Fractional Exhaled Nitric Oxide and CRP Levels in Egyptian Patients With Obstructive Sleep Apnea Syndrome

NCT04179942 | Completed

• 1 other identifier: MS.16.06.82
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

OSA

Keywords

FeNO; ;;; Hs-CRP; CPAP; OSA

Outcome Measures

Primary Outcomes (1)

• Full-night PSG was performed,

  Measurement of FeNO and Hs-CRP with three month intervals of CPAP

  one year

Study Arms (2)

Patients

ACTIVE COMPARATOR

full night PSG (polysomnogram) was done, fractional exhaled nitric oxide and Hs-CRP were measured

Diagnostic Test: Fractional exhaled nitric oxide and CRP levels

control

PLACEBO COMPARATOR

CRP level was measured

Diagnostic Test: Fractional exhaled nitric oxide and CRP levels

Interventions

Fractional exhaled nitric oxide and CRP levels DIAGNOSTIC_TEST

measurement of FeNO and Hs-CRP after 3months of CPAP

Patients; control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• smokers
• inflammatory disorders
• cardiovascular disease,
• on regular medication including (nasal/inhaled/oral corticosteroids, antihistaminic, cysteinyl leukotriene receptor inhibitors) -

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura Faculty Chest Hospital

Al Mansurah, Egypt

Location

MeSH Terms

Interventions

Fractional Exhaled Nitric Oxide Testing

Intervention Hierarchy (Ancestors)

Breath Tests; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: faculty of medicine Mansoura University

Study Record Dates

• First Submitted: November 19, 2019
• First Posted: November 27, 2019
• Study Start: June 6, 2017
• Primary Completion: August 15, 2018
• Study Completion: November 20, 2018
• Last Updated: December 3, 2019

Record last verified: 2019-11

Locations

EG (1)