Fractional Exhaled Nitric Oxide and CRP Levels in Egyptian Patients With Obstructive Sleep Apnea Syndrome
Primary Purpose
OSA
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Fractional exhaled nitric oxide and CRP levels
Sponsored by
About this trial
This is an interventional diagnostic trial for OSA focused on measuring FeNO; ;;, Hs-CRP, CPAP, OSA
Eligibility Criteria
Inclusion Criteria:
fractional exhaled nitric oxide and Hs-CRP were measured next morning of PSG, CPAP for moderate to severe OSA patient was advised with measurement of FeNO and Hs-CRP after 3months of CPAP
- were ≥ 18 years old,
- non-smokers and
- excluded from any inflammatory disorders (allergy, bronchial asthma, gastro-esophageal reflux disease, cardiovascular diseases, and cerebrovascular diseases) or use of any regular medication including (nasal/inhaled/oral corticosteroids, antihistaminic, cysteinyl leukotriene receptor inhibitors),
- or had upper or lower respiratory tract infection 2 weeks prior to sampling.
- Control healthy subjects were also free from any sleep disorders symptoms. Cases were recruited from Sleep-disordered breathing unit out Patient Clinic in pulmonary medicine department - Mansoura University - Egypt.
Exclusion Criteria:
- smokers
- inflammatory disorders
- cardiovascular disease,
- on regular medication including (nasal/inhaled/oral corticosteroids, antihistaminic, cysteinyl leukotriene receptor inhibitors) -
Sites / Locations
- Mansoura Faculty Chest Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Patients
control
Arm Description
full night PSG (polysomnogram) was done, fractional exhaled nitric oxide and Hs-CRP were measured
CRP level was measured
Outcomes
Primary Outcome Measures
Full-night PSG was performed,
Measurement of FeNO and Hs-CRP with three month intervals of CPAP
Secondary Outcome Measures
Full Information
NCT ID
NCT04179942
First Posted
November 19, 2019
Last Updated
November 30, 2019
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT04179942
Brief Title
Fractional Exhaled Nitric Oxide and CRP Levels in Egyptian Patients With Obstructive Sleep Apnea Syndrome
Official Title
Fractional Exhaled Nitric Oxide and CRP Levels in Egyptian Patients With Obstructive Sleep Apnea Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
November 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Obstructive sleep apnea syndrome (OSAS) was associated with upper and lower respiratory tract inflammation, Fractional exhaled nitric oxide (FeNO) proposed as a marker of airway inflammation, few studies were done on the impact of continuous positive airway pressure (CPAP) on FeNO.
Aim of the work: to study the impact of continued positive airway pressure therapy on exhaled NO and using Hs-CRP as a marker of inflammation in obstructive sleep apnea syndrome.
Patient and Methods: This study is a case-control study including participants were newly diagnosed as OSAS and control recruited from sleep outpatient clinic, full night PSG was done, fractional exhaled nitric oxide and Hs-CRP were measured next morning of PSG, CPAP for moderate to severe OSA patient was advised with measurement of FeNO and Hs-CRP after 3months of CPAP Keywords: FeNO; Hs-CRP; CPAP; OSA. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Detailed Description
This study is a prospective 3 months follow up study including only (27) participants as a convenient sample for the cost limitations newly diagnosed as OSA and (10) healthy control.
inclusion characters All participants enrolled in this study
were ≥ 18 years old,
non-smokers and
excluded from any inflammatory disorders (allergy, bronchial asthma, gastro-esophageal reflux disease, cardiovascular diseases, and cerebrovascular diseases) or use of any regular medication including (nasal/inhaled/oral corticosteroids, antihistaminic, cysteinyl leukotriene receptor inhibitors), or
had an upper or lower respiratory tract infection 2 weeks prior to sampling. Control healthy subjects were also free from any sleep disorders symptoms. Cases were recruited from Sleep-disordered breathing unit out Patient Clinic in pulmonary medicine department - Mansoura University - Egypt. All participants in this study were evaluated by history taking with stress on OSAS questionnaires, anthropometric parameters measurement and spirometric pulmonary function (FEV1, FVC and FEV1/FVC ) all patients were subjected to laboratory, attended, full-night polysomnography using (SONMOscreenTMplus, SOMNOmedics, (Germany) with AASM standard montage, This included a standardized montage: two-channel electroencephalograms (EEG; C4/A1, C3/A2), bilateral electrooculogram (EOG), submental electromyogram (EMG), bilateral leg EMGs, and electrocardiography (ECG). Airflow was measured using a thermistor (Healthdyne Technologies), the respiratory effort was assessed by inductance plethysmography and oxygen saturation was recorded using a finger probe. The oxygen saturation signal was digitally sampled at 1 Hz and stored both on the PSG record and in a separate monitor for offline analysis.
studies were interpreted according to the last manual scoring criteria. The cases were diagnosed as severe OSA according to the third international classification of sleep disorders. Then they were classified according to apnea-hypopnea index (AHI) into two main groups: cases (AHI ≥5) (n=) and control (AHI˂5) (n=10). Cases were classified into two subgroups into severe OSA (AHI ≥ 30) (n=34) and moderate OSA (AHI (15-30) mild (n=10).
