Effect of Continuous Positive Airway Pressure (CPAP) on Abnormal Gastroesophageal Reflux and Lung Inflammation in Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Composite Biomarker Score
研究概览
简要总结
This study will evaluate the effect of CPAP therapy on esophageal pH and lung inflammation in patients with idiopathic pulmonary fibrosis (IPF) and sleep apnea.
详细描述
Participants in this study will have an overnight sleep study done while wearing a 24 hour pH monitor in the esophagus. If the participant has sleep apnea, he or she will be randomly assigned to receive either CPAP treatment or no CPAP treatment. After 4-8 weeks, the participant will have another overnight sleep study with 24 hour pH monitoring. Blood will also be collected at both time points and again after 6 months to measure biomarkers that are related to lung inflammation.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study investigators and care providers will be blinded and not involved in any CPAP or no CPAP related set-up, instruction, or device troubleshooting during the course the treatment phase. Lab personnel performing biomarker analysis will only have access to subject study ID and not treatment group assignments.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed diagnosis of IPF based on the 2018 IPF guidelines
- •high likelihood of OSA based on the STOP-BANG measure, with a score of 3 or greater
- •patients on nintedanib, or in whom nintedanib will be initiated prior to enrollment in the study
- •able to participated in 24hr pH monitoring
- •able to comply with CPAP treatment
- •able to provide written informed consent prior to any study procedures
- •willing to complete all study measurements and assessments in compliance with the protocol
排除标准
- •interstitial lung disease caused by conditions other than IPF
- •severe concomitant illness limiting life expectancy (< 1 year)
- •residual lung volume > or equal to 120% of predicted
- •obstructive lung disease: FEV1/FVC ratio < 0.70
- •current drug or alcohol dependence
- •patients who are unable to tolerate nintedanib
- •patients who are unable to use CPAP or are unwilling to participate in the 24 hr pH probe placement
- •patients who were diagnosed with recent IPF exacerbation within 4 weeks of enrollment (may be rescheduled for enrollment once recovered)
- •patients who have had prior nasal surgery or trauma that would make pH probe placement difficult
- •patients on anticoagulation (aspirin is not an exclusion)
研究组 & 干预措施
CPAP
Subjects randomized to the treatment arm, will receive continuous positive airway pressure (CPAP) while sleeping via an autoPAP device for 4-8 weeks.
干预措施: Positive Airway Pressure (Device)
No CPAP
Subjects assigned to the no CPAP group will not have any intervention for a 4-8 week period.
结局指标
主要结局
Composite Biomarker Score
时间窗: 4-8 weeks
The primary outcome will be a composite value that is a weighted average of z-scores of the biomarkers MMP1, MMP7, IL-8, KL-6, and CXCL13, weighted by the univariate effect sizes of each biomarker. MMP1, MMP7, IL-8, KL-6, and CXCL13 will be measured using enzyme linked immunosorbent assays (ELISA) for these analytes. (Z-score is a unitless number, as is the weighted average.)
次要结局
- Biomarker of Lung Inflammation: IL-8(4-8 weeks)
- Biomarker of Lung Inflammation: KL-6(4-8 weeks)
- Biomarker of Lung Inflammation: MMP1(4-8 weeks)
- Esophageal pH During Sleep(4-8 weeks)
- Composite Biomarker Score at Six Months(6 months)
- FVC change(6 months)
- Biomarker of Lung Inflammation: MMP7(4-8 weeks)
- Biomarker of Lung Inflammation: CXCL13(4-8 weeks)
- 24hr-Esophageal pH(4-8 weeks)