Indices
Study Overview
Status
Conditions
Detailed Description
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)
Aim of Work:
To study the relationship between severity of obstructive sleep apnea and red blood cell indices
Study Design:
Retrospective Cross-sectional study
Patients and methods:
This cross-sectional study will be conducted at Chest Medicine Department, Sleep Disordered Breathing Unit, Mansoura university hospital on a thirty (30) patients with suspected obstructive sleep apnea (OSA)
Inclusion criteria:
- Age above 18 years.
- Stable patient with suspected OSA
Exclusion Criteria:
- Age <18 years.
- Pregnant females
- Hemodynamically unstable patients
- Patient with Chronic diseases like COPD, CHF, CKD, CLD. DM and Stroke
- Patient with hematologic malignancies
- Patient on anticoagulants
- Patients with recent blood transfusion
- Patient with psychosis Method
The patients enrolled in this study will be subjected to the following:
- Full history taking and physical examination
- OSA screening: ESS, Berlin questionnaire and STOP-Bang questionnaire,
- Pulse oximetry
- Full night attended polysomnography (PSG)
Laboratory Investigations:
- Complete blood picture (done in the morning after the night of monitored sleep by PSG. With stress on red blood cell indices (RBC count, MCV, MCH, RDW)
- Arterial blood gases if needed
- Routine kidney function and liver function tests.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Dakhlia
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Mansoura, Dakhlia, Egypt, 050
- Tamer Awad Elsayed
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 1. Age above 18 years. 2. Stable patient with suspected OSA
Exclusion Criteria:
- 1. 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Red Blood Cells Indices
Time Frame: one night
|
Red Blood Cells Indices
|
one night
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- R.23.12.2429
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
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LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
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Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
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University of California, Los AngelesRecruiting
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Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
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State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
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The Hospital for Sick ChildrenCompleted
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Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
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State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
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Somnics, Inc.UnknownObstructive Sleep Apnea of AdultTaiwan
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ApnimedCompletedOSA - Obstructive Sleep ApneaUnited States