On the next morning of the study 30 min after PSG, the blood sample was collected for measuring of high sensitivity C- reactive protein (HS-CRP) by (The Immunospec Hs-CRP) ELISA, based on the principle of a solid phase enzyme-linked immunosorbent assay [15]. The assay system utilizes a unique monoclonal antibody directed against a distinct antigenic determinant on the CRP molecule.
fractional exhaled nitric oxide (FeNO) measurement: was measured by (NO breath®FeNO monitor-Bedfont scientific Ltd) according to international recommendations [16], with a single breath online method at constant flow of 50 mL/s or 12 seconds of exhalation of adults with a sensitivity of one part per billion (ppb) Calibration of the analyzer was automatically performed by the software. Briefly, after inhaling to total lung capacity, the subjects exhaled through a mouthpiece into an exhalation circuit. All subjects were asked to stop eating, drinking, and strenuous exercise for two hours prior to FeNO measurement.
CPAP therapy and follow up: 22 of 27 patients with moderate and severe OSA were advised to use CPAP therapy after full-night CPAP titration study in accordance with AASM recommendations [17]Preliminary education and adaptation for CPAP was performed 1hour prior to the beginning of CPAP titration.
An optimal titration study was defined as one in which an optimal CPAP pressure was reached that normalizes the AHI and eliminates snoring, desaturation, and arousals, and restores a normal flow contour [17] adjusted prescribed CPAP pressure after titration was administered during sleep for at least five hours per night, for at least five days per week for three consecutive months.
follow up sessions after CPAP therapy: were adjusted 1,2 and 3 months after starting CPAP therapy for evaluation of patients response and compliance to CPAP, Adherence to the CPAP therapy was evaluated after revision of the download information from the CPAP device.
Adherence was defined as CPAP use for an average of 4 h on
≥ 70% of the nights.
(FeNO) was also measured in the three follow up visit with CPAP follow up, however, BMI, spirometric pulmonary function(FEV1, FVC, and FEV1/FVC ) and high sensitivity C- reactive protein (HS-CRP) were measured after 3 months in last follow up visit of the study.
Five patients from 27 were lost in follow up sessions because they did not use CPAP.
Then data were analyzed using SPSS version 16 for Windows® (SPSS Inc, Chicago, IL, USA). Qualitative variables were presented as numbers and percentages. Chi-square test or Fisher exact test of significance was for comparison between groups, as appropriate. Quantitative variables were presented as mean ±SD. They were tested for normality distribution by the Kolmogorov-Smirnov test. In normally distributed variables unpaired t-test (t) was used. In abnormally distributed variables independent Mann-Whitney test (Z) was used. P-value ≤0.05 was considered statistically significant. For the detection of cut off points, we use the receiver operating characteristic (ROC) curve. Sensitivity, Specificity values were used for studying the selected cut off point for validation as a screening tool.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OSA
Keywords
FeNO; ;;, Hs-CRP, CPAP, OSA
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Active Comparator
Arm Description
full night PSG (polysomnogram) was done, fractional exhaled nitric oxide and Hs-CRP were measured
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
CRP level was measured
Intervention Type
Diagnostic Test
Intervention Name(s)
Fractional exhaled nitric oxide and CRP levels
Intervention Description
measurement of FeNO and Hs-CRP after 3months of CPAP
Primary Outcome Measure Information:
Title
Full-night PSG was performed,
Description
Measurement of FeNO and Hs-CRP with three month intervals of CPAP
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
fractional exhaled nitric oxide and Hs-CRP were measured next morning of PSG, CPAP for moderate to severe OSA patient was advised with measurement of FeNO and Hs-CRP after 3months of CPAP
were ≥ 18 years old,
non-smokers and
excluded from any inflammatory disorders (allergy, bronchial asthma, gastro-esophageal reflux disease, cardiovascular diseases, and cerebrovascular diseases) or use of any regular medication including (nasal/inhaled/oral corticosteroids, antihistaminic, cysteinyl leukotriene receptor inhibitors),
or had upper or lower respiratory tract infection 2 weeks prior to sampling.
Control healthy subjects were also free from any sleep disorders symptoms. Cases were recruited from Sleep-disordered breathing unit out Patient Clinic in pulmonary medicine department - Mansoura University - Egypt.
Exclusion Criteria:
smokers
inflammatory disorders
cardiovascular disease,
on regular medication including (nasal/inhaled/oral corticosteroids, antihistaminic, cysteinyl leukotriene receptor inhibitors) -
Facility Information:
Facility Name
Mansoura Faculty Chest Hospital
City
Mansoura
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Fractional Exhaled Nitric Oxide and CRP Levels in Egyptian Patients With Obstructive Sleep Apnea Syndrome
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