Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

22 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Activo, no reclutando

Descripción detallada

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 de estudio

De observación

Inscripción (Estimado)

200

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Tanta, Egipto
        • Tanta University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Método de muestreo

Muestra no probabilística

Población de estudio

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

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
• 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: Mohammed Sayed Hantira, professor, Tanta University
  • Silla de estudio: Ayman Hassan AbdElzaher, professor, Tanta University
  • Silla de estudio: Ahmed Gharib Gharib, assistant professor, cairo institute for research
  • Silla de estudio: Mohammed Samy Torky, assistant professor, Tanta University
  • Investigador principal: Martina Reda Abdo, lecturer, Tanta University
  • Silla de estudio: Aya Mohammed Rabeah, lecturer, Tanta University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

25 de mayo de 2026

Finalización primaria (Estimado)

1 de septiembre de 2026

Finalización del estudio (Estimado)

1 de octubre de 2026

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de mayo de 2026

Publicado por primera vez (Actual)

26 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de agosto de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir