Fractional Exhaled Nitric Oxide and CRP Levels in Egyptian Patients With Obstructive Sleep Apnea Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Full-night PSG was performed,
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •inflammatory disorders
- •cardiovascular disease,
- •on regular medication including (nasal/inhaled/oral corticosteroids, antihistaminic, cysteinyl leukotriene receptor inhibitors) -
Arms & Interventions
Patients
full night PSG (polysomnogram) was done, fractional exhaled nitric oxide and Hs-CRP were measured
Intervention: Fractional exhaled nitric oxide and CRP levels (Diagnostic Test)
control
CRP level was measured
Intervention: Fractional exhaled nitric oxide and CRP levels (Diagnostic Test)
Outcomes
Primary Outcomes
Full-night PSG was performed,
Time Frame: one year
Measurement of FeNO and Hs-CRP with three month intervals of CPAP
Secondary Outcomes
No secondary outcomes reported
Investigators
mona abdel mawla Ahmed El wassefy
faculty of medicine Mansoura University
Mansoura University