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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Fractioned Exhaled Nitric Oxide (FeNO)
研究概览
简要总结
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.
详细描述
Hypothesis FeNO can be used as screening tool for concurrent OSA and asthma in severe snorers.
Design The study is a prospective, observational multicenter trial. Patients are recruited from three different private specialist ENT-clinics where they will be offered inclusion according to guidelines. They will not be randomized and there will not be a group of patient controls.
The patients will undergo a full ENT-examination including a fiberoptic examination of both nasal cavities and the upper airway. NO-measurements as well as tests of lung function and sleep studies (Cardio-Respiratory-Monitoring = CRM) will also be performed. Furthermore, patients will be asked to fill out three questionnaires (see below). Patients with severe snoring and mild OSA will be offered an evaluation and a DISE (Drug Induced Sedation Endoscopy) at the ENT department Rigshospitalet, Gentofte.
NO-measurements:
FeNO-measurements will be carried out using a handheld NO-device (NIOX VERO, Aerocrine AB, Solna, Sweden). The patients will be asked to blow into a mouthpiece on the device which will then calculate the level of FeNO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Severe snorers that seek help based on their personal health and/or social limitations due to their snoring.
排除标准
- •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
- •Treatment with antidepressant or sedative drugs
- •Age below 18
- •Patients unable to give an informed consent
- •Patients that do not speak or read Danish
结局指标
主要结局
Fractioned Exhaled Nitric Oxide (FeNO)
时间窗: 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.
次要结局
- ESS (questionnaire)(3 years)
- Apnea Hypopnea Index (AHI)(3 years)
- Short Form 36 questionnaire(3 years)
- Sino Nasal Outcome Test (questionnaire)(3 years)
- Nasal Nitric Oxide (nNO)(3 years)
- Forced Expiratory Volume in 1 second (FEV1)(3 years)
- ACQ (questionnaire)(3 years)
研究者
Christian von Buchwald
Clinical Professor
Rigshospitalet, Denmark