Assessment of Continuous Positive Airway Pressure Therapy in IPF
Purpose
The purpose of this study is to evaluate whether biomarkers of lung injury and remodeling are responsive to effective continuous positive airway pressure (CPAP) treatment in adults with idiopathic pulmonary fibrosis (IPF) and moderate-to-severe obstructive sleep apnea (OSA).
Conditions
- Interstitial Lung Disease
- Obstructive Sleep Apnea
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Participants with moderate-to-severe OSA will be treated for 12 weeks with Auto-CPAP followed by withdrawal of auto-CPAP
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Moderate to Severe OSA - treated |
Moderate-to-severe OSA Treated with and adherent to Auto-CPAP |
|
|
Experimental Moderate to Severe OSA - withdrawal |
Moderate-to-severe OSA Withdrawal of Auto-CPAP |
|
Recruiting Locations
New York, New York 10032
More Details
- NCT ID
- NCT03901534
- Status
- Recruiting
- Sponsor
- Columbia University
Detailed Description
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.