NO Measurements in Screening for Asthma and OSA, in Patients With Severe Snoring

NCT03964324 | Completed DMC

• 1 other identifier: SNO07052019NOEKK
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

In Denmark an estimated 200.000 patients suffer from obstructive sleep apnoea (OSA). The breathing pauses during sleep result in varying degrees of symptoms ranging from none over disturbed sleep to severe daytime sleepiness and cognitive deficits such as reduced short-term memory and difficulty concentrating. In addition, it increases the risk of hypertension, cardiovascular thromboembolic disease and type-2 diabetes as well as causing a 3-6 times increased risk of being involved in traffic accidents. Recent studies suggest that measurement of fractioned exhaled nitrogen oxide (FeNO) from the upper airway may be used as marker for airway inflammation. Studies have demonstrated that inflammation of the airway is present in OSA. In this study the investigators want to see whether FeNO measurements from the upper airway can be used to screen severe snorers for OSA. OSA is rarely diagnosed in patients with chronic rhinosinusitis (CRSwNP) or asthma. The connection between these three inflammatory conditions and the level of FeNO has not previously been investigated but might be clarified in our study. Patients suffering from severe snoring will be offered inclusion. The patients will undergo an ENT examination as well as FeNO testing and testing of lung function. A sleep study will be made as well as they will be asked to fill out questionnaires on sleep quality, nasal symptoms, lung function and their health in general.

Conditions

Snoring; Obstructive Sleep Apnea; Asthma; Airway Disease; Inflammatory Disease; Concomitant Disease

Outcome Measures

Primary Outcomes (1)

• Fractioned Exhaled Nitric Oxide (FeNO)

  Fractioned exhaled nitric oxide (FeNO) parts per billion (ppb) will be measured at an exhalation flow rate of 0.05 L/s, during single exhalation, using a portable nitric oxide analyzer device (NIOX VERO, Circassia AB, P.O. Box 3006 SE-750 03 Uppsala, Sweden). The normal exhaled NO values during measurements will be set to 5-35 ppb for healthy adults. Patients must produce a 10-second exhalation of breath at an exhalation pressure of 10-20 cmH2O to maintain a stable flow rate of 50±5 mL/s. A calibrated electrochemical sensor evaluates the final 3 seconds of exhalation expressing results in ppb with a range between 5 ppb and 300 ppb. The higher the measurement the larger is the risk of airway inflammation.

  3 years

Secondary Outcomes (7)

• Nasal Nitric Oxide (nNO)

  3 years

• Forced Expiratory Volume in 1 second (FEV1)

  3 years

• Apnea Hypopnea Index (AHI)

  3 years

• Sino Nasal Outcome Test (questionnaire)

  3 years

• ESS (questionnaire)

  3 years

Study Arms (1)

Severe snorers

EXPERIMENTAL

Study group that will undergo fractioned exhaled nitrogen oxide measurements as well as tests of lungfunction and sleep studies. All tests are noninvasive.

Diagnostic Test: Fractioned Exhaled Nitrogen Oxide measurements

Interventions

Fractioned Exhaled Nitrogen Oxide measurements DIAGNOSTIC_TEST

Measurements of Fractioned Exhaled Nitrogen Oxide obtained by blowing into a mouthpiece. The NIOX VERO machine will be used for these measures.

Severe snorers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe snorers that seek help based on their personal health and/or social limitations due to their snoring.

You may not qualify if:

• Patients with known OSA
• Patients with nasal polyps
• Other inflammatory diseases of the upper airways (i.e. cystic fibrosis, primary ciliary dyskinesis) or immune deficiencies, sarcoidosis or systemic vasculitis
• Infections in the upper airway during the past two weeks
• Smokers
• Treatment with antidepressant or sedative drugs
• Age below 18
• Patients unable to give an informed consent
• Patients that do not speak or read Danish

Sponsors & Collaborators

• Christian von Buchwald: lead
• Bispebjerg Hospital: collaborator

Study Sites (1)

University Hospital of Copenhagen, Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

Related Publications (1)

• Kiaer E, Ravn A, Jennum P, Praetorius C, Welinder R, Orntoft S, von Buchwald C, Backer V. Fractional exhaled nitric oxide-a possible biomarker for risk of obstructive sleep apnea in snorers. J Clin Sleep Med. 2024 Jan 1;20(1):85-92. doi: 10.5664/jcsm.10802.

  PMID: 37707290 DERIVED

MeSH Terms

Conditions

Snoring; Sleep Apnea, Obstructive; Asthma

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Eva K Kiaer

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 28, 2019
• Study Start: September 17, 2019
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

DK (1)