Obstructive Sleep ApneaNCT06265129
The Association Between Obstructive Sleep Apnea Severity and Red Blood Cells Indices
An observational study of Obstructive Sleep Apnea, run by Mansoura University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- 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)
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2023to 20 Dec 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: a thirty (30) patients with suspected obstructive sleep apnea (OSA)
Who may be able to join
- 1. Age above 18 years. 2. Stable patient with suspected OSA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- 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)
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)Diagnostic test
morning after the night of monitored sleep by PSG. With stress on red blood cell indices (RBC count, MCV, MCH, RDW)
What is being measured
The primary outcome is the main question the study is designed to answer.
Red Blood Cells Indices
Red Blood Cells Indices
Measured: one night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start20 Mar 2023
- Primary completion20 Oct 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Awad, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265129
- Sponsor's protocol ID
- R.23.12.2429
- Status last verified
- Feb 2024
- First submitted
- 10 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Obstructive Sleep Apnea Severity and Red Blood Cells Indices
- ClinicalTrials.gov ID
- NCT06265129
- Acronym / sponsor ID
- R.23.12.2429
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- a thirty (30) patients with suspected obstructive sleep apnea (OSA)
Key inclusion criteria (1 listed)
- 1. Age above 18 years. 2. Stable patient with suspected OSA
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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)morning after the night of monitored sleep by PSG. With stress on red blood cell indices (RBC count, MCV, MCH, RDW) | Diagnostic test | – |
Primary outcome
Red Blood Cells Indices
Time frame: one night
Red Blood Cells Indices
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red Blood Cells Indices (time frame: one night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.