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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964324
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : March 11, 2020
Sponsor:
Collaborator:
Bispebjerg Hospital
Information provided by (Responsible Party):
Christian von Buchwald, Rigshospitalet, Denmark

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.


Condition or disease Intervention/treatment Phase
Snoring Obstructive Sleep Apnea Asthma Airway Disease Inflammatory Disease Concomitant Disease Diagnostic Test: Fractioned Exhaled Nitrogen Oxide measurements Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Improving Diagnostics of Concurrent Inflammatory Airway Diseases in Private ENT Practice - a Study of NO Measurements in Screening for Asthma and OSA in Patients Suffering From Severe Snoring
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Snoring

Arm Intervention/treatment
Experimental: Severe snorers
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
Measurements of Fractioned Exhaled Nitrogen Oxide obtained by blowing into a mouthpiece. The NIOX VERO machine will be used for these measures.




Primary Outcome Measures :
  1. Fractioned Exhaled Nitric Oxide (FeNO) [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. Nasal Nitric Oxide (nNO) [ Time Frame: 3 years ]

    Nasal Nitric Oxide (nNO) parts per billion (ppb) will be measured both as tidal breathing (TB-nNO) and as expiration against resistance (ER-nNO). A portable nitric oxide analyzer device (NIOX VERO, Circassia AB, Uppsala, Sweden) will be used for all nNO´s.

    TB-nNO is a measurement of the level of nitric oxide from one side of the nose as the patient breathes through the open mouth. The device will collect data for 30 s. Results vary in ppb from 5-1500 (580 is the mean for healthy subjects).

    ER-nNO will be performed while the patient breathes through the mouth against a restrictor (mouthpiece). After a complete inhalation to the full capacity of the lungs the patient will exhale against the restrictor with the lips closed around the mouthpiece. The patient should exhale steadily for 30 s as the device measures nitric oxide from one side of the nose. Results vary in ppb from 5-1500 with (915 is the mean for healthy subjects).


  2. Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 3 years ]

    Spirometry will be performed using MiniSpir Spiro (Alere A/S Denmark). With a nose clip on the nose patients will be instructed to exhale into a mouthpiece after inhalation to full capacity of the lungs.

    The FEV1 (forced expiratory volume in 1 s) is the volume exhaled during the 1st second of a forced exhalation measured in liters. Values below 80 % of the expected normal value, matched by age and height, is considered significantly reduced. The normal value for a 175 cm tall and 50-year-old male is 3,50 L. The normal value for a similar female is 2,99 L.


  3. Apnea Hypopnea Index (AHI) [ Time Frame: 3 years ]
    Cardio Respiratory Monitoring (CRM) will be performed using SOMNOtouch RESP. As an overnight home-study the equipment will measure flow of air and snoring using a nasal cannula. Puls rate, oxygen saturation and heartrate will be measured as well as movement of the thorax and abdomen and body position. Based on these registrations the system will calculate an AHI (apnea-hypopnea index). This index is the average sum of apneas and hypopneas per hour of sleep. An apnea is a full cessation of breathing for a minimum of 10 s followed by a desaturation of at least 3%. A hypopnea is a 50% or larger reduction in breathing for a minimum of 10s. An index below 5 is normal. An index above 5 is diagnostic of obstructive sleep apnea.

  4. Sino Nasal Outcome Test (questionnaire) [ Time Frame: 3 years ]
    SNOT-22 (Sino Nasal Outcome Test). 22 questions on sino nasal symptoms. Answers rank from 0-5 where 0 is "not a problem" and 5 is "worst possible problem". Total scores range from 0-110.

  5. ESS (questionnaire) [ Time Frame: 3 years ]
    ESS (Epworth Sleepiness Scale). 8 questions on daytime sleepiness in every-day situations. Answers rank from 0-3 where 0 is "not a problem" and 3 is "would fall asleep". Total scores range from 0-24. A score higher than 9 is considered excessive daytime sleepiness and indicates a risk of having obstructive sleep apnea.

  6. Short Form 36 questionnaire [ Time Frame: 3 years ]

    The SF-36 questionnaire (Short Form 36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. The original SF-36 stemmed from the Medical Outcome Study, MOS, which was conducted by the RAND Corporation.

    The questionnaire of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The scores are calculated using special software.


  7. ACQ (questionnaire) [ Time Frame: 3 years ]

    ACQ (asthma control questionnaire). The ACQ has 7 questions. Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).

    The ACQ can identify the adequacy of asthma control in individual patients. In general, patients with a score below 1.0 will have adequately controlled asthma and above 1.0 their asthma will not be well controlled.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03964324


Contacts
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Contact: Eva K Kiaer, M.D. +45 35 45 66 35 eva.kirkegaard.kiaer.01@regionh.dk

Locations
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Denmark
University Hospital of Copenhagen, Rigshospitalet Recruiting
Copenhagen, Region Hovedstaden, Denmark, 2100
Contact: Eva Kiær, MD    26701710    eva.kirkegaard.kiaer.01@regionh.dk   
Sponsors and Collaborators
Christian von Buchwald
Bispebjerg Hospital
Investigators
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Principal Investigator: Eva K Kiaer Rigshospitalet, Denmark
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Responsible Party: Christian von Buchwald, Clinical Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03964324    
Other Study ID Numbers: SNO07052019NOEKK
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Sleep Apnea, Obstructive
Snoring
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Sounds
Signs and Symptoms, Respiratory
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action