Effect of CPAP Treatment on Asthma Control in Patients With Severe Uncontrolled Asthma and Obstructive Sleep Apnea: The ASTHMA-SLEEP Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Asthma control test
研究概览
简要总结
The aim of the study is to evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea (OSA)
详细描述
Background: The prevalence of obstructive sleep apnea (OSA) is high in patients with severe uncontrolled asthma and can worsen asthma control. Previous observational studies demonstrated that CPAP treatment could improve control in patients with mild-moderate asthma. Nevertheless, there are no studies in patients with severe uncontrolled asthma.
Primary objective: To evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and AOS.
Methodology: Multicenter, prospective, randomized, controlled clinical trial with parallel groups in subjects with severe uncontrolled asthma who are older than 18 years and without sleepiness (Epworth sleepiness scale score ≤10). All included subjects will undergo conventional polysomnography and those with an apnea-hypopnea index (AHI) ≥15/hour will be randomized in a 1:1 ratio to receive conservative treatment or conservative treatment plus CPAP. Monitoring will be carried out during12 months. Patients will be evaluated at inclusion, at 1 month, 6 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Diagnosis of severe uncontrolled asthma according to the criteria of the Spanish Asthma Management Guide (GEMA) or the Global Initiative for Asthma (GINA) and no hospitalizations the month prior to inclusion in the study.
- •Apnea hypopnea rate greater than or equal to 15/hour
- •Punctuation in the Epworth Sleepiness Scale ≤10
- •Obtaining informed consent.
排除标准
- •Previous treatment with CPAP
- •Patient with central sleep apnea or Cheyne-Stokes respiration
- •Other sleep disorders: narcolepsy, restless leg syndrome, chronic insomnia,
- •Resistant hypertension
- •Active Smoking
- •Unstable comorbidities or medications may interfere with asthma control
- •Pregnancy
- •Any process that reduces life expectancy to <1 year,
- •Any medical or social factor that may limit CPAP compliance
研究组 & 干预措施
Conservative treatment
Subjects allocated to this arm will receive hygienic and dietary measures counselling
干预措施: Hygienic and dietary advice (Other)
CPAP treatment
Subjects allocated to this arm will receive treatment with continuous positive airway pressure (CPAP)
干预措施: CPAP treatment (Device)
结局指标
主要结局
Asthma control test
时间窗: 12 months
To evaluate the impact of CPAP treatment on asthma control based on the Asthma control test (ACT)
Asthma control questionnaire
时间窗: 12 months
To evaluate the impact of CPAP treatment on asthma control based on the Asthma control questionnaire (ACQ)
次要结局
- Lung function-forced vital capacity (FVC) in spriometry(12 months)
- Inflammatory profile(Baseline and 12 months)
- Lung function- forced expiratory volume in the first second (FEV1) in spirometry(12 months)
- Prevalence of OSA in severe uncontrolled asthma(Baseline)
- Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire)(12 months)
研究者
Mireia Dalmases
Principal investigator
Hospital Clinic of Barcelona