An Observational Study of the Effects of Nocturnal Hypoxaemia on Patients With Fibrotic Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Quality of life measured by King's Brief Interstitial Lung Disease Questionnaire (K-BILD)
研究概览
简要总结
Home sleep studies - which allow the measurement of breathing while the person sleeps - will be performed on patients with fibrotic interstitial lung disease attending two of the UK's largest respiratory medicine services.The study will investigate at how symptoms, and breathing and exercise tests differ between these two groups after 12 months of study.
详细描述
The interstitial lung diseases are a group of diseases in which patients develop uncontrolled scarring (called fibrosis) within the lung. This causes failure of the lung and patients become progressively more breathless over time. The commonest of these diseases is idiopathic pulmonary fibrosis and this is a devastating condition with a survival of 3-5 years.
Many people with fibrotic interstitial lung diseases have disrupted sleep as well as low oxygen levels at night or obstructive sleep apnoea (OSA - pauses in breathing at night time due to obstruction of the upper airway).
Patients with low oxygen levels at night have a worse quality of life, with fatigue during the day and survive for less long.
102 patients from specialist clinics at Guy's and St Thomas' and the Royal Brompton and Harefield NHS Foundation Trusts will be recruited. This research is funded by a grant from the British Lung Foundation. The investigators aim to compare patients with and without low oxygen levels at night by observing how their disease and quality of life changes over a year.
Patients will be asked to complete a two-night home sleep study which will involve wearing a probe over the finger connected to a sensor on the wrist. Patients will also be provided with a home spirometer to measure their breathing at home daily during the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MDT diagnosis of fibrotic interstitial lung disease including but not limited to idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonitis (NSIP), chronic hypersensitivity pneumonitis (CHP), fibrotic organising pneumonia and unclassifiable fibrotic lung disease.
- •Competent to provide written consent in English
排除标准
- •Presence of an underlying connective tissue disease
- •Daytime/resting hypoxaemia with pO2 <8.0
- •Other indication for oxygen therapy
- •3% ODI >15 events/hour studied or established on CPAP
- •Predominant emphysema on CT
- •Inability to provide informed consent or complete health-related quality of life questionnaires in English
- •Current participation in a research project which might alter lung function or sleep study results
结局指标
主要结局
Quality of life measured by King's Brief Interstitial Lung Disease Questionnaire (K-BILD)
时间窗: 0 months,12 months
Change in K-BILD score from baseline at 12 months in patients with nocturnal hypoxaemia vs those without (defined as time spent with SpO2\<90% of \> 10% total sleep time)
次要结局
- Six-minute walk test (6MWT)(0 months 6 months, 12 months)
- Mortality(12 months)
- Diffusion capacity of the lung for carbon monoxide (DLCO)(12 months)
- Forced vital capacity (FVC)(12 months)
- Exacerbation frequency and hospitalisation(12 months)
- Insomnia Severity Index (ISI)(0 months, 6 months, 12 months)
- Pittsburgh Sleep Quality Index (PSQI)(0 months, 6 months, 12 months)