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Assessment of Continuous Positive Airway Pressure Therapy in IPF

Study 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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	50 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03901534
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Columbia University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Sanja Jelic, MDDaniel J Gottlieb, MD
Principal Investigator Affiliation	Columbia UniversityBrigham and Women's Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Interstitial Lung Disease, Obstructive Sleep Apnea

Additional Details

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.

Arms & Interventions

Arms

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

Interventions

Device: - Auto-CPAP

Use of Auto-CPAP

Other: - Withdrawal of Auto-CPAP

Withdrawal of Auto-CPAP

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Columbia University Medical Center, New York, New York

Status

Recruiting

Address

Columbia University Medical Center

New York, New York, 10032

Site Contact

Alondra Jimenez Holguin

[email protected]

212-342-0256