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

NCT07606898 | Active Not Recruiting

• 1 other identifier: FeNo in OSA
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of work

1. 1.Primary aim: Asses correlation between FeNO level, OSA severity
2. 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.

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

• 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

  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

Study Arms (1)

• 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Egypt

Location

Related Publications (4)

• Slowik JM, Sankari A, Collen JF. Obstructive Sleep Apnea. 2025 Mar 4. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459252/

  PMID: 29083619 BACKGROUND

• Ragnoli B, Radaeli A, Pochetti P, Kette S, Morjaria J, Malerba M. Fractional nitric oxide measurement in exhaled air (FeNO): perspectives in the management of respiratory diseases. Ther Adv Chronic Dis. 2023 Aug 1;14:20406223231190480. doi: 10.1177/20406223231190480. eCollection 2023.

  PMID: 37538344 BACKGROUND

• Zhu Q, Huang L, Zhu L, Zhang X, Ji H, Niu D, Ji W, Ma Q, Chen R, Shi H, Wang Y, Xu L. Association Between Fractional Exhaled Nitric Oxide (FeNO) and Cognitive Function in Patients with Obstructive Sleep Apnea. Nat Sci Sleep. 2025 Jul 12;17:1603-1614. doi: 10.2147/NSS.S524831. eCollection 2025.

  PMID: 40672996 BACKGROUND

• Michils A, Akset M, Haccuria A, Perez-Bogerd S, Malinovschi A, Van Muylem A. The Impact of Airway Obstruction on Feno Values in Asthma Patients. J Allergy Clin Immunol Pract. 2024 Jan;12(1):111-117. doi: 10.1016/j.jaip.2023.08.027. Epub 2023 Aug 25.

  PMID: 37634805 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Mohammed Sayed Hantira, professor

  Tanta University

  STUDY DIRECTOR

• Ayman Hassan AbdElzaher, professor

  Tanta University

  STUDY CHAIR

• Ahmed Gharib Gharib, assistant professor

  cairo institute for research

  STUDY CHAIR

• Mohammed Samy Torky, assistant professor

  Tanta University

  STUDY CHAIR

• Martina Reda Abdo, lecturer

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator, lecturer & consultant of chest diseases Tanta university

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 26, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

EG (1)