Obstructive Sleep ApneaNCT02272608
Evaluation of Sleep Apnea Related Inflammation With CRP, ESR and Neutrophil toLymphocyte Ratio
An observational study of Obstructive Sleep Apnea, run by Ordu University.
Trial summary
There is some evidence suggesting that OSA is associated with low level of systemic inflammation and oxidative stress. Low level systemic inflammation and subsequent vascular damage has been implicated as the underlying mechanism responsible for comorbidities. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Evaluation of Sleep Apnea Related Inflammation with CRP, ESR and Neutrophil toLymphocyte Ratio
- How many people
- 279 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Aug 2014
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from sleep apnea and were referred to perform polysomnoraphy constituted the study groups. There were grouped into 4 according to apnea- hypopnea scores: control, mild apnea, moderate apnea and severe apnea.
Inclusion Criteria: Subjects who were referred for polysomnography (PSG) testing and performed the test were included Exclusion Criteria: Patients with malignancy, diabetes mellitus, dyslipidemia, cardiovascular disease or hypertension, chronic inflammatory processes, thyroid dysfunction, chronic hepatic disease, renal failure, any acute- subacute infectious disease within past 2 months, if data are incomplete such as blood sample testing results, if they were unable to perform complete PSG testing.
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About this study
There is some evidence suggesting that OSA is associated with low level of systemic inflammation and oxidative stress. Low level systemic inflammation and subsequent vascular damage has been implicated as the underlying mechanism responsible for comorbidities. Detection of altered inflammatory markers in OSAS patients may predict the degree of nocturnal sleep disturbance and associated systemic inflammation and presence of comorbidities. Recently, novel inflammatory biomarkers, such as neutrophil to lymphocyte ratio (NLR) have been proposed as an indicator of systemic inflammation. To our knowledge, NLR has not been studied in OSAS. We conducted the present study to evaluate the association between OSAS and inflammatory markers CRP, ESR and NLR.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Evaluation of Sleep Apnea Related Inflammation with CRP, ESR and Neutrophil toLymphocyte Ratio
- 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.
Evaluation of Sleep Apnea Related Inflammation with CRP, ESR and Neutrophil toLymphocyte RatioOther
CRP, ESR and Neutrophil toLymphocyte Ratio values of sleep apnea patients were evaluated with respect to apnea- hypopnea scores.
| Study group | Role | What they receive |
|---|---|---|
| control | patients WHO do not have sleep apnea Receives: Other: Evaluation of Sleep Apnea Related Inflammation with CRP, ESR and Neutrophil toLymphocyte Ratio | |
| mild OSAS | mild apnea patients (AHI: 5-15) Receives: Other: Evaluation of Sleep Apnea Related Inflammation with CRP, ESR and Neutrophil toLymphocyte Ratio | |
| moderate OSAS | moderate apnea patients (AHI: 16-30) Receives: Other: Evaluation of Sleep Apnea Related Inflammation with CRP, ESR and Neutrophil toLymphocyte Ratio | |
| severe OSAS | severe OSAS patients (AHI: more than 30) Receives: Other: Evaluation of Sleep Apnea Related Inflammation with CRP, ESR and Neutrophil toLymphocyte Ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of systemic inflammatory markers C-Reactive Protein, Erythrocyte Sedimentation Ratio and neutrophil to lymphocyte ratio in sleep apnea patients
Measured: After withdrawal of serum samples, patients were taken to sleep lab at the same day and polysomnography reports were evaluated 24 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startNov 2012
- Primary completionJun 2014
- Study completionAug 2014
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
- Retrospective
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan Korkmaz, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272608
- Sponsor's protocol ID
- Ordu University
- Status last verified
- Oct 2014
- First submitted
- 12 Oct 2014
- Last updated
- 23 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sleep Apnea Related Inflammation With CRP, ESR and Neutrophil toLymphocyte Ratio
- ClinicalTrials.gov ID
- NCT02272608
- Acronym / sponsor ID
- Ordu University
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 23 Oct 2014 (estimated)
- 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.
There is some evidence suggesting that OSA is associated with low level of systemic inflammation and oxidative stress. Low level systemic inflammation and subsequent vascular damage has been implicated as the underlying mechanism responsible for comorbidities. Detection of altered inflammatory markers in OSAS patients may predict the degree of nocturnal sleep disturbance and associated systemic inflammation and presence of comorbidities. Recently, novel inflammatory biomarkers, such as neutrophil to lymphocyte ratio (NLR) have been proposed as an indicator of systemic inflammation. To our knowledge, NLR has not been studied in OSAS. We conducted the present study to evaluate the association between OSAS and inflammatory markers CRP, ESR and NLR.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | – | Other: Evaluation of Sleep Apnea Related Inflammation with CRP, ESR and Neutrophil toLymphocyte Ratiopatients WHO do not have sleep apnea |
| mild OSAS | – | Other: Evaluation of Sleep Apnea Related Inflammation with CRP, ESR and Neutrophil toLymphocyte Ratiomild apnea patients (AHI: 5-15) |
| moderate OSAS | – | Other: Evaluation of Sleep Apnea Related Inflammation with CRP, ESR and Neutrophil toLymphocyte Ratiomoderate apnea patients (AHI: 16-30) |
| severe OSAS | – | Other: Evaluation of Sleep Apnea Related Inflammation with CRP, ESR and Neutrophil toLymphocyte Ratiosevere OSAS patients (AHI: more than 30) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from sleep apnea and were referred to perform polysomnoraphy constituted the study groups. There were grouped into 4 according to apnea- hypopnea scores: control, mild apnea, moderate apnea and severe apnea.
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 |
|---|---|---|
| Evaluation of Sleep Apnea Related Inflammation with CRP, ESR and Neutrophil toLymphocyte RatioCRP, ESR and Neutrophil toLymphocyte Ratio values of sleep apnea patients were evaluated with respect to apnea- hypopnea scores. | Other | control, mild OSAS, moderate OSAS, severe OSAS |
Primary outcome
Evaluation of systemic inflammatory markers C-Reactive Protein, Erythrocyte Sedimentation Ratio and neutrophil to lymphocyte ratio in sleep apnea patients
Time frame: After withdrawal of serum samples, patients were taken to sleep lab at the same day and polysomnography reports were evaluated 24 hours later
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 23 Oct 2014.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Ordu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Evaluation of systemic inflammatory markers C-Reactive Protein, Erythrocyte Sedimentation Ratio and neutrophil to lymphocyte ratio in sleep apnea patients (time frame: After withdrawal of serum samples, patients were taken to sleep lab at the same day and polysomnography reports were evaluated 24 hours later). 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 23 Oct 2014.