Assessment of Continuous Positive Airway Pressure Therapy in IPF
关键词
抽象
描述
Idiopathic pulmonary fibrosis (IPF) is a progressive fibrotic disease of the peripheral lung parenchyma that affects 0.5% of older adults in the U.S. and confers a very poor median survival. Repetitive injury to the lung with abnormal healing likely results in fibrosis as treatment of those risk factors that cause these injuries may improve outcomes. Obstructive sleep apnea (OSA), a form of sleep disordered breathing, is highly prevalent in adults with IPF and may be a risk factor in IPF by exerting peripheral tractional stress on the lung and promoting oxidative injury by intermittent hypoxia. Effective treatment of OSA with continuous positive airway pressure (CPAP) reduces the number of obstructive events in OSA and therefore may reduce repetitive injury to the lung in adults with IPF.
Participants in this study will undergo polysomnography to determine whether they have OSA, and if so, its severity based on the apnea-hypopnea index (AHI, events/ hour). Those participants with moderate-to-severe OSA will undergo CPAP treatment for up to 48 weeks with an interim period of withdrawal of CPAP. The primary aim of this study will examine the effect of CPAP treatment and its withdrawal and re-initiation on biomarkers of lung injury and remodeling in adults with IPF and moderate-to-severe OSA who are adherent to CPAP (expected sample size for this group is 30). The study will stop enrollment after 30 participants in this group are enrolled.
日期
| 最后验证: | 04/30/2020 |
| 首次提交: | 04/01/2019 |
| 提交的预估入学人数: | 04/01/2019 |
| 首次发布: | 04/02/2019 |
| 上次提交的更新: | 05/26/2020 |
| 最近更新发布: | 05/28/2020 |
| 实际学习开始日期: | 10/31/2020 |
| 预计主要完成日期: | 11/30/2022 |
| 预计完成日期: | 11/30/2022 |
状况或疾病
干预/治疗
Device: Moderate to Severe OSA - treated
Other: Moderate to Severe OSA - withdrawal
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Other: Moderate to Severe OSA - treated Moderate-to-severe OSA Treated with and adherent to Auto-CPAP | Device: Moderate to Severe OSA - treated Use of Auto-CPAP |
| Experimental: Moderate to Severe OSA - withdrawal Moderate-to-severe OSA Withdrawal of Auto-CPAP | Other: Moderate to Severe OSA - withdrawal Withdrawal of Auto-CPAP |
资格标准
| 有资格学习的年龄 | 50 Years 至 50 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: 1. Informed consent 2. Age equal to or greater than 50 years 3. Diagnosis of IPF as defined by the 2018 ATS/ERS/JRS/ALAT guidelines Exclusion Criteria: 1. Clinically significant lung disease other than IPF 2. Planned change to the IPF treatment during the study period 3. Known contraindication to CPAP 4. Current use of CPAP, an oral appliance, or hypoglossal nerve stimulation for treatment of OSA 5. Current cigarette smoking (past 4 weeks) 6. Lower respiratory tract infection in the past 60 days. (Upper respiratory tract infection is not a contraindication) 7. History of life-threatening cardiac arrhythmias 8. Known chronic heart failure (Left ventricle ejection fraction < 45% or echo evidence of right ventricle dysfunction or pulmonary hypertension) 9. Chronic opiate analgesic use 10. History of stroke or spinal cord injury 11. History of sleepiness-related automobile accident within past year of enrollment 12. Expected survival time in the opinion of the investigator of less than 6 months 13. Commercial driver's license or occupation |
结果
主要结果指标
1. Serum matrix metalloproteinase-7 (MMP-7, ng/mL) [Up to 24 Weeks]
2. Serum surfactant protein-D (SP-D, ng/mL) [Up to 24 Weeks]
3. Serum Angiopoietin-2 (Ang-2, ng/mL) [Up to 48 Weeks]
4. Serum surfactant protein-A (SP-A, ng/mL) [Up to 24 weeks]
次要成果指标
1. Forced vital capacity (FVC) [24 and 48 weeks]
2. Diffusing capacity of the lung for carbon monoxide (DLCO) [24 and 48 weeks]
3. Score on St. George's Respiratory Questionnaire (SGRQ) [24 and 48 weeks]
4. Score on University of California San Diego (USCD) Shortness of Breath Questionnaire (SOBQ) [24 and 48 weeks]
5. Score on Epworth Sleepiness Scale (ESS) [24 and 48 weeks]
6. Sleep Apnea Quality of Life Index (SAQLI) [24 and 48 weeks]
7. Assess Quality of life in Idiopathic Pulmonary Fibrosis (ATAQ-IPF) [24 and 48 weeks]
8. Gastroesophageal Reflux Disease Questionnaire (GERD-Q) [24 and 48 weeks]
9. Cough Visual Analog Scale [24 and 48 weeks]
其他成果措施
1. Concentration of CA125 (U/mL) [Up to 48 Weeks]
2. Concentration of CA19-9 (U/mL) [Up to 48 Weeks]
3. Concentration of Osteopontin (ng/mL) [Up to 48 Weeks]
4. Moderate to Severe OSA Non-Adherent to CPAP [Up to 10 years]
