NCT01026298已完成不适用
The Relationship Between Asthma and Obstructive Sleep Apnea (OSA) - A Pilot Study of the Effects of OSA and Its Treatment on Asthma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 744
- 试验地点
- 2
- 主要终点
- To determine the prevalence and risk factors for OSA symptoms in a specialty clinic-based sample of individuals with asthma.
研究概览
简要总结
Obstructive sleep apnea (OSA) is a common but under-diagnosed form of sleep disordered breathing (SDB). Asthma is a common disease with rising prevalence, which continues to pose significant morbidity and costs. In spite of considerable progress in our understanding of asthma, a large number of individuals with asthma continue to have symptoms and subsequently, have a poor functional status, poor quality of life and increased health care costs. In many cases no apparent cause is found and optimal therapy does not achieve its goal. While recent data suggests that OSA is common in severe asthma, the prevalence of OSA and its predisposing factors have not been studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 73 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of not well-controlled (NWC) asthma (National Asthma Education and Prevention Program Guidelines step 2, 3, 4), as diagnosed by an asthma physician
- •stable doses of standard therapy for 2 months prior to enrollment. These regimens will include: inhaled corticosteroids (ICS) for mild-persistent step; ICS and inhaled long-acting β-adrenergics (LABA) or ICS and leukotriene modifier (LTMs) agents for moderate-persistent step; high doses of ICS, LABA or LTMs, with or without oral steroids at stable doses, for patients in severe step
- •adherence to the current asthma medications regimen, demonstration of a proper inhaler technique; agreement for maintaining the same asthma regimen (except rescue bronchodilators) as clinical condition permits (if an exacerbation occurs during the first 4-week period, the subject will be excluded as discussed below), and willingness to complete diaries of asthma symptoms, rescue bronchodilator use, peak flow meter (PEF) recordings as well as asthma-related urgent doctor's and emergency room visits and hospitalizations for the 3 months duration of the study
- •moderate to high probability for OSA (SA-SDQ scores ≥31 for males and ≥28 for females) or high clinical suspicion for OSA
- •preliminary agreement to treatment with continuous positive airway pressure (CPAP) if OSA is identified and current CPAP treatment criteria are met [patients with moderate to severe OSA (AHI>15 events/hour), patients with mild OSA (AHI 5-15 events/hour) in association with EDS or co-morbid conditions (HTN, stable ischemic heart disease, prior stroke, impaired cognition, mood disorders, insomnia
- •ability to read and write
- •ability and willingness to return to the Medical Center as required by the study protocol.
排除标准
- •asthma exacerbation in the prior 2 months
- •acute sinusitis
- •poorly controlled rhinitis or gastroesophageal reflux disease (GERD)
- •any unstable medical or psychiatric illness likely to impede participation in the protocol during the next year
- •evidence of co-existent lung disease, in particular allergic broncho-pulmonary aspergillosis or chronic obstructive pulmonary disease (COPD)
- •treated OSA or another primary sleep disorder
- •evidence of medical instability due to OSA at first sleep study visit
- •subjects with excessive daytime sleepiness to a degree that puts the subject or people around at risk of accidents (motor vehicle or work-related). In these cases we will facilitate expedited sleep evaluations through primary providers
- •historical evidence of collagen vascular disease
- •craniofacial abnormalities precluding the use of CPAP; 11) current cigarette smoking or within the prior 6 months (self-report and medical records
- •pregnancy (documented via urine-human chorionic gonadotropin detection test) or desire to become pregnant during the following 3 months
- •mental impairment limiting the ability to provide informed consent
- •current alcohol (as per the NIH cutoffs56 presented below) or recreational drug use (for both, based on medical records review and self-report without any prospective recording); women drinking more than 3 drinks at one time or more than 7 standard drinks a week or men drinking more than 4 drinks at one time or more than 14 standard drinks a week will be excluded. A standard drink is defined as one can or bottle of beer (12 fl oz), one glass of wine (5 fl oz), or one mixed drink containing 1.5 fl oz of hard liquor.
结局指标
主要结局
To determine the prevalence and risk factors for OSA symptoms in a specialty clinic-based sample of individuals with asthma.
时间窗: 7 days
次要结局
- To examine whether 8 weeks of CPAP for OSA improves quality of life, insomnia, daytime sleepiness and fatigue, and health resource utilization in individuals with asthma.(56 days)
- To assess changes in subjective and objective asthma measures in subjects with asthma and co-morbid OSA, after 8 weeks of treatment with continuous positive airway pressure (CPAP) versus no intervention (control).(56 days)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Factors Correlated With Obstructive Sleep Apnea in Children and AdolescentsObstructive Sleep Apnea of ChildNCT04328402Federal University of Pelotas187
已完成
不适用
Immunological Consequences of Obstructive Sleep ApneaObstructive Sleep ApneaNCT00214071University of Wisconsin, Madison30
已完成
不适用
The Association Between Obstructive Sleep Apnea Severity and Red Blood Cells IndicesObstructive Sleep ApneaNCT06265129Mansoura University30
招募中
不适用
Sleep Apnea and Cognitive Function in Subjects With Subjective or Mild Cognitive ImpairmentObstructive Sleep ApneaMild Cognitive ImpairmentSubjective Cognitive ImpairmentNCT06089096The University of Hong Kong250
已完成
不适用
Sleep Apnea in Asthmatic Children and TeenagersAsthma, BronchialApnea, SleepSleep Apnea, Mixed Central and ObstructiveSleep Hypopnea (Diagnosis)Obstructive Sleep ApneaBronchial AsthmaObstructive Sleep Apnea SyndromeNCT03034447Federal University of São Paulo80