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Fractional Exhaled Nitric Oxide as Possible Non - Invasive Biomarker to Assess Obstructive Sleep Apnea Severity

28 maggio 2026 aggiornato da: Martina Reda Abdo, Tanta University

Aim of work

  1. Primary aim: Asses correlation between FeNO level, OSA severity
  2. Secondary aim: Clarifying FeNO's role as a biomarker to assess airway inflammation, Cut off value prediction to moderate and severe OSA and its potential significance to improve clinical management strategies for OSA patients.

Panoramica dello studio

Stato

Attivo, non reclutante

Descrizione dettagliata

Obstructive Sleep Apnea is a highly prevalent sleep-related breathing disorder characterized by recurrent episodes of upper airway obstruction during sleep, resulting in intermittent hypoxia, sleep fragmentation, and significant cardiometabolic consequences. The severity of OSA is traditionally assessed using overnight polysomnography (PSG), with the apnea-hypopnea index (AHI) serving as the gold standard metric. However, PSG is resource-intensive, time-consuming, and not readily accessible in many healthcare settings, particularly in resource-limited environments. This has driven increasing interest in identifying reliable, non-invasive biomarkers that could aid in the assessment of disease severity and reduce dependence on PSG.(1) Airway and systemic inflammation play a central role in the pathophysiology of OSA. Recurrent hypoxia-reoxygenation cycles induce oxidative stress and activate inflammatory pathways, leading to endothelial dysfunction and tissue injury.(1) Fractional exhaled nitric oxide (FeNO) is a well-established non-invasive biomarker of airway inflammation, widely used in the assessment of eosinophilic airway diseases such as asthma. Given its ability to reflect inflammatory processes within the respiratory tract, FeNO has been proposed as a potential marker in OSA.(2) Several studies have explored the relationship between FeNO levels and OSA. Some have demonstrated elevated FeNO levels in patients with OSA compared to healthy controls, along with positive correlations between FeNO and indices of disease severity such as AHI and oxygen desaturation index (ODI).(3) In contrast, other studies have reported inconsistent or weak associations, suggesting that the inflammatory profile in OSA (often predominantly neutrophilic rather than eosinophilic) may limit the specificity of FeNO as a biomarker in this context.

Importantly, the current literature is characterized by several limitations. Many studies have small sample sizes, heterogeneous populations, and inadequate control for confounding factors such as smoking, obesity, and coexisting airway diseases. Furthermore, most studies focus primarily on simple correlations with AHI, without evaluating the diagnostic performance of FeNO or its ability to discriminate between different severity categories of OSA. The absence of robust predictive models integrating FeNO with clinical parameters further limits its applicability in routine clinical practice.(4) Therefore, a significant gap remains regarding whether FeNO can serve as a clinically meaningful, non-invasive biomarker for stratifying OSA severity. In particular, there is a need for well-designed studies that not only assess the association between FeNO and polysomnographic parameters, but also evaluate its diagnostic accuracy and potential role within predictive models.

Accordingly, the present study aims to investigate the role of FeNO in assessing the severity of OSA, to determine its relationship with key polysomnographic indices, and to evaluate its potential utility as a non-invasive tool for disease stratification.

Tipo di studio

Osservativo

Iscrizione (Stimato)

200

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Tanta, Egitto
        • Tanta University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Study Type: prospective observational cross sectional study. Sample Size: This study will be carried out on 200 patients' suspected for obstructive sleep apnea, following approval of medical research ethical committee of Tanta University, Faculty of Medicine.

Sample size was calculated using this formula 2SD ^2 × (1.96 + 0.84)^2 /d^2 SD of FeNO 50 at moderate OSA 17.25 d is the difference between both means 21, 13.57 So at power of study 80% CI 95% Least Sample size will be 85 in each group

Descrizione

Inclusion Criteria:

  • Ages Eligible for study: 18 years till 70 years old.
  • Newly suspected OSA patients with Epworth Sleepiness Scale (ESS) ≥ 10.

Exclusion Criteria:

  • Current smokers.
  • Any chronic Respiratory disorders other than OSA (asthma, COPD, allergic rhinitis, and atopic diseases).
  • Younger age than 18 years.
  • Recent inhaled or systemic corticosteroids within the pasr 4 weeks.
  • Recent respiratory infection less than 4 weeks.
  • Uncontrolled diabetes & any chronic debilitating diseases (liver, renal, collagen diseases) Informed Consent will be taken from the participants before clinical examination.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
• Control group AHI less than 5 \ hour - case groups Milld OSA & moderate to severe OSA

All 200 participants will undergo:

  • History taking including: Age, sex, occupation, residence, education, and special habits e.g., smoking
  • Plain chest x ray& PFT to exclude any other chest diseases (asthma& COPD)
  • The participants' Blood pressure, height and weight will be measured, and body mass index will be calculated.
  • Daytime sleepiness will be assessed by the Epworth Sleepiness Scale and a value of 10 or more denoting as excessive daytime sleepiness.
  • Full laboratory investigation to exclude any chronic diseases.
  • Full-night PSG in chest department, Tanta university hospital.
  • FENO level base line at 9 am after PSG night & interpretation accordin
  • After PSG result, cases will be divided in 3 groups

    • Control group AHI less than 5 \ hour
    • Mild OSA group AHI than 5-15 \ hour
    • Mod to severe OSA more than 15 \ hour

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Asses correlation between FeNO level, OSA severity• through measuring FeNo level in 3 groups which will be divided according to AHI in PSG study -Control group AHI less than 5 \ hour, Mild OSA group AHI than 5-15 \ hour, Moderate to severe OSA group
Lasso di tempo: baseline

address the correlation between PSG parameters performed by Somno medics screen including (apnea hypopnea index (event\ hour) oxygen nadir(%), oxygen desaturation index, % of time desaturation below 90% (T90), snoring index) and FeNo level ppb which measured by (Bedfont NIN006187 Nobreath) to Clarify FeNO's role as a biomarker to assess airway inflammation, and OSA severity, address FeNoCut off value as prediction tool to moderate and severe OSA and its potential significance to improve clinical management strategies for OSA patients.

FeNo measurement precaution will be addressed as the participants will be asked to abstain from eating, drinking, and exercise, and avoid exposure to tobacco fumes 60 minutes before testing, so all cases FeNO assay will be hold at 9 am, Ask patients to refrain from Intake of nitrate-containing food like green-leaved vegetables on the day of assessment and then will be interprated according to ATS guidelines

baseline

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Mohammed Sayed Hantira, professor, Tanta University
  • Cattedra di studio: Ayman Hassan AbdElzaher, professor, Tanta University
  • Cattedra di studio: Ahmed Gharib Gharib, assistant professor, cairo institute for research
  • Cattedra di studio: Mohammed Samy Torky, assistant professor, Tanta University
  • Investigatore principale: Martina Reda Abdo, lecturer, Tanta University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

25 maggio 2026

Completamento primario (Stimato)

1 settembre 2026

Completamento dello studio (Stimato)

1 ottobre 2026

Date di iscrizione allo studio

Primo inviato

12 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 maggio 2026

Primo Inserito (Effettivo)

26 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

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Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Apnea ostruttiva del sonno (OSA)

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